A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

Sponsor
Oncolytics Biotech
Study ID
NCT07280377
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Anal Cancer Metastatic
  • Pancreatic Cancer Metastatic
  • Squamous Cell Carcinoma of the Anus Stage Unspecified
  • Unresectable Pancreatic Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pelareorep — DRUG
    Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion
  • Atezolizumab — DRUG
    Atezolizumab 840 mg IV infusion
  • Gemcitabine and nab-paclitaxel — DRUG
    Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)
  • Trifluridine Tipiracil — DRUG
    Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily
  • mFOLFIRINOX Treatment Regimen — DRUG
    mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care

Study Details

This is an open-label, phase 1/2, multiple-indication platform study to explore safety, potential predictive immune-related biomarkers, and early efficacy (as measured by objective response rate \[ORR; Cohorts 1,2, 4,and 5\] and disease control rate \[DCR; Cohort 3\]) in patients with advanced or metastatic gastrointestinal (GI) tumors. Cohorts 1-4 are not randomized; however, Cohort 5 is comprised of two treatment arms to which patients are randomized in a 1:1 ratio.

Key Dates

First listed
Dec 12, 2025
Start date
Oct 27, 2021
Status verified
May 2026
Primary completion
Jul 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
122 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Metastatic Pancreatic Cancer 1L
    Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel
  • Experimental: Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR)
    Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab
  • Experimental: Cohort 3: Metastatic Colorectal Cancer 3L
    Patients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil
  • Experimental: Cohort 4: Metastatic Unresectable Anal Cancer >/=2L
    Patients with \>/= 2L locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA) of viral or non-viral origin after prior systemic chemotherapy: Pelareorep and atezolizumab
  • Experimental: Cohort 5: Metastatic PDAC 1L
    Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab

Primary Outcome Measure

Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5 [ Time Frame: At week 16 (within each cohort) ]

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