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Clinical Trials in the USA / NCT07446322
Recruiting Phase 2

FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

NCT07446322 · tracked via the Priya Life Science USA tracker
Sponsor
Oncolytics Biotech
Phase
Phase 2
Started
2026-04-30
Last updated
2026-09-16

Condition(s) studied

Ras-mutated Metastatic Colorectal CancermCRCMSS Metastatic Colorectal Cancer

Investigational drug(s) / intervention(s)

BevacizumabFOLFIRIPelareorep

Bevacizumab: Bevacizumab (5 mg/kg) IV infusion

FOLFIRI: irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion

Pelareorep: pelareorep 4.5 x 10\^10 TCID50 IV infusion

Study summary

This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Histologically confirmed cancer of the colon or rectum with documented metastasis * Measurable disease per RECIST v. 1.1 * Not candidates for curative surgery or curative radiation * Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin * Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab * Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method * Tumor confirmed to harbor a known RAS mutation per a standard local testing method * ECOG performance status of 0 or 1 * Patients must have adequate hematological, renal, and hepatic function * Female patients of childbearing potential must have a negative pregnancy test * Life expectancy of at least 6 months Exclusion Criteria: * Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment * Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment * Prior treatment with irinotecan * Symptomatic brain metastases * Active autoimmune disease * Receiving immunosuppressive or myelosuppressive medications * Active, uncontrolled infections * Known HIV infection or active hepatitis B or C that requires anti-viral treatment * History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ * History of allergy or known hypersensitivity to any of the study drugs, study drug classes, * Uncontrolled or severe cardiac disease * Received any vaccine within 28 days prior to first study treatment

Primary outcome measure(s)

Trial sites (15)

FacilityCityRegionStatus
Central Alabama Research Homewood Alabama Recruiting
Clinical Research Advisors (Beverly Hills) Beverly Hills California Recruiting
Clinical Research Advisors (Encino) Encino California Recruiting
Clinical Research Advisors (Korea Town) Koreatown California Recruiting
Clinical Research Advisors (Downtown LA) Los Angeles California Recruiting
Clinical Research Advisors (West Hollywood) Los Angeles California Recruiting
Clinical Research Advisors (West Covina) West Covina California Recruiting
Emory Winship Cancer Institute Atlanta Georgia Recruiting
Beacon Cancer Center Post Falls Idaho Recruiting
Community Health Network Indianapolis Indiana Not Yet Recruiting
Karmanos Cancer Institute Detroit Michigan Recruiting
Washington University School of Medicine St Louis Missouri Not Yet Recruiting
Summit Health Cancer Center Florham Park New Jersey Recruiting
Rutgers Cancer Institute New Brunswick New Jersey Recruiting
Gabrail Cancer Center Canton Ohio Recruiting

On this site

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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 NCT07446322 on ClinicalTrials.gov ↗ ← All trials in the USA