Loading clinical trials...

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

RECRUITINGPHASE2

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

NCT07331155•Nanjing Leads Biolabs Co.,Ltd

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (7)

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

Key Dates

Start Date

February 26, 2026

Primary Completion Date

December 26, 2028

Completion Date

December 26, 2028

Last Updated

March 9, 2026

Enrollment

110

ESTIMATED participants

Conditions

Advanced Solid Tumour

Interventions

LBL-024 for Injection

DRUG

Cisplatin Injection

DRUG

Paclitaxel Injection

DRUG

Tislelizumab Injection

DRUG

5-Fluorouracil injection

DRUG

Capecitabine tablets

DRUG

Contacts

Lin Shen

CONTACT

010-88121122 doctorshenlin@sina.cn

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

NCT06815575

Solid TumoursAdvanced Solid Tumours

View study

COMPLETEDPHASE1/PHASE2

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

NCT05508334

Advanced Solid Tumours

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

A Study to Assess the Safety and Tolerability of RC88 for Patients With Advanced Solid Tumours

Metronomic Oral Vinorelbine Plus Anti-PD-L1/Anti-CTLA4 ImmunothErapy in Patients With Advanced Solid Tumours

A Study to Assess the Safety and Tolerability of Adavosertib for Patients With Advanced Solid Tumours

Capivasertib China PK Study

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.