A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]

Recruiting now · Phase 2

Conditions studied: Advanced Solid Tumour

In brief

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour.

Key facts

Study ID

NCT07390383

Run by

Nanjing Leads Biolabs Co.,Ltd

People needed

110

Starts

2026-04-13

Expected to finish

2028-05-30

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 years at the time of signing the informed consent.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• The expected survival time is at least 12 weeks.
• According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
• Patients with histologically confirmed unresectable locally advanced or metastatic gastric/gastroesophageal junction (G/GEJ) adenocarcinoma.
• There is adequate organ and bone marrow function,Conforms to laboratory test results.
• 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…

• Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or is expected to receive any other form of systemic anti-tumor therapy outside the protocol during the study.
• Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
• Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
• Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
• The patient has a Medical history of immunodeficiency, including HIV antibody positive.
• Active hepatitis B or active hepatitis C.
• Women during pregnancy or lactation.
• The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Where it is running

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China
• Shandong Cancer Hospital — Jinan, Shandong, China

Full record on ClinicalTrials.gov

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