A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]
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[Substudy Number 02(BTC&HCC)]
Nanjing Leads Biolabs Co.,Ltd
140 participants
Oct 20, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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 standard, the subjects enrolled have at least one measurable lesion.
- 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.
Exclusion Criteria8
- Participation in clinical studies of antineoplastic agents within 4 weeks before the first use of study drug,or Subject is expected to receive any other form of systemic or local 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 infection and requiring intravenous anti-infective therapy within 2 weeks before the first dose.
- 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.
- Women during pregnancy or lactation.
- History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
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Interventions
Intravenous infusion.
Intravenous infusion.
Intravenous infusion.
Intravenous infusion.
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07111546