A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]

May 15, 2026 updated by: Nanjing Leads Biolabs Co.,Ltd

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 03(ESCC)]

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 oesophageal squamous cell carcinoma (ESCC),to evaluate the efficacy and safety of LBL-024 combination therapy.

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
    • Henan
      • Anyang, Henan, China, 455000
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
      • Zhengzhou, Henan, China, 450000
      • Zhengzhou, Henan, China, 451191
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Shandong
      • Jinan, Shandong, China, 250117
    • Sichuan
      • Suining, Sichuan, China, 629099

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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:

  1. 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 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, 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: LBL-024 for Injection
Intravenous infusion
Other Names:
  • LBL-024
Drug: Cisplatin Injection
Intravenous infusion
Other Names:
  • Cisplatin
Drug: Paclitaxel Injection
Intravenous infusion
Other Names:
  • Paclitaxel
Drug: 5-Fluorouracil injection
Intravenous infusion
Other Names:
  • 5-Fluorouracil
Drug: Capecitabine tablets
Oral administration
Other Names:
  • Capecitabine
Active Comparator: 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.
Drug: Cisplatin Injection
Intravenous infusion
Other Names:
  • Cisplatin
Drug: Paclitaxel Injection
Intravenous infusion
Other Names:
  • Paclitaxel
Drug: 5-Fluorouracil injection
Intravenous infusion
Other Names:
  • 5-Fluorouracil
Drug: Capecitabine tablets
Oral administration
Other Names:
  • Capecitabine
Drug: Tislelizumab Injection
Intravenous infusion
Other Names:
  • Tislelizumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate(DCR）
Time Frame: 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)
Percentage of participants achieving CR and PR and stable disease (SD).
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）
Time Frame: 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)
The period from the participants first achieving CR or PR to disease progression.
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
Time Frame: 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)
Maximum serum concentration
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
Time Frame: 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)
After taking a single dose, Time to reach maximum plasma concentration
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
Time Frame: 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)
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Collaborators

Peking University Cancer Hospital & Institute

Investigators

  • Principal Investigator: Lin Shen, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2026

Primary Completion (Estimated)

December 26, 2028

Study Completion (Estimated)

December 26, 2028

Study Registration Dates

First Submitted

December 28, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-024-CN004_03(ESCC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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