Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer Metastatic | — | UNRESOLVED | — |
| Pancreatic Cancer Metastatic | — | UNRESOLVED | — |
| Squamous Cell Carcinoma of the Anus Stage Unspecified | — | UNRESOLVED | — |
| Unresectable Pancreatic Carcinoma | Pancreatic Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab | ALIAS |
| Gemcitabine and nab-paclitaxel | Drug | — | UNRESOLVED |
| mFOLFIRINOX Treatment Regimen | Drug | — | UNRESOLVED |
| Pelareorep | Drug | — | UNRESOLVED |
| Trifluridine Tipiracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1: Metastatic Pancreatic Cancer 1L
- description
- Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel
- interventionNames
- Drug: Pelareorep
- Drug: Atezolizumab
- Drug: Gemcitabine and nab-paclitaxel
- type
- EXPERIMENTAL
- label
- Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR)
- description
- Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab
- interventionNames
- Drug: Pelareorep
- Drug: Atezolizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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