A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]
NCT ID: NCT07331155
Last Updated: 2026-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2026-01-30
2028-12-26
Brief Summary
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Detailed Description
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This study will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 combination therapy.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled, and the randomized, open, positive control trial design will be adopted.Subjects who meet the criteria will be randomly assigned to the experimental group and the control group in a ratio of 2: 1.
This trial will enroll up to 110 subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatin
LBL-024+Paclitaxel+Cisplatin/LBL-024+5-Fluorouracil/capecitabine + cisplatin.
Capecitabine is orally administered and other drugs are Intravenous infusion.
LBL-024 for Injection
Intravenous infusion
Cisplatin Injection
Intravenous infusion
Paclitaxel Injection
Intravenous infusion
5-Fluorouracil injection
Intravenous infusion
Capecitabine tablets
Oral administration
Tislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatin
Tislelizumab+Paclitaxel+Cisplatin/Tislelizumab+5-Fluorouracil/capecitabine + cisplatin.
Capecitabine is orally administered and other drugs are Intravenous infusion.
Cisplatin Injection
Intravenous infusion
Paclitaxel Injection
Intravenous infusion
Tislelizumab Injection
Intravenous infusion
5-Fluorouracil injection
Intravenous infusion
Capecitabine tablets
Oral administration
Interventions
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LBL-024 for Injection
Intravenous infusion
Cisplatin Injection
Intravenous infusion
Paclitaxel Injection
Intravenous infusion
Tislelizumab Injection
Intravenous infusion
5-Fluorouracil injection
Intravenous infusion
Capecitabine tablets
Oral administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years at the time of signing the informed consent.
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
4. The expected survival time is at least 12 weeks.
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable lesion.
6. There is adequate organ and bone marrow function,Conforms to laboratory test results.
7. 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
2. Use of immunomodulatory drugs within 2 weeks before the first use of study drug,Including but not limited to thymopeptide, interleukins, interferon, etc.
3. Patients with active, or who have had and have the possibility of recurrence of autoimmune diseases.
4. Patients with clinically uncontrollable pleural effusion, pericardial effusion, ascites, and those requiring repeated drainage or medical intervention.
5. The patient has a Medical history of immunodeficiency, including HIV antibody positive.
6. Active hepatitis B or active hepatitis C.
7. Women during pregnancy or lactation.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
18 Years
ALL
No
Sponsors
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Peking University Cancer Hospital & Institute
OTHER
Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Lin Shen
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Beijing Cancer Hospital
Beijing, Beijing Municipality, China
AnYang Tumor Hospital
Anyang, Henan, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Shandong Cancer Hospital
Jinan, Shandong, China
Suining Central Hospital
Suining, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-024-CN004_03(ESCC)
Identifier Type: -
Identifier Source: org_study_id
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