RecruitingPhase 2NCT07390383
A Phase II Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumour[Substudy 04]
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 04]
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Enrollment
110 participants
Start Date
Apr 13, 2026
Study Type
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
Min Age: 18 Years
Inclusion Criteria8
- 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.
Exclusion Criteria8
- 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.
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Interventions
DRUGLBL-024 for Injection
Intravenous infusion
DRUGCapecitabine tablets
Oral administration
DRUGTislelizumab Injection
Intravenous infusion
DRUGOxaliplatin injection
Intravenous infusion
Locations(6)
View Full Details on ClinicalTrials.gov
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NCT07390383
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