Recruiting nowPhase 2Randomised
| Registry number | NCT07133750 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Biotheus Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug PM8002
- Drug Chemotherapy Regimen 1
- Drug Chemotherapy Regimen 2
- Drug Chemotherapy Regimen 3
What it is measuring
Objective response rate (ORR)
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 PM8002 (BNT327), a bispecific antibody that blocks PD-L1, an immune “off” signal, and VEGF, which helps tumours form blood vessels, alongside chemotherapy as first treatment for metastatic colorectal cancer. The trial asks whether this combination is safe and can shrink tumours in cancers that are MSS or MSI-L/pMMR.
The idea is that releasing immune suppression and reducing tumour blood supply could add to chemotherapy’s effect. The main test is objective response rate—the proportion of patients whose tumours shrink—not whether patients live longer or go longer before the cancer grows.
Worth knowing: This is a phase 2 trial with no comparator listed, and its main outcome is tumour response rather than survival; it is also limited to first-line MSS or MSI-L/pMMR disease.
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
PM8002 (BNT327) is a bispecific antibody targeting PD-L1 and VEGF. This is a phase II trial to evaluate the efficacy and safety of PM8002 in combination with chemotherapy in first line MSS or MSI-L/pMMR metastatic colorectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
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
1. Signed informed consent form before any trial-related processes.
2. Age ≥ 18 years male or female.
3. Histologically or cytologically confirmed metastatic colorectal cancer (stage IV, UICC/AJCC staging system) that is not suitable for or cannot be radically resected surgically.
4. Participants must not have dMMR or MSI-H.
5. No prior systemic anti-tumor therapy for metastatic colorectal cancer.
6. have adequate organ function.
7. The investigator confirms at least one measurable lesion according to RECIST v1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed.
8. The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1.
Key Exclusion Criteria
1. Received the following treatments or medications prior to starting study treatment:
1. Received palliative local therapy, non-specific immunomodulatory therapy, or chineses herbal therapy with an anti-tumor indication within 14 days prior to study treatment.
2. Treatment with systemic glucocorticoids (prednisone >10 mg/day or equivalent dose of other glucocorticoids) or other immunosuppressive agents within 14 days prior to initiation of study treatment.
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 11 sites. Listed in: China.
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 NCT07133750, registered by Biotheus Inc. 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.