> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-i-ii-clinical-study-of-lbl-024-in-patients-with-f262a422-b679-4b32-a1d6-32cfee837b07 > Record changed: 2026-10-13 # A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors NCT05170958 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Participants 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Lead sponsor Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Start date 2022-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) Number of sites 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Title and summary **Summary** To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Short title** A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Official title** A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Dates **Completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **First posted** 2021-12-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Registry last updated** 2026-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Primary completion date** 2026-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Start date** 2022-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Size and sites **Participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Planned participants** 396 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Number of sites** 49 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Lead sponsor** Nanjing Leads Biolabs Co.,Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Identifiers **Registry ID** NCT05170958 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **ClinicalTrials.gov ID** NCT05170958 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Outcomes ### Primary outcomes 1. Maximum tolerated dose (MTD) Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study. 2. Dose-limiting toxicities（DLT) Timeframe: Within 3 weeks after receiving the first dose of the test drug During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study. 3. Objective Response Rate (ORR) Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1\. It was used to evaluate the efficacy of LBL-024 in Phase II study. ### Secondary outcomes 1. Adverse events and serious adverse events Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Laboratory examination, physical examination, vital signs and electrocardiogram, etc. 2. Maximum serum concentration (Cmax) Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） To determine the PK profile of LBL-024 3. Immunogenicity Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable) 4. Disease Control Rate(DCR) Timeframe: Visit 30 days after discontinuation of treatment or withdraw from the visit Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response 5. Progression-free survival (PFS) Timeframe: All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit） Defined as the time from random assignment in a clinical trial to disease progression or death from any cause, has recently become an endpoint of considerable interest in the study of new oncology drugs. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 80 Years **Healthy volunteers** No ### Inclusion criteria 1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2. 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase； 3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results: 4. The expected survival time is at least 12 weeks 5. ECOG score is 0-1 6. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered. ### Exclusion criteria 1. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment; 3. medical history of immunodeficiency including positive HIV antibody test; 4. Women who are pregnant or breastfeeding; 5. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Sites - The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaRecruiting - Anhui Provincial HospitalHefei, ChinaRecruiting - The Second Hospital of Anhui Medical UniversityHefei, ChinaRecruiting - Peking Union Medical College HospitalBeijing, ChinaRecruiting - Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting - Beijing Cancer HospitalBeijing, ChinaRecruiting - Chongqing Cancer HospitalChongqing, ChinaRecruiting - Fujian Cancer HospitalFuzhou, ChinaRecruiting - Fujian Medical University Union HospitalFuzhou, ChinaRecruiting - The First Affiliated Hospital of Xiamen UniversityXiamen, ChinaRecruiting - The First Affiliated Hospital,Sun Yat-sen UniversityGuangzhou, ChinaRecruiting - Sun Yat-sen University Cancer CenterGuanzhou, ChinaRecruiting - Guangxi Medical University Cancer Hospital & Guangxi Cancer InstituteNanning, ChinaRecruiting - Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaRecruiting - Sir Run Run Shaw HospitalHangzhou, ChinaRecruiting - Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaRecruiting - Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting - Anyang Tumor HospitalAnyang, ChinaRecruiting - The First Affilated Hospital of Henan University of Science & TechnologyLuoyang, ChinaRecruiting - Henan Cancer HospitalZhengzhou, ChinaRecruiting - The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaRecruiting - Henan Provincial People's HospitalZhengzhou, ChinaRecruiting - Tongji HospitalWuhan, ChinaRecruiting - Wuhan Union Hospital of ChinaWuhan, ChinaRecruiting - Hubei Cancer HospitalWuhan, ChinaRecruiting And 24 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170958) ## Related records ### Drugs (1) - [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md) ### Lead sponsors (1) - [Nanjing Leads Biolabs Co.,Ltd](https://trialight.com/data/company/nanjing-leads-biolabs-co-ltd-dcc320d4-6d8d-4b00-aaec-aafcc1115c44.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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