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

Study Identifier:
BNT314-02
CT.gov Identifier:
NCT07079631
EudraCT Identifier:
202552000000
EU Trial (CTIS) Number:
2025-521768-36-00
Study Contact Information:
N/A
Recruiting

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Study 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).

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Bowel (Colorectal)
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Phase 1 (Part A): BNT314 (escalating dose levels) + BNT327
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  • Drug: Drug: BNT327
  • Drug: Experimental: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 1
  • Drug: One selected dose level of BNT327.
  • Drug: Biological: BNT314
  • Drug: Drug: SoC chemotherapy treatment 1
  • Drug: Experimental: Phase 1 (Part B): BNT314 + BNT327 + SoC chemotherapy 2
  • Drug: Drug: SoC chemotherapy treatment 2
  • Drug: Experimental: Phase 2 (Part C): BNT314 + BNT327 + SoC chemotherapy 1
  • Drug: Active Comparator: Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1
  • Drug: Drug: Bevacizumab
  • Drug: Experimental: Phase 2 (Part C): BNT327 + SoC chemotherapy 1
  • Drug: 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.
  • Drug: 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.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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 tumor tissue (less than 2 years prior treatment).
    • * Have Eastern Cooperative Oncology Group Performance Status of 0 or 1.
    • * Have a life expectancy of ≥12 weeks.
    • * Have an adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol.
    • * Have had an adequate previous treatment washout period before randomization/enrollment as defined in the protocol.
    • Inclusion criteria applicable to only protocol-specific cohorts:
    • * Have received at least two previous lines of therapy for metastatic disease.
    • * Have progressed following first-line chemotherapy as specified in the protocol.
    • * Have not received prior systemic therapy for MSS/pMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.
    • Other cohort-specific inclusion criteria apply.
    • Key
    Exclusion criteria
    • * Confirmed MSI-H/deficient mismatch repair mCRC (per FDA/CE approved test or based on local testing).
    • * Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or immunotherapy.
    • * Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD[L]-1)/vascular endothelial growth factor bispecific antibody.
    • * Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Sreenivasa Chandana
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)
    Location
    START Madrid, Spain (CIOCC)
    Madrid, Spain, 28050
    Investigator
    Irene Moreno
    Status
    Recruiting
    Condition(s) Treated at Site
    Bowel (Colorectal)