Opening soonPhase 3Randomised
| Registry number | NCT07730489 |
|---|---|
| Recruitment | Opening soon |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 130 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Sichuan Baili Pharmaceutical Co., Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug BL-M07D1
- Drug Regorafenib
- Drug Fruquintinib
- Drug TAS-102
What it is measuring
BICR-assessed Progression-free Survival (PFS)
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 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in patients with advanced colorectal cancer who have HER2 IHC3+ and have failed prior treatment with oxaliplatin, fluorouracil and irinotecan.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- HER2 positive
- Metastatic
- Already 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
Inclusion Criteria
1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. Participants must be ≥18 years and ≤75 years of age on the day of signing the informed consent form;
3. Expected survival time ≥3 months;
4. Patients with histologically or cytologically confirmed metastatic colorectal cancer;
5. Prior failure of standard therapy;
6. Patients suitable for receiving the control regimen treatment;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
9. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
10. Organ function levels must meet the requirements;
11. For premenopausal women of childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the result must exclude pregnancy; they must be non-lactating; all enrolled participants must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.
Exclusion Criteria
1. Have undergone surgical treatment, radical radiotherapy, chemotherapy, immunotherapy, etc. within 4 weeks before the first dose;
2.
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 2 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 NCT07730489, registered by Sichuan Baili Pharmaceutical Co., Ltd. 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.