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

NCT07280377 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2026-05-19

No results posted yet for this study

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

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

Interventions

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

Sponsors & Collaborators

  • Crolll Gmbh

    collaborator OTHER

  • AIO-Studien-gGmbH

    collaborator OTHER

  • Oncolytics Biotech

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2027-07-30
Completion
2028-12-31
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07280377 on ClinicalTrials.gov