Recruiting nowPhase 2Randomised
| Registry number | NCT07186842 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 245 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
- Drug BNT329
- Drug CA19-9-targeting monoclonal antibody
What it is measuring
Parts A and B – Occurrence of dose-limiting toxicities within a participant
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.
What this trial is trying to do
The researchers are testing BNT329, given with a monoclonal antibody directed at CA19-9, a marker found on some tumour cells. They are mainly trying to find a dose that people can tolerate, while also measuring whether tumours respond and how long they remain without growing or spreading.
The idea is that targeting CA19-9-expressing tumours could control advanced cancer, but this trial does not compare the treatment with another therapy. Improvement would be shown by tumour responses or longer progression-free time, alongside an acceptable pattern of side effects; safety and dose are the main measures.
Worth knowing: This is primarily a dose-and-safety study with no comparison group, and it includes advanced solid tumours rather than colorectal cancer alone.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
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
The main goal of this study is to evaluate the safety of BNT329 and to identify the best dose of BNT329. This will be done by measuring the number of side effects that participants experience and how severe they are.
The second goal of this study is to evaluate how well BNT329 works. This will be done by measuring the number of participants who respond to the treatment. The length of time where the tumor does not grow or spread will also be measured.
The study will also evaluate how BNT329 moves into, through, and out of the body and how the treatment affects the body.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- 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
All participants and parts
- Have an Eastern Cooperative Oncology Group performance score of 0 to 1
- Have measurable disease per RECIST v1.1, except for ovarian cancer where participants will be evaluated according to Gynecologic Cancer InterGroup criteria.
- Have a life expectancy of ≥3 months in the opinion of the investigator.
- Have adequate organ, coagulation, and hematologic function as defined in the protocol.
Parts A, B, and C:
- Have a histologically confirmed advanced/metastatic tumor type that is known to express CA19-9: PDAC, carcinoma of the bile ducts, invasive urothelial carcinoma of the bladder and urinary tract, colorectal adenocarcinoma, adenocarcinoma of the esophagogastric junction, gastric adenocarcinoma, endometrial carcinoma, and epithelial ovarian cancer (including adenocarcinoma of the fallopian tube and peritoneal epithelial cancer [except mesothelioma]).
- Have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.
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 16 sites. Listed in: Australia, Germany, 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?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT07186842, 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.