Recruiting nowPhase 1
What this trial is trying to do
The trial is testing how safely people with advanced gastrointestinal and other solid tumours can receive BL-B01D1, starting with dose increases to find the dose-limiting toxicities (side effects that prevent further dose increases). A further group will receive the selected dose to help determine the dose for later studies, while researchers also collect early information on drug levels, immune reactions and possible tumour effects.
There is no comparison treatment: the immediate aim is to find a dose that can be given safely and tolerated well enough for future trials. Any signs that the cancer shrinks or remains controlled are exploratory here, not evidence that BL-B01D1 improves survival or delays progression.
Worth knowing: This small, non-randomised phase 1 trial is designed primarily to assess safety and dose, so it cannot establish whether the drug benefits patients.
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.
| Registry number | NCT05262491 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 96 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-B01D1
What it is measuring
Phase Ia: Dose limiting toxicity (DLT)
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 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1.
In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
In addition, the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 in patients with locally advanced or metastatic gastrointestinal tumor and other solid tumor will be evaluated.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Locally advanced
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. Participants must sign the informed consent form voluntarily and follow the plan requirements.
2. No gender limit.
3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib).
4. Expected survival time ≥ 3 months.
5. Patients with locally advanced or metastatic triple-negative breast cancer or other solid tumors who have been diagnosed histopathologically and/or cytologically as failing standard therapy, or who are not eligible for standard therapy at this stage, and who are inoperable.
6. Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 3 years (TROP2 protein expression in tumor pathological tissue to explore the correlation between TROP2 protein expression and BL-M02D1 validity index); If subjects are unable to provide tumor tissue samples, they will be admitted after evaluation by the investigator if other admission criteria are met.
7. Participants must have at least one assessable lesion as defined by RECIST V1.1.
8. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
9.
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 6 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?
- 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 NCT05262491, 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.