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Recruiting Phase 2/3

A Study to Evaluate the Safety and Efficacy of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer

NCT07221357 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2/3
Started
2025-12-31
Last updated
2026-09-23

Condition(s) studied

Untreated, Unresectable, or Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

Pumitamig →FOLFOX →FOLFIRI →Bevacizumab →CAPOX →

Pumitamig: Specified dose on specified days

FOLFOX: Specified dose on specified days

FOLFIRI: Specified dose on specified days

Bevacizumab: Specified dose on specified days

CAPOX: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety and efficacy of pumitamig in combination with chemotherapy versus bevacizumab in combination with chemotherapy in participants with previously untreated, unresectable, or metastatic colorectal cancer

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participant must previously untreated, histologically confirmed recurrent or metastatic colorectal adenocarcinoma, not amenable to curative surgery. * Participant must have no known presence of mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) per historical results (a validated test should be used). * Participant must have no known presence of the gene that encodes the protein B-Raf (BRAF) V600E mutation per local testing. * Participant must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Exclusion Criteria * Participant must not have any untreated known central nervous system (CNS) metastases including brain, leptomeningeal and/or spinal cord compression. * Participant must not have any prior malignancy active within the previous 2 years, except for locally curable cancers that have been apparently cured and considered to be of low risk of recurrence. * Participant must not have significant cardiovascular disease, such as myocardial infarction, unstable angina, arterial thrombosis or cerebrovascular accident within 6 months prior to randomization, uncontrolled hypertension (≥ 160 systolic, and/or ≥ 100 diastolic mm Hg) despite optimal medical management, or congenital long QT syndrome. * Participant must not have prior systemic treatment with an anti-PD-1, anti-programmed death (ligand)-1 (PD-L1), anti-PD-L2, CD137 agonists, or anti-cytotoxic T-lymphocyte associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways or chemotherapy. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Objective Response (OR) (confirmed complete response (CR) or partial response (PR)) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 per investigator assessment — Up to 5 years
    Phase 2
  • Progression Free Survival (PFS) by RECIST v1.1 per blinded independent central review (BICR) — Up to 5 years
    Phase 3
  • Overall Survival (OS) — Up to 5 years
    Phase 3

Trial sites (285)

FacilityCityRegionStatus
Local Institution - 0428 Tucson Arizona Not Yet Recruiting
Highlands Oncology Group Springdale Arkansas Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
Local Institution - 0330 Los Angeles California Withdrawn
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
Local Institution - 0317 San Francisco California Not Yet Recruiting
Florida Cancer Specialists - East Cape Coral Florida Recruiting
Florida Cancer Specialists - North St. Petersburg Florida Recruiting
Moffitt Cancer Center Tampa Florida Recruiting
Local Institution - 0326 Atlanta Georgia Not Yet Recruiting
Northside Hospital Atlanta Georgia Recruiting
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia Recruiting
Local Institution - 0433 Chicago Illinois Not Yet Recruiting
Local Institution - 0638 Fort Wayne Indiana Not Yet Recruiting
University of Iowa Iowa City Iowa Recruiting
Local Institution - 0262 Baltimore Maryland Not Yet Recruiting
Maryland Oncology Hematology - Silver Spring Silver Spring Maryland Recruiting
Local Institution - 0471 Boston Massachusetts Withdrawn
Local Institution - 0430 Ann Arbor Michigan Not Yet Recruiting
Local Institution - 0254 Grand Rapids Michigan Not Yet Recruiting
Minnesota Oncology Maple Grove Minnesota Recruiting
Local Institution - 0318 Kansas City Missouri Not Yet Recruiting
Washington University School OF Medicine-Siteman Cancer Center St Louis Missouri Recruiting
University Of Nebraska Medical Center Omaha Nebraska Recruiting
Northwell Health/ RJ Zuckerberg Cancer Center Lake Success New York Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Mineola New York Recruiting
New York Cancer and Blood Specialists Shirley New York Recruiting
Local Institution - 0290 Charlotte North Carolina Not Yet Recruiting
Sanford Fargo Medical Center Fargo North Dakota Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center Columbus Ohio Recruiting
Lehigh Valley Health Network Allentown Pennsylvania Recruiting
Local Institution - 0604 Pittsburgh Pennsylvania Not Yet Recruiting
Sanford Cancer Center Sioux Falls South Dakota Recruiting
Local Institution - 0333 Nashville Tennessee Not Yet Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
Texas Oncology Dallas Fort Worth West (DFWW) - Arlington Cancer Center North Arlington Texas Recruiting
Texas Oncology, PA Austin Texas Recruiting
Baylor College of Medicine Medical Center Houston Texas Recruiting
Texas Oncology - San Antonio San Antonio Texas Recruiting
Local Institution - 0426 Salt Lake City Utah Not Yet Recruiting

+ 245 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221357 on ClinicalTrials.gov ↗ ← All trials in Australia