A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Key facts

Study ID

NCT05170958

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

396

Starts

2022-01-06

Expected to finish

2026-12-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
• 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；
• Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
• The expected survival time is at least 12 weeks
• ECOG score is 0-1
• 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.

You may not qualify if…

• Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
• Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
• medical history of immunodeficiency including positive HIV antibody test;
• Women who are pregnant or breastfeeding;
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Where it is running

• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (enrolling)
• The First Affiliated Hospital,Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Sun Yat-sen University Cancer Center — Guanzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute — Nanning, Guangxi, China (enrolling)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (enrolling)
• Sir Run Run Shaw Hospital — Hangzhou, Hangzhou, China (enrolling)
• Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Anyang Tumor Hospital — Anyang, Henan, China (enrolling)
• The First Affilated Hospital of Henan University of Science & Technology — Luoyang, Henan, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Tongji Hospital — Wuhan, Hubei, China (enrolling)
• Wuhan Union Hospital of China — Wuhan, Hubei, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (enrolling)
• Nanjing First Hospital — Nanjing, Jiangsu, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• The Second Affiliated Hospital Nanchang University — Nanchang, Jiangxi, China (enrolling)

Full record on ClinicalTrials.gov

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