Radiology Sponsored Research

PROTOCOL

D8312C00002, Version 1.0, dated 19 Feb 2026 (DURGA-5) — “A Phase III, Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy.” Sponsor: AstraZeneca AB. IND 030204.

MODALITY

1. PET/CT (total body) — primary imaging for soft-tissue plasmacytomas and lytic bone lesions; required for all participants at screening. If plasmacytomas are present, PET/CT is repeated during treatment/follow-up, generally every 3 months, with frequency reducible to every 6 months after confirmed CR/sCR. 
2. Whole-body CT or MRI — may be used when PET/CT is not available or cannot be performed. 
3. TTE or MUGA — used for cardiac assessment; required at screening (an SOC study within the previous 8 weeks is acceptable) and subsequently as clinically indicated.

SYNOPSIS

Phase III, open-label, randomized, multicenter trial in patients with newly diagnosed multiple myeloma (NDMM) who are ineligible for autologous stem cell transplantation (ASCT) as initial therapy. After initial standard induction with IsaVRd or DRd, eligible responders are randomized 1:1 to Arm A: AZD0120 CAR-T, following apheresis, optional bridging therapy and lymphodepletion, versus Arm B: continued standard therapy (IsaRd or DRd). Approximately 750 patients will be randomized (375 per arm). AZD0120 is a dual-targeting autologous CAR-T therapy directed against BCMA and CD19. The dual primary endpoints are PFS by BICR using IMWG criteria and MRD-negative CR rate at 9 months.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

R5458-ONC-2246 (LINKER-MM5), Original protocol, approved 15 Jul 2025 — "An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma." Sponsor: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591. Compound: Linvoseltamab (REGN5458). IND No. 138791; EU CT No. 2024-519504-27-00.

MODALITY

Whole-body 18F-FDG PET/CT — preferred baseline and follow-up imaging method to detect skeletal lesions and extramedullary plasmacytomas; also usable to measure plasmacytomas if the CT component is of diagnostic quality

Whole-body MRI (with diffusion-weighted MRI) — co-preferred baseline method with PET/CT; required for plasmacytomas that cannot be accurately measured on non-contrast CT
Whole-body low-dose CT — acceptable alternative only if neither PET/CT nor MRI can be performed

Diagnostic contrast-enhanced CT — acceptable alternative for plasmacytoma evaluation if IV contrast is not contraindicated
Bone marrow aspirate and/or core biopsy — performed at suspected CR to confirm plasma cell clearance

Bone marrow aspirate for MRD — assessed at suspected CR, 12 months post-treatment start, then annually to confirm sustained MRD negativity

Systemic therapy — Arm A: Linvoseltamab monotherapy (IV); Arm B: Linvoseltamab + Carfilzomib (IV); Arm C (standard-of-care): DKd (Daratumumab SC + Carfilzomib IV + Dexamethasone), KPd (Carfilzomib + Pomalidomide PO + Dexamethasone), Kd (Carfilzomib + Dexamethasone), or PVd (Pomalidomide PO + Bortezomib SC + Dexamethasone)

SYNOPSIS

A randomized, open-label, multicenter Phase 3 study (~915 participants total) comparing linvoseltamab monotherapy and linvoseltamab + carfilzomib against standard-of-care combination regimens (DKd, PVd, KPd, or Kd) in patients with relapsed/refractory multiple myeloma (RRMM) who received 1–3 prior lines of therapy including lenalidomide and either a proteasome inhibitor or anti-CD38 antibody. 

The study has two parts:

• Part 1 (safety lead-in, ~30 participants, 1:1): evaluates a condensed D1/D4 linvoseltamab step-up schedule as monotherapy (Arm A) or + carfilzomib (Arm B) to select recommended Phase 3 regimens (RP3Rs) for Part 2.

• Part 2 (~885 participants, 1:1:1): randomizes to Arm A (linvoseltamab monotherapy), Arm B (linvoseltamab + carfilzomib), or Arm C (standard therapy — DKd/PVd/KPd/Kd), stratified by prior lines of therapy/triple-class exposure status, age (<70 vs ≥70), and ISS stage (I/II vs III).

Primary endpoints (dual): proportion achieving MRD-negative complete response (CR) at 12 months (per IMWG criteria, BIRC-assessed, 10⁻⁵ sensitivity), and progression-free survival (PFS) per IMWG criteria by BIRC. Secondary endpoints: overall survival (OS); best response rates (ORR, ≥VGPR, ≥CR); duration of response (DOR), time to progression (TTP), time to next treatment (TTNT), PFS2; MRD-negative CR at any time and its duration/sustainment; safety/tolerability (TEAEs, AESIs, SAEs); linvoseltamab PK and immunogenicity (ADA); soluble BCMA concentrations; and patient-reported HRQoL (EORTC QLQ-C30, EORTC QLQ-MY20, EQ-5D-5L, FACIT GP5). Treatment continues until progressive disease, death, unacceptable toxicity, withdrawal of consent, or study end, followed by post-treatment (up to 90 days) and long-term survival follow-up.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

CA240-0029, Protocol Amendment 01, dated 24 Jun 2025 — “A Randomized Phase 2/3 Study of BMS-986504 in Combination with Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants with Homozygous MTAP Deletion.

MODALITY

1. CT or MRI (chest/abdomen/pelvis + other disease sites) — baseline tumor imaging within 28 days before randomization; includes contrast-enhanced CT chest and contrast-enhanced CT/MRI abdomen, pelvis, and other known/suspected disease sites. On-study imaging is every 6 weeks (±7 days) through Week 48, then every 12 weeks (±7 days). 

2. MRI (brain) — brain MRI with and without contrast at baseline; if brain metastases are present at baseline, repeat every 12 weeks (±7 days). If there is no history/suspicion of brain metastases, subsequent brain imaging is clinically indicated. CT brain is acceptable if MRI is contraindicated. 

3. Bone scan / NaF-PET — may be collected according to local standards when clinically indicated; bone scans are not adequate for RECIST target-lesion assessment. 

4. FDG-PET / PET-CT — may be used; if the CT component of PET-CT meets diagnostic CT requirements, it can be used for RECIST v1.1 measurements. 

5. MUGA or ECHO — used for cardiac/LVEF assessment at screening and thereafter as clinically indicated.

SYNOPSIS

Global, multicenter, randomized, blinded Phase 2/3 trial evaluating BMS-986504, a PRMT5-targeted therapy, added to pembrolizumab + chemotherapy as first-line treatment for previously untreated metastatic NSCLC with homozygous MTAP deletion. 

Phase 2 enrolls approximately 90 patients randomized 2:2:1:1 to BMS-986504 400 mg, BMS-986504 600 mg, or matching placebo, all with pembrolizumab + chemotherapy, to select the BMS-986504 dose for Phase 3. 

Phase 3 then compares the selected BMS-986504 dose + pembrolizumab + chemotherapy against placebo + pembrolizumab + chemotherapy. The dual Phase 3 primary endpoints are PFS by BICR using RECIST v1.1 and overall survival (OS).

RADIOLOGIST/CO-PI

TBA

PROTOCOL

EA4231 (ECOG-ACRIN), NCT06649812, Version Date: May 20, 2025. "A Phase II Study of Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed or Refractory CD10-Negative Diffuse-Large B-Cell Lymphoma (DLBCL) and High-Grade B-Cell Lymphoma with MYC and BCL2 rearrangements (HGBCL-DH-BCL2)." Study Chair: Christopher Melani, MD. IND Sponsor: DCTD, NCI

MODALITY

• CT (neck, chest, abdomen, pelvis) — preferred, with IV and PO contrast unless contraindicated

• MRI — may be used if preferred to assess disease

• PET (18F-FDG PET/CT) — used when clinically indicated; the same imaging type used at screening should be used at follow-up for consistent response assessment

SYNOPSIS

A multi-center Phase 2 trial evaluating the ViPOR regimen (Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, Revlimid/lenalidomide) in relapsed/refractory CD10-negative DLBCL and HGBCL-DH-BCL2 (double-hit lymphoma with MYC and BCL2 rearrangements). 

Primary objective: complete response (CR) rate. Secondary objectives include CR rate by DLBCL subtype (ABC vs. non-ABC), overall response rate, duration of response, event-free/progression-free/overall survival, and safety. Exploratory objectives use molecular profiling (Lymph2Cx gene expression, whole exome/genome/RNA sequencing, ctDNA) to assess response by molecular and genetic subtype. Response is assessed using standard lymphoma criteria (Lugano-style, PET/CT-based for FDG-avid lymphomas or CT-based when PET isn't used), with imaging performed pre-cycle 3 and at defined follow-up intervals, and years 1–2 follow-up imaging every 6 months.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

AREN2231, Version Date 07/17/2025, Amendment #1 — “Risk Adapted Treatment of Unilateral Favorable Histology Wilms Tumors (FHWT).” A Children's Oncology Group (COG) Groupwide Phase 3 Study, exempt from IND requirements per 21 CFR 312.2(b). Companion reference document: APEC14B1 Manual of Procedures (MOP), dated 02/06/2026, “PROJECT:EVERYCHILD” — governs specimen and imaging submission logistics, including the Renal Tumors (REN) section (Section 12.0).

MODALITY

• CT/MRI of abdomen and pelvis — required at baseline for all patients, continued through nephrectomy/confirmed complete response

• CT chest — required at baseline for all patients; continued if lung metastases present, with rapid central review of Cycle-2 chest CT for lung-metastatic patients

• Abdominal ultrasound / chest x-ray — recommended once cross-sectional imaging confirms complete response

• CT/MRI or bone/PET scan of metastatic sites — for suspected extrapulmonary metastases (brain, soft tissue, bone)

• Central imaging review is coordinated through IROC (Imaging and Radiation Oncology Core), with diagnostic images submitted via TRIAD in DICOM format per the APEC14B1 MOP.

SYNOPSIS

AREN2231 is a COG Phase 3 trial for children newly diagnosed with unilateral Favorable Histology Wilms Tumor (FHWT). Patients first enroll on the umbrella screening/biospecimen protocol APEC14B1 for rapid central pathology review and initial stratum assignment, then enroll on AREN2231. The study introduces an expanded risk-stratification model incorporating age, chromosome 1q gain, LOH of 1p/16q/11p15, response after two cycles of chemotherapy, post-chemotherapy stage/histology in delayed-nephrectomy patients, lymph node status, extrapulmonary metastatic disease, and epithelial histology — aiming to improve outcomes in higher-risk cohorts (EFS ≤80%) while safely reducing therapy in lower-risk cohorts (EFS ≥84%). Six chemotherapy regimens are used across risk groups: EE-4A, DD-4A, VIVA, M, MVI, and UH-3, alongside expanded nephrectomy-only management for very-low-risk patients. Real-time central pathology and imaging review determine risk stratification and treatment assignment throughout. Exploratory aims span radiology, surgery, radiation oncology, pathology, and tumor biology. 

Amendment #1 (this version) is primarily a safety correction — restoring an omitted radiation therapy risk to the informed consent document and adding a required GFR/creatinine-clearance check for carboplatin dosing in Regimen UH-3 — plus administrative and clarity edits.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

GO46021, Version 2 — “A Phase Ib/II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer Who Have Previously Progressed During or After a CDK4/6 Inhibitor.” Sponsor: Genentech, Inc.; Roche (China) Holding Ltd. is co-sponsor in China only. IND 175766.

MODALITY

1. CT or MRI (chest/abdomen/pelvis) — CT with contrast is the standard tumor assessment; if contrast CT is contraindicated, non-contrast chest CT + MRI of the abdomen/pelvis can be used. Imaging occurs at screening, Q8W for the first 2 years, then Q12W until progression. 

2. Bone scan — required for all participants at screening; then approximately Q24W until progression. 

3. MRI or CT (brain) — performed at screening for previously treated brain metastases or when clinically indicated; MRI is required to clarify an equivocal brain CT. 

4. PET-CT — may be used to confirm the presence/disappearance of bone lesions; if the CT portion is being used for tumor assessment, it must meet full diagnostic CT standard

SYNOPSIS

Phase Ib/II, multicenter, open-label, randomized breast cancer study evaluating GDC-4198, a novel CDK4/2 inhibitor, in patients with locally advanced or metastatic ER-positive/HER2-negative breast cancer whose disease progressed during or after prior CDK4/6 inhibitor therapy. Phase Ib evaluates the safety and pharmacokinetics of GDC-4198 alone and GDC-4198 + giredestrant and identifies a safe/active combination dose. Phase II compares two GDC-4198 dose levels + giredestrant against abemaciclib + giredestrant. The primary Phase II endpoint is progression-free survival (PFS) by investigator assessment using RECIST v1.1.

RADIOLOGIST/CO-PI

Alan Chiang, MD, PhD

PROTOCOL

BGB-43395-302, Version 3.0, dated 30 Apr 2026 — “An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease.” Sponsor: BeOne Medicines GmbH. IND 181575.

MODALITY

• CT or MRI (chest/abdomen/pelvis) — primary tumor imaging; CT is preferred. Baseline within 28 days before treatment, then every 8 weeks (±7 days) for the first 72 weeks, then every 12 weeks (±7 days). 

• MRI (brain) — preferred for brain imaging and performed if clinically indicated. 

• Bone scan (technetium-99m) or PET — performed at screening if clinically indicated, particularly for bone metastases; may be repeated when CR or bone progression is suspected. 

• PET/CT — CT portion may be used for tumor assessment if it meets diagnostic CT standards. Tumor response is assessed by RECIST v1.1 with BICR.

SYNOPSIS

Open-label, randomized, multicenter Phase 3 trial in approximately 1,056 patients with previously untreated advanced or metastatic HR-positive/HER2-negative breast cancer. Patients are randomized 1:1 to Arm A: BGB-43395 400 mg twice daily + letrozole versus Arm B: investigator's choice of abemaciclib, palbociclib, or ribociclib + letrozole. The study evaluates whether the selective CDK4 inhibitor BGB-43395 can improve efficacy and potentially tolerability compared with standard CDK4/6 inhibition. The primary endpoint is PFS by BICR using RECIST v1.1; overall survival is the key secondary endpoint.

RADIOLOGIST/CO-PI

Alan Chiang, MD, PhD

PROTOCOL

NRG-HN015 — A Phase II Randomized Trial of Neoadjuvant Chemotherapy or Chemo-Immunotherapy in Patients with Recurrent/Persistent PD-L1 Enriched Squamous Cell Carcinoma of the Head and Neck Undergoing Salvage Surgery (NEOPOLIS); ClinicalTrials.gov NCT07195734; Version Date October 10, 2025

MODALITY

• Diagnostic-quality neck CT — required at baseline (≤45 days pre-registration); may be obtained as part of PET/CT acquisition; contrast-enhanced unless contraindicated

• PET/CT (with attenuation-correction CT of neck, chest, and abdomen) — at baseline, after systemic therapy in Arms 2/3 (within 3 weeks of cycle 2, or 6 weeks of cycle 1), and in follow-up at 12 weeks post-treatment then as clinically indicated per institutional guidelines

• MRI — permitted alternative to CT if CT is not obtainable/contraindicated; imaging modality must stay consistent for a given patient throughout the trial

• Salvage Surgery (SS) — resection performed in all arms, timing dependent on arm assignment

• Systemic Therapy — carboplatin + paclitaxel (Arms 2 & 3), with cemiplimab (REGN2810) added in Arm 3, given neoadjuvantly prior to SS\

• Post-Operative Radiation Therapy (PORT) ± cisplatin — given only if indicated by high-risk pathologic features identified after surgery, in any arm

SYNOPSIS

A Phase II, three-arm, 1:1:1 randomized trial for patients with pathologically confirmed locally recurrent or persistent PD-L1-enriched squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx, deemed resectable by a Head and Neck Surgical Oncologist. Patients are stratified by primary tumor site (oropharynx/oral cavity vs. larynx/hypopharynx), stage (rT4a or rN3a vs. other), and prior use of PD-1/PD-L1 inhibitors in the definitive setting, then randomized to:

• Arm 1: Salvage Surgery (SS) alone

• Arm 2: Carboplatin + Paclitaxel → SS

• Arm 3: Carboplatin + Paclitaxel + Cemiplimab (REGN2810) → SS
   

All arms may receive standard post-operative radiation therapy + cisplatin if indicated by high-risk pathologic features. Primary objective: compare investigator-assessed event-free survival (EFS) between neoadjuvant systemic therapy (± immunotherapy) followed by SS versus SS alone. Secondary objectives: disease-free survival, overall survival, distant metastasis, acute/late toxicity (CTCAE v5.0) and surgical complications, radiographic response (RECIST 1.1) and pathologic response to neoadjuvant therapy in the experimental arms. Exploratory objectives: outcomes stratified by PD-L1 combined positive score (<20 vs. ≥20), and the relationship between surgical quality benchmarks (margin assessment, cervical lymph node harvest via central surgical review) and oncologic outcomes.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

RMC-9805-305 (RASolute 305), Version 3.0, dated 10 February 2026 (Amendment 2) — "A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma." Sponsor: Revolution Medicines, Inc., 700 Saginaw Drive, Redwood City, CA 94063. IND No. 178874; EU CT No. 2025-524928-21-00. Prior versions: Original Protocol V1.0 (18 Dec 2025), Amendment 1/V2.0 (19 Jan 2026).

MODALITY

• CT (Neck-Chest-Abdomen-Pelvis, with IV contrast) — preferred/optimal option; contrast-enhanced CT of chest/abdomen/pelvis (with dedicated pancreatic-phase and portal-venous-phase acquisitions) required at screening and every 8 weeks (±7 days) during treatment until documented disease progression
• MRI (Neck-Chest-Abdomen-Pelvis, with Gadolinium contrast) — used with non-contrast Chest CT if iodinated contrast is medically contraindicated, or as full-body MRI if CT cannot be performed at all
• Non-contrast CT — Neck-Chest-Abdomen-Pelvis without IV contrast, lowest-preference fallback
• Brain MRI (with Gadolinium contrast) — required at screening/baseline (within 4 weeks of C1D1) and thereafter as clinically indicated
• Brain CT (with/without IV contrast) — alternative to Brain MRI only if MRI is not possible
• 99mTc Bone Scan — as clinically indicated for suspected bony metastatic disease
• 18F-FDG-PET/CT (whole body) — permitted alternative for tumor measurement if CT component meets diagnostic quality standards
• Systemic therapy: Zoldonrasib (oral, RMC-9805) or matching placebo, plus Investigator-choice chemotherapy — modified FOLFIRINOX (mFFX: leucovorin, 5-fluorouracil, irinotecan, oxaliplatin) or Gemcitabine plus Nab-paclitaxel (GnP)

SYNOPSIS

A Phase 3, global, randomized, double-blind, placebo-controlled, 2-arm study (~670 patients, ~150 sites) evaluating zoldonrasib (RMC-9805) — a potent, oral, mutant-selective covalent inhibitor targeting the active (GTP-bound) state of RAS G12D — in patients with previously untreated, first-line metastatic KRAS G12D-mutated pancreatic adenocarcinoma. Patients are randomized 1:1 to:
 

• Arm A: Zoldonrasib + Investigator-choice chemotherapy (mFFX or GnP)

• Arm B: Placebo + Investigator-choice chemotherapy (mFFX or GnP)
   

Chemotherapy choice is made by the Investigator prior to randomization (with enrollment caps to ensure ≥40% representation of each regimen) and stratification by ECOG status, chemotherapy choice, liver metastases, and geographic region. Primary endpoints: progression-free survival (PFS, Investigator-assessed per RECIST v1.1) and overall survival (OS). Secondary endpoints: PFS, objective response rate (ORR), and duration of response (DOR) per BICR and Investigator; safety/tolerability (TEAEs, TRAEs, SAEs); health-related quality of life (EORTC QLQ-PAN26 pain scale, EORTC QLQ-C30 global health status); and zoldonrasib pharmacokinetics. Exploratory endpoints: time to response (TTR), predictive/prognostic/resistance biomarkers (CA 19-9, DNA/RNA/protein), exposure-response relationships, additional HRQoL domains (EORTC QLQ-C30/PAN26, PRO-CTCAE, FACT-GP5, EQ-5D-5L). Total estimated study duration is approximately 4 years, with imaging tumor assessments (CT/MRI/PET-CT) performed at screening and every 8 weeks during treatment until documented progression per RECIST v1.1.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

STUDY00007884/GLP1 IIT (listed as "PENDING"); Study Name/Title GLP-1 Receptor Agonist plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer, v1.0 dated 03/03/2026.

MODALITY

CT, MRI, Nuc Med, and PET-CT

SYNOPSIS

Pilot safety study combining a GLP-1 receptor agonist (semaglutide) with SOC chemotherapy in 30 patients (≥18 yrs, BMI ≥23) across metastatic pancreatic (n=10), colorectal (n=10), and hepatocellular carcinoma (n=10). Primary objective: safety; secondary: tolerability/preliminary efficacy; exploratory: metabolic/inflammatory markers, weight, patient-reported QoL. Semaglutide dosed weekly SC with titration (0.25→0.5→1→1.7→maintenance 2.4 or 1.7 mg). Study duration 18 months, participant duration 12 months. Post-processing not required; images stored in PACS. Internally funded (UACC IIT Incubator/Departmental Funds), investigator-initiated (IIS), IRB of record is UA HSPP. NCT number still PENDING.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

JZP598-206-02, Protocol Amendment 02, dated 14 Apr 2025 — “A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206).” Sponsor: Jazz Pharmaceuticals Ireland Limited. IND 126269

MODALITY

1. CT or MRI (chest/abdomen/pelvis + other involved areas) — main tumor imaging for RECIST v1.1; performed at screening, then every 6 weeks for the first 54 weeks, then every 9 weeks until disease progression. All scans are submitted for Independent Central Review (ICR). 

2. Bone scan (scintigraphy) — used when needed for bone disease; after screening it is repeated only if clinically indicated. New bone lesions are confirmed with targeted X-ray, CT with bone windows, or MRI, with MRI preferred for confirmation. 

3. MRI (brain) — required at screening for all Cohort 2 breast cancer patients, NSCLC patients in Cohort 1, and patients with known/suspected brain metastases. If MRI is not feasible, contrast CT may be used. 

4. ECHO or MUGA — used to assess cardiac function/LVEF; baseline, 6 weeks, then every 12 weeks thereafter.

SYNOPSIS

Phase 2, open-label, multicenter study evaluating zanidatamab (JZP598) monotherapy in patients with previously treated, locally advanced/unresectable or metastatic HER2-expressing solid tumors. Zanidatamab is a biparatopic HER2-targeted antibody. The primary efficacy endpoint is confirmed objective response rate (cORR) by Independent Central Review using RECIST v1.1. The study includes multiple tumor cohorts, including HER2-overexpressing cancers such as breast cancer, NSCLC, colorectal and other solid tumors; biliary tract cancer is excluded because zanidatamab data were generated separately.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

CA2660003 (ROSETTA CRC-203), Protocol Amendment 01, dated 09-Oct-2025 — “A Blinded, Randomized Phase 2/3 Study of Pumitamig in Combination with Chemotherapy Versus Bevacizumab in Combination with Chemotherapy in Participants with Previously Untreated, Unresectable, or Metastatic Colorectal Cancer.” Compound: BMS-986545 (BNT327; PM8002)

MODALITY

1. CT (chest/abdomen/pelvis) — primary cross-sectional tumor imaging; IV contrast is recommended unless medically contraindicated. 

2. MRI (abdomen/pelvis) — may be used when appropriate, including when CT IV contrast is contraindicated. 

3. MRI (brain) — may be performed when brain imaging is required; suggested when CT contrast is contraindicated. 

4. PET/CT — diagnostic-quality CT acquired on a PET/CT scanner may be used when it meets study CT requirements. Imaging is evaluated using RECIST v1.1, with Phase 3 including BICR/independent review of progression.

SYNOPSIS

Randomized, blinded Phase 2/3 trial evaluating pumitamig + chemotherapy versus bevacizumab + chemotherapy as first-line treatment for previously untreated, unresectable or metastatic colorectal cancer. Phase 2 is dose optimization, comparing two pumitamig doses + FOLFOX/FOLFIRI against bevacizumab + FOLFOX/FOLFIRI. Phase 3 compares the selected pumitamig dose + FOLFOX, FOLFIRI, or CAPOX against bevacizumab + the same chemotherapy options. The trial evaluates whether pumitamig can improve outcomes compared with the bevacizumab standard-of-care regimen.

RADIOLOGIST/CO-PI

Hina Arif, MD, FSAR

PROTOCOL

GS-US-741-7756, Original Protocol dated 08 Dec 2025 — "A Phase 2, Open Label, Multicenter, Randomized Study, to Evaluate the Efficacy and Safety of Denikitug Monotherapy and Denikitug-based Combinations in Participants With Advanced Microsatellite Stable (MSS) Colorectal Cancer (CRC)" (internal compound name GS-1811). Plain language short title: "Study of Denikitug (GS-1811) Given Alone or With Nivolumab or With Chemotherapy in Adults with Advanced Colorectal Cancer." Sponsor: Gilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404. IND No. 151335; EU CT Number 2025-523984-39; ClinicalTrials.gov Identifier: Not available.

MODALITY

1. CT (Chest-Abdomen-Pelvis, with IV contrast) — optimal/preferred option; scans obtained at screening and every 6 weeks (±7 days) for the first 24 weeks, then every 8 weeks through Week 52, then every 12 weeks thereafter until progressive disease, new anticancer therapy, or death
2. MRI (Abdomen-Pelvis, with Gadolinium contrast) — used in combination with non-contrast Chest CT if IV iodinated contrast is medically contraindicated; also permitted as MRI Chest-Abdomen-Pelvis with contrast as a lower-preference option
3. Non-contrast CT — Chest-Abdomen-Pelvis without IV contrast, lowest-preference fallback option
4. Brain MRI (pre- and post-contrast) — preferred method if brain imaging is clinically indicated
5. Brain CT (pre-optional, post-contrast) — alternative to brain MRI if clinically indicated
6. Oral contrast (radio-opaque iodine/barium-based, or radiolucent whole milk/VoLumen®/water) — used adjunctively for luminal visualization

SYNOPSIS

A global Phase 2, open-label, multicenter, randomized trial (~170 participants, ~50 sites) evaluating denikitug (DEN, GS-1811) — alone or in combination — in advanced microsatellite stable (MSS) colorectal cancer patients who have received up to 2 prior lines of systemic therapy. Four arms:
 

• Arm A (n=40): Denikitug 30 mg IV Q8W monotherapy
• Arm B (n=40): Denikitug 30 mg IV Q8W + Nivolumab 480 mg IV Q4W
• Arm C (safety run-in ~n=10, then randomized n=40): Denikitug 30 mg IV Q8W + Bevacizumab 5 mg/kg IV (Days 1 & 15, Q4W) + oral Trifluridine-Tipiracil 35 mg/m² BID (Days 1-5 & 8-12, Q4W)
• Arm D (n=40, reference/SOC): Bevacizumab + Trifluridine-Tipiracil (same dosing as Arm C, without denikitug)
   

Primary endpoint: Objective response rate (ORR) per investigator assessment using RECIST v1.1. Secondary endpoints: duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety/tolerability (CTCAE v5.0), and pharmacokinetics/immunogenicity (anti-drug antibodies) of denikitug. Participants proceed through screening (≤28 days), treatment (~24 months for denikitug-containing arms, with NIVO/BVZ/FTD-TPI continuing per arm-specific rules), and safety/survival follow-up.

RADIOLOGIST/CO-PI

Hina Arif, MD, FSAR

PROTOCOL

INCA033890-303, Version 1, dated 03 Nov 2025 — "A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer." Sponsor: Incyte Corporation, Wilmington, DE. IND No. 163406. EU CT Number 2025-523735-19-00.

MODALITY

1. CT and MRI (no PET/nuclear medicine required):
2. CT/MRI — chest, abdomen, and pelvis (or other anatomical sites of disease) at screening and per the on-study imaging schedule
3. Brain imaging — required only if brain metastases are present at screening, with contrast-enhanced MRI preferred over contrast-enhanced CT whenever feasible
4. Imaging cadence: every 8 weeks (±7 days) for the first 18 months from the start of study treatment, then every 12 weeks (±14 days) thereafter, per RECIST v1.1, regardless of dose delays

SYNOPSIS

A global, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating INCA33890 (an investigational agent — likely a PD-1/PD-L1-directed or immune checkpoint-related biologic given the PD-L1 stratification) added to standard-of-care FOLFOX chemotherapy plus bevacizumab as first-line treatment for metastatic microsatellite-stable (MSS) colorectal cancer (CRC). Approximately 700 participants without prior systemic therapy for metastatic disease will be randomized to:

• INCA33890 arm: INCA33890 900 mg IV Q2W (Day 1 of each 14-day cycle) + FOLFOX (oxaliplatin, leucovorin, 5-FU) + bevacizumab 5 mg/kg Q2W
• Placebo arm: Placebo Q2W IV + the same FOLFOX + bevacizumab backbone

Randomization is stratified by tumor sidedness (left/right/transverse), PD-L1 expression (≥1% vs <1% by TAP), and presence of liver metastases; participants with PD-L1 <1% may be capped at 174. Patients who are MSI-H/dMMR or have BRAF V600E-mutated tumors are excluded (reflecting that those subgroups already have effective targeted first-line options). The primary endpoint is investigator-assessed progression-free survival (PFS) per RECIST v1.1, tested in both the PD-L1-positive population (H1) and the overall population (H2). Key secondary endpoints include overall survival (OS), objective response rate, duration of response, safety/tolerability (CTCAE v6.0), and patient-reported quality of life (EQ-5D-5L, EORTC QLQ-C30, FCSI-9). INCA33890/placebo is administered for up to ~2 years (52 cycles); total estimated participation is approximately 3 years including screening, treatment, and survival follow-up. An external Data Monitoring Committee (DMC) will oversee the study.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

C5731004/SGNDV-004, Amendment 03, dated 15-December-2025 — "A Phase 1b/2 Open-Label Study of Disitamab Vedotin in Combination with Other Anticancer Therapies in Solid Tumors" (Brief Title: "A Study of Disitamab Vedotin with Other Anticancer Drugs in Solid Tumors"). Sponsor: Seagen Inc., a wholly owned subsidiary of Pfizer (Bothell, WA, USA); Collaborator: RemeGen Co., Ltd. Regulatory identifiers: US IND 161436, EU CT 2023-507555-29, ClinicalTrials.gov NCT06157892.

MODALITY

Multiple imaging modalities are specified for tumor assessment:

• CT scan — required for chest; preferred modality for disease assessment of chest/abdomen/pelvis
• CT or MRI scan — abdomen, pelvis, and other sites of suspected disease involvement (contrast-enhanced unless contraindicated)
• MRI or CT scan of the brain (with contrast) — for participants with history of or signs/symptoms of CNS metastasis, at screening and every 8 weeks if involvement confirmed
• Full body bone scan (or other bone imaging techniques) — as clinically indicated
   

Response assessed per RECIST v1.1 by investigator (no independent/blinded central imaging review used)

SYNOPSIS

A Phase 1b/2, open-label, multicenter, three-part study (dose escalation → dose optimization → dose expansion) evaluating disitamab vedotin (RC48-ADC/DV/PF-08046051), a HER2-directed antibody-drug conjugate delivering MMAE, in combination with tucatinib (TUKYSA®, an oral HER2 tyrosine kinase inhibitor) in participants with HER2-expressing locally advanced/metastatic breast cancer (LA/mBC) and, originally, gastric/gastroesophageal junction adenocarcinoma (LA/mGC/GEJC) — though per this Amendment 03, enrollment of gastric cancer participants in the dose optimization and expansion phases has been closed (a sponsor business decision, not safety/efficacy/regulatory-driven), so the ongoing optimization/expansion phases now enroll only breast cancer participants (Cohorts A: HER2-low LA/mBC; B: HER2+ LA/mBC). Dose escalation used a starting disitamab vedotin dose of 1.25 mg/kg IV (Day 1 of each 2-week cycle) with tucatinib 300 mg PO BID (staggered start, Day 8 in Cycle 1), guided by DLT evaluation via a modified toxicity probability interval (mTPI) design under Safety Monitoring Committee oversight. The optimization phase compares two DV dose levels (~30 participants/cohort combined with expansion). Primary endpoints: incidence of DLTs/AE characterization (dose escalation) and ORR per RECIST v1.1 by investigator assessment (dose optimization/expansion) across HER2-low/HER2+ BC and (originally) GC/GEJC subgroups. Secondary endpoints include DOR, DCR, PFS, OS, PK parameters, and immunogenicity (ADA); exploratory endpoints include biomarker analyses and patient-reported outcomes (EORTC QLQ-C30/QLQ-OG25, PGIS/PGIC).

RADIOLOGIST/CO-PI

TBA

PROTOCOL

3082-CL-0301, Version 1.0, dated 30 Oct 2025 — "A Phase 3, Double-blind, Placebo-controlled, Randomized Study to Assess the Efficacy and Safety of ASP3082 in Combination with mFOLFIRINOX or NALIRIFOX as First-line Treatment in Participants with KRAS G12D-mutated Metastatic Pancreatic Adenocarcinoma." Sponsor: Astellas Pharma Global Development Inc. IND No. 159551. EU CT Number 2025-523684-38

MODALITY

• CT (preferred) — chest, abdomen, pelvis (CAP) with IV and oral contrast, at screening and per the imaging schedule
• MRI — used as an alternative when CT/IV contrast is medically contraindicated (abdomen/pelvis with/without gadolinium, per a tiered order of preference); MRI brain preferred over CT brain if brain imaging is required
   

Imaging cadence: every 8 weeks (±1 week) for the first 52 weeks, then every 12 weeks (±1 week) thereafter, until radiographic progression per RECIST v1.1, start of subsequent anticancer therapy, death, withdrawal, or loss to follow-up

SYNOPSIS

A pivotal, randomized (1:1), double-blind, placebo-controlled Phase 3 trial evaluating ASP3082 — a novel KRAS G12D-selective protein degrader — added to standard first-line chemotherapy (mFOLFIRINOX or NALIRIFOX) in adults with KRAS G12D-mutated metastatic pancreatic ductal adenocarcinoma (PDAC). Approximately 614 participants will be randomized across ~250 sites in Europe, Asia-Pacific, and the Americas to:

ASP3082 arm: ASP3082 600 mg IV QW (days 1, 8, 15, 22) + mFOLFIRINOX or NALIRIFOX (days 1 and 15) every 28-day cycle
Placebo arm: Placebo on the same schedule + the same chemotherapy backbone

NALIRIFOX will be capped at ~25% of the randomized population. The primary endpoint is overall survival (OS); key secondary endpoints include PFS (RECIST v1.1), time to improvement of pancreatic pain (TIPP), and time to worsening of quality of life (TWGQ). Total participant duration is approximately 17 months, including screening and follow-up. Rationale: KRAS G12D is one of the most common driver mutations in PDAC (~35–45% of cases); ASP3082 is a small-molecule VHL-based degrader designed to selectively eliminate the mutant KRAS G12D protein, with early Phase 1 data (study 3082-CL-0101) suggesting antitumor activity.

RADIOLOGIST/CO-PI

TBA

PROTOCOL

INCB161734-303, Version 1, dated 22 Dec 2025 — “A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D–Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303).” Sponsor: Incyte Corporation. IND 167563.

MODALITY

CT or MRI — used for tumor imaging at baseline and throughout the study; scans are assessed using RECIST v1.1 and submitted to the central imaging vendor (Clario). Imaging is generally performed every 8 weeks (±7 days) until radiographic disease progression.

SYNOPSIS

Randomized, double-blind Phase 3 trial in patients with previously untreated, KRAS G12D–mutated metastatic pancreatic ductal adenocarcinoma (PDAC). The study compares INCB161734 + standard chemotherapy against placebo + standard chemotherapy. The chemotherapy backbone is either mFOLFIRINOX or gemcitabine + nab-paclitaxel (GemNabP). INCB161734 is administered at 1200 mg once daily (QD), the dose selected based on prior safety, PK, pharmacodynamic, and efficacy data. The primary efficacy endpoints are overall survival (OS), progression-free survival (PFS) by BICR using RECIST v1.1, and objective response by BICR.

RADIOLOGIST/CO-PI

Hina Arif, MD, FSAR