drugset / Trial / NCT07280377
A Study in Advanced or Metastatic Gastrointestinal Cancers Exploring Treatment Combinations With Pelareorep and Atezolizumab
Phase 1/2
Active not recruiting
122 enrolled
Oncolytics Biotech
AIO-Studien-gGmbH · collabCrolll Gmbh · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-10-27
- Primary completion
- 2027-07-30
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 840 mg | Intravenous |
| Subject | Pelareorep | Other / unclassified | 4.5e+10 unknown | Intravenous |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Background | Irinotecan | Small molecule | 150 mg/m2 | Intravenous |
| Background | Leucovorin | Small molecule | 400 mg/m2 | Intravenous |
| Background | Oxaliplatin | Small molecule | 85 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 125 mg/m2 | — |
| Background | Trifluridine/tipiracil | Unknown | 35 mg/m2 | Oral |
| Background | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |