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
← catalyst calendarNCT07079631 · readout ≤ 1,595 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →. With Genmab.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
482estimated
Sites
14
Countries
Germany, Japan, Spain +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-07-18 | actual | When the study began enrolling |
| Primary completion | Dec 2030 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-01 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Metastatic Colorectal Cancer
Interventions
- Biological: BNT314
- Drug: Pumitamig — also filed as BNT327, PM8002
- Drug: SoC chemotherapy treatment 1
- Drug: SoC chemotherapy treatment 2
- Drug: Bevacizumab
Primary outcomes
what the primary-completion date above is the date OFPhase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period
measured Up to 28 days after Day 1, Cycle 1
Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
measured From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of investigational medicinal product (IMP)
Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
measured From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort
measured Up to 42 days after Day 1, Cycle 1
Phase I - Part B: Occurrence of TEAEs and TRAEs
measured From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
measured From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Objective response rate (ORR)
measured From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase II - Part C: Progression free survival
measured From the time of initiation of the first dose of IMP to end of study, up to 57 months
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