LBL-024 combo therapy for metastatic colorectal cancer in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multi-center Phase Ib/II study assesses the safety and preliminary effectiveness of LBL-024 in combination with other therapies in patients with metastatic colorectal cancer. Phase Ib focuses on safety and tolerability across two cohorts, while Phase II expands to randomized cohorts to further evaluate efficacy and refine the regimen. The design allows adjustments based on Phase Ib results, with Cohort 2 participants randomized 2:1 between two treatment arms in Phase II. Eligible patients will have measurable disease, adequate organ function, and ECOG 0-1, and must meet other protocol requirements.

Why it matters

Who can join: the full rules

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. participant had a history of severe cardiovascular and cerebrovascular disorder.
5. Subjects who received a live vaccine within 4 weeks prior to the first dose or are scheduled to receive a live vaccine during the study treatment period and within 4 weeks after the last dose.
6. patients with active,Or patients who have had and may recur autoimmune diseases.
7. patients with active hepatitis B or active hepatitis C.
8. History of immunodeficiency including HIV antibody test positive.
9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• The Sixth Affiliated Hospital Sun Yat-sen University
  Guangzhou, Guangdong, China Not yet recruiting
• The First Affiliated Hospital of Guilin Medical University
  Guilin, Guangxi, China Not yet recruiting
• Guangxi Medical University Cancer Hospital
  Nanning, Guangxi, China Not yet recruiting
• The First Affiliated Hospital of Henan University of Science & Technology
  Luoyang, Henan, China Not yet recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Not yet recruiting

Study contacts

• Principal investigator: Ruihua Xu — Sun Yat-Sen University Cancer Center
• Study coordinator: Ruihua Xu
• Email: liulei@leadsbiolabs.com
• Phone: 025-83378099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.