NCT07280377

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

A Phase 1 / 2 Multiple-indication Biomarker, Safety, and Efficacy Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Oncolytics Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The overall aim is to assess safety, predictive biomarkers, and preliminary efficacy as assessed by tumor response criteria at week 16 for cohorts1, 2, 3, and 4, and best overall response rate and OS in Cohort 5. If a cohort shows a promising ORR in Stage 1 of the Simon two-stage design, that cohort may be expanded to enroll additional patients (up to 50 patients in Cohorts 1 and 3 , up to 28 patients in Cohort 4, and up to 64 patients in Cohort 5) in an extension phase per predetermined statistical conditions. In addition, either or both arms of Cohort 5 may expand if the data collected in Stage 1 suggest that expansion may help in assessing the potential survival benefit of the investigational therapy(ies). In this study, we hypothesize that treatment with pelareorep will prime the tumor microenvironment (TME) for checkpoint blockade therapy, thereby increasing PD-L1 expression and the number of new T cell clones within the tumor, both of which are associated with increased response to checkpoint blockade.

Conditions

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

Interventions

Type	Name	Description
DRUG	Pelareorep	Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion
DRUG	Atezolizumab	Atezolizumab 840 mg IV infusion
DRUG	Gemcitabine and nab-paclitaxel	Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)
DRUG	Trifluridine Tipiracil	Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily
DRUG	mFOLFIRINOX Treatment Regimen	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

Timeline

• Start date: 2021-10-27
• Primary completion: 2027-07-30
• Completion: 2028-12-31
• First posted: 2025-12-12
• Last updated: 2025-12-12

Locations

15 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study