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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
BioNTech SE
Study ID
NCT07079631
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT314 — BIOLOGICAL
    Intravenous (IV) infusion
  • BNT327 — DRUG
    IV infusion
  • SoC chemotherapy treatment 1 — DRUG
    IV infusion / IV bolus
  • SoC chemotherapy treatment 2 — DRUG
    IV infusion / IV bolus / oral
  • Bevacizumab — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Jul 18, 2025
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
May 31, 2031

Study Design

Enrollment
482 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Part A): BNT314 (escalating dose levels) + BNT327
    Up to 5 dose levels of BNT314. One or two dose levels of BNT327.
  • Experimental: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 1
    BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + BNT327 + SoC combination chemotherapy 1. One selected dose level of BNT327.
  • Experimental: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 2
    BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + BNT327 + SoC combination chemotherapy 2. One selected dose level of BNT327.
  • Experimental: Phase 2 (Part C): BNT314 + BNT327 + SoC chemotherapy 1
    Recommended phase 2 dose of BNT314 + BNT327 + SoC combination chemotherapy 1. One selected dose level of BNT327.
  • Active Comparator: Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1
    Combination of two different SoC therapies
  • Experimental: Phase 2 (Part C): BNT327 + SoC chemotherapy 1
    BNT327 + SoC combination chemotherapy 1. One selected dose level of BNT327.

Primary Outcome Measure

Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period [ Time Frame: Up to 28 days after Day 1, Cycle 1 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511-
START MidwestGrand RapidsMichigan49546-
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer CenterClevelandOhio44195-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By research site
Yale University· New Haven, CTSTART Midwest· Grand Rapids, MICleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center· Cleveland, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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