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

RecruitingPhase 2

An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Oncolytics Biotech · Participants: 60 · Started: Apr 30, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07446322

Locations in the U.S.

AlabamaCentral Alabama Research, Homewood
CaliforniaClinical Research Advisors (Beverly Hills), Beverly Hills
Clinical Research Advisors (Encino), Encino
Clinical Research Advisors (Korea Town), Koreatown
Clinical Research Advisors (Downtown LA), Los Angeles
Clinical Research Advisors (West Hollywood), Los Angeles
Clinical Research Advisors (West Covina), West Covina
FloridaMoffitt Cancer Center, Tampa
GeorgiaEmory Winship Cancer Institute, Atlanta
IdahoBeacon Cancer Center, Post Falls
IllinoisNorthwestern Memorial Hospital, Chicago
IndianaCommunity Health Network, Indianapolis (Not yet recruiting)
MichiganKarmanos Cancer Institute, Detroit
MissouriWashington University School of Medicine, St Louis
New JerseySummit Health Cancer Center, Florham Park
Rutgers Cancer Institute, New Brunswick
OhioGabrail Cancer Center, Canton

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.