RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Clinical Trial of LBL-024 Combination Drug in Patients With Metastatic Colorectal Carcinoma

Sponsor: Nanjing Leads Biolabs Co.,Ltd • ClinicalTrials.gov ID: NCT07791758

Registry updated: 2026-10-16

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Description

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.

Interventions

LBL-024 for Injection (Drug)
intravenous infusion.
Bevacizumab injection (Drug)
intravenous infusion.
Oxaliplatin injection (Drug)
intravenous infusion.
Capecitabine tablets (Drug)
Oral.
Fruquintinib Capsules (Drug)
Oral.

Eligibility criteria

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.

Conditions

Metastatic Colorectal Carcinoma

Locations

Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
The Sixth Affiliated Hospital Sun Yat-sen University — Guangzhou, Guangdong, China
The First Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China
Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China
The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China
The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
Shandong Cancer Hospital — Jinan, Shandong, China
Shanghai GoBroad Cancer Hospital — Shanghai, Shanghai Municipality, China
Sichuan Cancer Hospital — Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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