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

NCT07280377 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: REO 0292024-515936-62-002020-003996-16
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5

  Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1

  At week 16 (within each cohort)

• Disease Control Rate (DCR) - Cohort 3

  DCR (complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) assessed by the investigators according to RECIST v 1.1.

  at week 16

• Overall Survival (OS) - Cohort 5

  OS is defined as the time from date of first treatment to death from any cause

  Cohort 5: From the date of randomization through long term follow up at 2 years

Secondary Outcomes (5)

• Progression Free Survival (PFS)

  From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years

• Duration of Response (DOR)

  From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

• Disease Control Rate (DCR)

  From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

• Overall Response Rate (ORR) - Cohort 1-4

  From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years

• Overall Survival (OS) - Cohort 1-4

  From the date of randomization through long term follow up at 3 years

Study Arms (5)

Cohort 1: Metastatic Pancreatic Cancer 1L

EXPERIMENTAL

Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel

Drug: Pelareorep; Drug: Atezolizumab; Drug: Gemcitabine and nab-paclitaxel

Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR)

EXPERIMENTAL

Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab

Drug: Pelareorep; Drug: Atezolizumab

Cohort 3: Metastatic Colorectal Cancer 3L

EXPERIMENTAL

Patients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil

Drug: Pelareorep; Drug: Atezolizumab; Drug: Trifluridine Tipiracil

Cohort 4: Metastatic Unresectable Anal Cancer >/=2L

EXPERIMENTAL

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

Drug: Pelareorep; Drug: Atezolizumab

Cohort 5: Metastatic PDAC 1L

EXPERIMENTAL

Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab

Drug: Pelareorep; Drug: Atezolizumab; Drug: mFOLFIRINOX Treatment Regimen

Interventions

Pelareorep DRUG

Pelareorep 4.5 x 10\^10 TCID50 via 1-hour IV infusion

Cohort 1: Metastatic Pancreatic Cancer 1L; Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR); Cohort 3: Metastatic Colorectal Cancer 3L; Cohort 4: Metastatic Unresectable Anal Cancer >/=2L; Cohort 5: Metastatic PDAC 1L

Atezolizumab DRUG

Atezolizumab 840 mg IV infusion

Also known as: Tecentriq

Cohort 1: Metastatic Pancreatic Cancer 1L; Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR); Cohort 3: Metastatic Colorectal Cancer 3L; Cohort 4: Metastatic Unresectable Anal Cancer >/=2L; Cohort 5: Metastatic PDAC 1L

Gemcitabine and nab-paclitaxel DRUG

Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)

Also known as: Gemzar, Abraxane

Cohort 1: Metastatic Pancreatic Cancer 1L

Trifluridine Tipiracil DRUG

Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily

Also known as: Lonsurf

Cohort 3: Metastatic Colorectal Cancer 3L

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

Cohort 5: Metastatic PDAC 1L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ECOG performance status of 0 or 1
• Have measurable lesions per RECIST v1.1
• Patients must have adequate hematological, renal, and hepatic function
• Have recovered to ≤grade 1 or baseline for all adverse events (AEs) due to previous therapies or surgeries.
• For female patients of childbearing potential and male patients with partners of childbearing potential, agreement to use a highly-effective form(s) of contraception and to continue its use for 6 months after the last dose of study drug.

You may not qualify if:

• Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment.
• Received previous treatment with immune checkpoint inhibitors
• Uncontrolled or severe cardiac disease
• Active, uncontrolled infections
• Symptomatic brain metastasis
• Interstitial lung disease with symptoms or signs of activity.
• Autoimmune disease that has required systemic treatment in the past 2 years with disease modifying agents, corticosteroids, or immunosuppressive drugs.
• A seizure disorder that requires pharmacotherapy.
• Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation.
• A non-healing wound, non-healing ulcer, or non-healing bone fracture within 4 weeks prior to the start of study drug.
• Women who are pregnant or breastfeeding.
• A diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy
• Any vaccine within 28 days prior to first treatment or during the first cycle of study treatment.
• In Cohort 1, 2, 3, 4: Life expectancy less than 3 months
• In Cohort 1, 2, 3: known active Hepatitis B (HBV) or Hepatitis C (HCV) infection that requires anti-viral treatment.

Sponsors & Collaborators

• Oncolytics Biotech: lead
• Crolll Gmbh: collaborator
• AIO-Studien-gGmbH: collaborator

Study Sites (15)

Nationales Centrum für Tumorerkrankungen Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

SLK-Kliniken Heilbronn GmbH

Heilbronn, Baden-Wurttemberg, 74078, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Gemeinschaftspraxis Dr. Med Bernhard Heinreich

Augsburg, Bavaria, 86150, Germany

RECRUITING

Klinikum der Universität München

München, Bavaria, 81377, Germany

RECRUITING

Hämatologisch-Onkologische Praxis Eppendorf

Hamburg, Hamburg, 20249, Germany

RECRUITING

Asklepios Kliniken Hamburg GmbH

Hamburg, Hamburg, 22763, Germany

RECRUITING

Krankenhaus Nordwest

Frankfurt am Main, Hesse, 60488, Germany

RECRUITING

St. Josef-Hospìtal, Bochum

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Caritasklinikum Saarbrücken St. Theresia

Saarbrücken, Saarland, 66113, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Saxony, 09116, Germany

RECRUITING

Universität Leipzig

Leipzig, Saxony, 04103, Germany

RECRUITING

Charité Universitätsklinikum Berlin

Berlin, State of Berlin, 13353, Germany

RECRUITING

MeSH Terms

Interventions

reolysin; atezolizumab; Gemcitabine; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; trifluridine tipiracil drug combination

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Reference Study ID Number: REO 029 GOBLET

CONTACT

+1 (858) 247- 7829; reo-029@oncolytics.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 12, 2025
• Study Start: October 27, 2021
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

DE (15)