Recruiting nowPhase 2Randomised
What this trial is trying to do
The trial is testing LBL-024, an immune-checkpoint drug that targets TIGIT, together with established colorectal-cancer treatments such as chemotherapy, bevacizumab or fruquintinib. The idea is that blocking TIGIT may help immune cells attack the cancer more effectively when combined with these drugs.
The researchers are asking whether these combinations can produce tumour shrinkage in metastatic colorectal cancer, measured by objective response rate (the proportion of patients whose tumours shrink). A better result would mean more patients responding, but this trial is not measuring longer survival as its main outcome.
Worth knowing: This is an early-phase Ib/II trial with no stated comparison group, and tumour response is a short-term measure rather than proof of longer life or better quality of life.
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 | NCT07791758 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | randomised, open label |
| Taking part | 369 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | Nanjing Leads Biolabs Co.,Ltd |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug LBL-024 for Injection
- Drug Bevacizumab injection
- Drug Oxaliplatin injection
- Drug Capecitabine tablets
- Drug Fruquintinib Capsules
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.
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 study is an open-label, multi-center Phase Ib/II clinical trial evaluating the safety and efficacy of LBL-024 in combination with other drugs for the treatment of metastatic colorectal carcinoma (mCRC), aiming to evaluate the safety and efficacy of LBL-024 in combination with other drugs in the treatment of mCRC patients.
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
Inclusion Criteria
1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent.
2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.
6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
7. Male of childbearing potential and Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug.
Exclusion Criteria
1. Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
2. Women during pregnancy or lactation.
3. Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.
4.
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 10 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 NCT07791758, registered by Nanjing Leads Biolabs 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.