Recruiting
Phase 2

FOLFIRI, Bevacizumab, Pelareorep

Sponsor:

Oncolytics Biotech

Code:

NCT07446322

Conditions

Ras-mutated Metastatic Colorectal Cancer

mCRC

MSS Metastatic Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bevacizumab

FOLFIRI

Pelareorep

Study Details

Brief 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.

Conditions

Ras-mutated Metastatic Colorectal Cancer

mCRC

MSS Metastatic Colorectal Cancer

Study ID

NCT07446322

Start date

Apr 30, 2026

Status verified date

Aug, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Aug 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

experimental: Arm B

Interventions

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

Primary outcome measure

  • Overall Response Rate (ORR) [ Time Frame: At week 8 ]

Central Contacts and Locations

Central contacts

Name: Reference Study ID Number: REO 033

+1 (858) 247-7829REO-033@oncolytics.com

Locations

Central Alabama Research

Recruiting

Homewood, Alabama, United States, 35209

Contacts

Lorie Syzmela

205-949-1907lszymela@centralalabamaresearch.com

Clinical Research Advisors (Beverly Hills)

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Ali Muhammad, MD, MBA

310-432-8934AMuhammad@bhcancercenter.com

Clinical Research Advisors (Encino)

Recruiting

Encino, California, United States, 91316

Clinical Research Advisors (Korea Town)

Recruiting

Koreatown, California, United States, 90020

Clinical Research Advisors (Downtown LA)

Recruiting

Los Angeles, California, United States, 90033

Clinical Research Advisors (West Hollywood)

Recruiting

Los Angeles, California, United States, 90048

Clinical Research Advisors (West Covina)

Recruiting

West Covina, California, United States, 91790

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Cheyenne Schneider

813-745-5166Cheyenne.Schneider@moffitt.org

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30302

Contacts

Armand Fernandez

404-778-8201armand.falqueza.fernandez@emory.edu

Beacon Cancer Center

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Kaitie Bean

208-755-2804kbean@yourbeaconclinic.com

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

clinicaltrials@northwestern.edu

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Mindy Thacker

317-621-4300MThacker@ecommunity.com

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Taylor Brewer

brewert@karmanos.org

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Justin Stout

314-362-2582justinjstout@wustl.edu

Summit Health Cancer Center

Recruiting

Florham Park, New Jersey, United States, 07932

Contacts

Michelle Mackenzie

973-436-1755mmackenzie@summithealth.com

Rutgers Cancer Institute

Recruiting

New Brunswick, New Jersey, United States, 08901

Contacts

Christian F Misdary

732-735-3626cm1344@cinj.rutgers.edu

Gabrail Cancer Center

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-417-8231recruitment@gabrailcancercenter.com

Kimberly Roby

330-492-3345recruitment@gabrailcancercenter.com

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Ohio State University

Recruiting

Colombus, Ohio, United States, 43210

More Information

Sponsor

Oncolytics Biotech

Last update posted

Oct 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Oncolytics Biotech on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.