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

NCT07446322

RecruitingPhase 2

Sponsor: Oncolytics Biotech

Conditions: Ras-mutated Metastatic Colorectal Cancer, mCRC, MSS Metastatic Colorectal Cancer

Interventions: Bevacizumab, FOLFIRI, Pelareorep

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (13)

Homewood, Alabama, United States
Beverly Hills, California, United States
Encino, California, United States
Koreatown, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
West Covina, California, United States
Atlanta, Georgia, United States
Indianapolis, Indiana, United States
St Louis, Missouri, United States
Florham Park, New Jersey, United States
New Brunswick, New Jersey, United States
Canton, Ohio, United States