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

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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