A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer
BioNTech SE
Summary
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).
Description
Participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC with progressive disease to the metastatic first line (1L) setting (Parts B and C) and beyond (Part A) as well as treatment-naïve (for Part B) are eligible to participate in the study. The main study goals are as follows: * Part A (Phase 1, safety run-in, dose escalation): To see if BNT314 in combination with pumitamig can be given safely, without causing severe side effects in participants. * Part B (Phase 1, dose optimization): To see if BNT314 in combination with pumitamig and standard of care (SoC) chem…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Have unresectable histologically confirmed adenocarcinoma of the colon or rectum. * Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing. * Have measurable disease defined by RECIST v1.1. * Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival…
Interventions
- BiologicalBNT314
Intravenous (IV) infusion
- DrugPumitamig
IV infusion
- DrugSoC chemotherapy treatment 1
IV infusion / IV bolus
- DrugSoC chemotherapy treatment 2
IV infusion / IV bolus / oral
- DrugBevacizumab
IV infusion
Locations (14)
- Yale UniversityNew Haven, Connecticut
- START MidwestGrand Rapids, Michigan
- Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer CenterCleveland, Ohio
- The University of Texas MD Anderson Cancer CenterHouston, Texas
- Hämatologisch-Onkologische Praxis Eppendorf - HOPEHamburg
- Asklepios Tumorzentrum HamburgHamburg