A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 02(BTC&HCC)]

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-20

Study Completion Date

2026-12-26

Brief Summary

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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.

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Detailed Description

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This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with Advanced biliary tract cancer (BTC) and hepatocellular carcinoma (HCC), to evaluate the efficacy and safety of LBL-024 combination therapy.The trial included two cohorts.

Cohort 1: This cohort will have a safety run-in period,a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the 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. Eligible subjects will be randomized to either the LBL-024 treatment arm or the control arm.

Cohort 2: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After completing the 21-day safety observation, the safety and tolerability of the combination drugs will be assessed. The sponsor and investigator assessed the safety and tolerability of the combination drugs as good,and then the cohort will continue to enroll subjects.

The trial will enroll up to 172 subjects.

Conditions

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Advanced Solid Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LBL-024+Gemcitabine Hydrochloride+Cisplatin/Durvalumab+Gemcitabine Hydrochloride+Cisplatin

Cohort 1：

Subjects were treated with LBL-024 combined with gemcitabine and cisplatin

or durvalumab combined with gemcitabine and cisplatin.

Intravenous infusion.

Group Type EXPERIMENTAL

LBL-024 for Injection

Intervention Type DRUG

Intravenous infusion.

Durvalumab Injection

Intervention Type DRUG

Intravenous infusion.

Cisplatin Injection

Intervention Type DRUG

Intravenous infusion.

Gemcitabine Hydrochloride for Injection

Intervention Type DRUG

Intravenous infusion.

LBL-024+Bevacizumab

Cohort 2：

Subjects were treated with LBL-024 combined with Bevacizumab.

Intravenous infusion.

Group Type EXPERIMENTAL

LBL-024 for Injection

Intervention Type DRUG

Intravenous infusion.

Bevacizumab Injection

Intervention Type DRUG

Intravenous infusion.

Interventions

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LBL-024 for Injection

Intravenous infusion.

Intervention Type DRUG

Durvalumab Injection

Intravenous infusion.

Intervention Type DRUG

Cisplatin Injection

Intravenous infusion.

Intervention Type DRUG

Gemcitabine Hydrochloride for Injection

Intravenous infusion.

Intervention Type DRUG

Bevacizumab Injection

Intravenous infusion.

Intervention Type DRUG

Other Intervention Names

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LBL-024 Durvalumab Cisplatin Gemcitabine Hydrochloride Bevacizumab

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. Age 18-75 years (inclusive of boundaries) at the time of signing informed consent form.
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 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.

Exclusion Criteria

1. 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.
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 infection and currently requiring intravenous anti-infective therapy.
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. Women during pregnancy or lactation.
7. History of mental illness (interfering with understanding or giving informed consent), drug abuse, alcoholism or drug addiction.
8. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian zhou

Role: PRINCIPAL_INVESTIGATOR

Shanghai Zhongshan Hospital

Locations

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