Overview
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.
Description
This study included phase Ib (safety introduction period) and phase II (randomized controlled extension period).
Phase Ib and Phase II each contain two independent cohorts, Cohort 1 and Cohort 2.
After comprehensive evaluation by the sponsor and investigator, the safety and tolerability of combination therapy in Phase Ib Cohort 1 and Cohort 2 were good, and preliminary efficacy was observed,Participants will be enrolled to conduct the two cohorts of phase II study.The Phase II study design will be adjusted based on results from the Phase Ib study.The population enrolled in Cohort 1 of Phase II will be determined by the results of Cohort 1A and Cohort 1B of Phase Ib.In Cohort 2 of Phase II, eligible participants were randomly assigned to the B1 group and B2 group in a 2: 1 ratio.
Eligibility
Inclusion Criteria:
- 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.
- Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1.
- The expected survival time is at least 12 weeks.
- According to the evaluation of RECIST 1.1 （Response Evaluation Criteria in Solid Tumours），the Participants enrolled have at least one measurable lesion.
- There is adequate organ and bone marrow function,Conforms to laboratory test results.
- 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:
- Participants with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
- Women during pregnancy or lactation.
- Participants with mental illness (impairing understanding or ability to give informed consent),history of Drug abuse, alcoholism or drug addiction.
- participant had a history of severe cardiovascular and cerebrovascular disorder.
- 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.
- patients with active,Or patients who have had and may recur autoimmune diseases.
- patients with active hepatitis B or active hepatitis C.
- History of immunodeficiency including HIV antibody test positive.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
