Recruiting nowPhase 2Randomised
| Registry number | NCT07079631 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 482 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | BioNTech SE |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Biological BNT314
- Drug Pumitamig
- Drug SoC chemotherapy treatment 1
- Drug SoC chemotherapy treatment 2
- Drug Bevacizumab
What it is measuring
Phase I – Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Key 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 histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.
- Have progressed following first-line chemotherapy as specified in the protocol.
- Have not received prior systemic therapy for MSS/pMMR mCRC…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 14 sites. Listed in: Germany, Japan, Spain, United Kingdom, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07079631, registered by BioNTech SE on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.