A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With BNT327 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 immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic therapy before for their cancer.
Description
The main study goals are as follows: * Part A (Phase 1, safety run-in, dose escalation): To see if BNT314 in combination with BNT327 is safe for participants and to investigate if the administration of treatment that can be given safely, without causing severe side effects in participants. * Part B (Phase 1, dose optimization): To see if BNT314 in combination with BNT327 and standard of care (SoC) chemotherapy is safe for participants and to find out the right dose of BNT314 that can be used in Part C. * Part C (Phase 2, randomization against SoC): To see whether BNT314 and BNT327, given in c…
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
- DrugBNT327
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