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

May 18, 2026 updated by: Oncolytics Biotech

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Reference Study ID Number: REO 029 GOBLET
  • Phone Number: +1 (858) 247- 7829
  • Email: reo-029@oncolytics.ca

Study Locations

  • Germany
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69120
        • Nationales Centrum für Tumorerkrankungen Heidelberg
      • Heilbronn, Baden-Wurttemberg, Germany, 74078
        • SLK-Kliniken Heilbronn GmbH
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitätsklinikum Ulm
    • Bavaria
      • Augsburg, Bavaria, Germany, 86150
        • Gemeinschaftspraxis Dr. Med Bernhard Heinreich
      • München, Bavaria, Germany, 81377
        • Klinikum der Universität München
    • Free and Hanseatic City of Hamburg
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 20249
        • Hämatologisch-Onkologische Praxis Eppendorf
      • Hamburg, Free and Hanseatic City of Hamburg, Germany, 22763
        • Asklepios Kliniken Hamburg GmbH
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • Krankenhaus Nordwest
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Germany, 44791
        • St. Josef-Hospìtal, Bochum
    • Rhineland-Palatinate
      • Mainz, Rhineland-Palatinate, Germany, 55131
        • Universitätsmedizin Mainz
    • Saarland
      • Saarbrücken, Saarland, Germany, 66113
        • CaritasKlinikum Saarbrücken St. Theresia
    • Saxony
      • Chemnitz, Saxony, Germany, 09116
        • Klinikum Chemnitz gGmbH
      • Leipzig, Saxony, Germany, 04103
        • Universität Leipzig
    • State of Berlin
      • Berlin, State of Berlin, Germany, 13353
        • Charité Universitätsklinikum Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Cohorts 1-5 Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • In Cohort 4: Prior HIV infection if the CD4+ T cell is <300 cells/µl
  • In Cohort 5: Known low or absent dihydropyrimidine dehydrogenase (DPD) activity.
  • In Cohort 5: Known leptomeningeal disease.
  • In Cohort 5: History of another primary cancer within the last 3 years with the exception of non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Pelareorep
Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion
Drug: Atezolizumab
Atezolizumab 840 mg IV infusion
Other Names:
  • Tecentriq
Drug: Gemcitabine and nab-paclitaxel
Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2)
Other Names:
  • Gemzar
  • Abraxane
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
Drug: Pelareorep
Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion
Drug: Atezolizumab
Atezolizumab 840 mg IV infusion
Other Names:
  • Tecentriq
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
Drug: Pelareorep
Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion
Drug: Atezolizumab
Atezolizumab 840 mg IV infusion
Other Names:
  • Tecentriq
Drug: Trifluridine Tipiracil
Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily
Other Names:
  • Lonsurf
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
Drug: Pelareorep
Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion
Drug: Atezolizumab
Atezolizumab 840 mg IV infusion
Other Names:
  • Tecentriq
Experimental: Cohort 5: Metastatic PDAC 1L
Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab
Drug: Pelareorep
Pelareorep 4.5 x 10^10 TCID50 via 1-hour IV infusion
Drug: Atezolizumab
Atezolizumab 840 mg IV infusion
Other Names:
  • Tecentriq
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) for Cohort 1, 2, 4, and 5
Time Frame: At week 16 (within each cohort)
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
Time Frame: at week 16
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
Time Frame: Cohort 5: From the date of randomization through long term follow up at 2 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years
Time from the first dose date of study treatment to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.
From initiation of treatment to objective progression or death from any cause, whichever occurs first, up to two years
Duration of Response (DOR)
Time Frame: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years
Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.
From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years
Disease Control Rate (DCR)
Time Frame: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years
Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1.
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
Time Frame: From initiation of treatment to disease progression or death from any cause, whichever occurs first, up to two years
ORR, defined as the percentage of patients with a best overall response of complete response [CR] or partial response [PR] according to RECIST v 1.1, and confirmed ORR, defined as the percentage of patients with a CR or PR at two or more consecutive evaluation timepoints.
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
Time Frame: From the date of randomization through long term follow up at 3 years
OS defined as the time from date of first treatment to death from any cause
From the date of randomization through long term follow up at 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oncolytics Biotech

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AIO-Studien-gGmbH
Crolll Gmbh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REO 029
  • 2024-515936-62-00 (Ctis)
  • 2020-003996-16 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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