NCT07079631

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 482 (estimated)
• Sponsor: BioNTech SE · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 combination with the usual SoC chemotherapy treatment, can shrink tumors or slow down their growth. The study consists of a screening period, a treatment period, a safety follow-up period, and a long-term survival follow-up period. The sponsor plans to proactively assess participant safety on a regular basis for the duration of the study according to a predefined internal review committee. In addition, an independent data monitoring committee will be developed to provide medical oversight over Part C of the study. Participants in the study will continue to receive treatment until their disease worsens, they can no longer tolerate the treatment, or the study ends. They are expected to be on treatment for about of 6-10 months on average. After that, they will be monitored for their survival and any potential long-term side effects even after they stop participating in the study.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
BIOLOGICAL	BNT314	Intravenous (IV) infusion
DRUG	BNT327	IV infusion
DRUG	SoC chemotherapy treatment 1	IV infusion / IV bolus
DRUG	SoC chemotherapy treatment 2	IV infusion / IV bolus / oral
DRUG	Bevacizumab	IV infusion

Timeline

• Start date: 2025-07-18
• Primary completion: 2030-12-01
• Completion: 2031-05-01
• First posted: 2025-07-23
• Last updated: 2026-04-17

Locations

14 sites across 5 countries: United States, Germany, Japan, Spain, United Kingdom

Regulatory

• FDA-regulated drug study