> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-clinical-study-of-lbl-024-combination-therapy-86e4e228-c1ab-4727-862f-668d70ded13d > Record changed: 2026-10-13 # A Phase Ib/II Clinical Study of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma NCT07791758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Participants 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Lead sponsor Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Start date 2026-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Short title** A Phase Ib/II Clinical Study of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Official title** An Open-label, Multicenter Phase Ib/II Study to Evaluate the Safety and Efficacy of LBL-024 Combination Therapy in Patients With Metastatic Colorectal Carcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Dates **Completion date** 2030-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **First posted** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Primary completion date** 2030-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Start date** 2026-09-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Size and sites **Participants** 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Planned participants** 369 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Lead sponsor** Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Identifiers **Registry ID** NCT07791758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **ClinicalTrials.gov ID** NCT07791758 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Outcomes ### Primary outcomes 1. Objective Response Rate (ORR) Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR). 2. Occurrence of adverse event (AE) and serious adverse event (SAE) Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy) Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 Combination Therapy will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study. ### Secondary outcomes 1. Disease Control Rate(DCR） Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) Percentage of participants achieving complete response (CR) or partial response (PR) and stable disease (SD) after treatment. 2. Duration of Response(DOR） Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) DoR (per RECIST 1.1) is defined as the time from the date for first documented response of complete response (CR) or partial response (PR) to the date of first documented of disease progression or death, whichever occurs first. 3. Progression-free Survival(PFS) Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause. 4. Overall survival (OS) Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) Time from randomization to death for any reason in a clinical trial. 5. Cmax Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) Maximum drug concentration in plasma after administration. 6. Tmax Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) After administration,Time to reach maximum drug concentration in plasma. 7. Immunogenicity Timeframe: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy) The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.Immunogenicity refers to the performance that can elicit an immune response. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Sites - Sun Yat-sen University Cancer CenterGuangzhou, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07791758) ## Related records ### Drugs (5) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) - [Fruquintinib](https://trialight.com/data/asset/fruquintinib-e15c1522-cabe-4f7b-a918-3ca55e1ef88a.md) - [Oxaliplatin](https://trialight.com/data/asset/oxaliplatin-bd23604a-83f3-4d4c-8330-93f435fc2a0b.md) ### Collaborators (1) - Sun Yat-Sen University Cancer Center ### Lead sponsors (1) - [Nanjing Leads Biolabs Co.,Ltd](https://trialight.com/data/company/nanjing-leads-biolabs-co-ltd-dcc320d4-6d8d-4b00-aaec-aafcc1115c44.md) ### Conditions (2) - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (5) - [FLT1](https://trialight.com/data/target/flt1-2cfcec95-3fff-5be9-8423-701697547fa0.md) - [FLT4](https://trialight.com/data/target/flt4-c94058e2-ff1e-553b-92a5-8e7ee9305a80.md) - [KDR](https://trialight.com/data/target/kdr-4ab08263-0477-533e-ac3f-96e20d343c4b.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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