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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from May 2031 to Dec 2032 Interventions: BNT314 (Biological), BNT327 (Drug), Bevacizumab (Drug), SoC chemotherapy treatment 1 (Drug), SoC chemotherapy treatment 2 (Drug) to BNT314 (Biological), Bevacizumab (Drug), Pumitamig (Drug), SoC chemotherapy treatment 1 (Drug), SoC chemotherapy treatment 2 (Drug) · Eligibility criteria expanded, about 32 words · Secondary endpoints revised (18) · 2 morev7 Show 5 more changesShow less
    • Interventions: BNT314 (Biological), BNT327 (Drug), Bevacizumab (Drug), SoC chemotherapy treatment 1 (Drug), SoC chemotherapy treatment 2 (Drug) to BNT314 (Biological), Bevacizumab (Drug), Pumitamig (Drug), SoC chemotherapy treatment 1 (Drug), SoC chemotherapy treatment 2 (Drug)
    • Eligibility criteria expanded, about 32 words
    • Secondary endpoints revised (18)
    • Study description expanded, about 114 words
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  2. Study sites: 13 to 14v6
  3. Study sites: 7 to 13v5
  4. Study sites: 2 to 7v4
  5. Study sites: 1 to 2v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 2025 to Jul 18, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2025 to Jul 18, 2025
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BioNTech SE
49 trials monitored
See 3 trials at risk
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
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).
Trial Details
NCT Number NCT07079631
Lead Sponsor BioNTech SE
Collaborators: Genmab
Conditions Metastatic Colorectal Cancer
Enrollment 482 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov