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

NCT07111546 | Recruiting Phase 2 DMC

• 1 other identifier: LBL-024-CN004_02(BTC & HCC)
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Advanced Solid Tumour

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

Secondary Outcomes (5)

• Disease Control Rate(DCR）

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

• Duration of Response(DOR）

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

• Cmax

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

• Tmax

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

• immunogenicity

  From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)

Study Arms (1)

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

EXPERIMENTAL

Cohort 1： Subjects were treated with LBL-024 combined with gemcitabine and cisplatin Cohort 2： Subjects were treated with LBL-024 combined with Bevacizumab. Intravenous infusion.

Drug: LBL-024 for Injection; Drug: Cisplatin Injection; Drug: Gemcitabine Hydrochloride for Injection; Drug: Bevacizumab Injection

Interventions

Gemcitabine Hydrochloride for Injection DRUG

Intravenous infusion.

Also known as: Gemcitabine Hydrochloride

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

LBL-024 for Injection DRUG

Intravenous infusion.

Also known as: LBL-024

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

Cisplatin Injection DRUG

Intravenous infusion.

Also known as: Cisplatin

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

Bevacizumab Injection DRUG

Intravenous infusion.

Also known as: Bevacizumab

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 18-75 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead
• Shanghai Zhongshan Hospital: collaborator

Study Sites (6)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, 441106, China

NOT YET RECRUITING

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

RECRUITING

Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Sir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Interventions

Injections; Cisplatin; Gemcitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jian zhou

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian zhou

CONTACT

021-64041990; maxy@leadsbiolabs.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 8, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): December 26, 2027
• Study Completion (Estimated): December 26, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)