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A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

An Open-label, Multicenter Phase Ib/Ⅱ Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Paclitaxel Injection in Patients With Platinum-resistant Ovarian Cancer

NCT07042802•Nanjing Leads Biolabs Co.,Ltd

View on ClinicalTrials.gov

Summary

This trial is an open-label, multicenter phase Ib/II clinical study of LBL-024 combination therapy in patients with platinum-resistant ovarian cancer (OC),To evaluate the efficacy and safety of LBL-024 combination therapy in the treatment of advanced recurrent platinum-resistant ovarian cancer (OC) patients.

Detailed Description

The trial was divided into two phases. Stage I (Phase Ib): Single-Arm Safety Lead-In Period. In this stage, a small number of subjects were enrolled first and received LBL-024 combined with paclitaxel treatment, with 21 days as a cycle.Safety, tolerability and preliminary efficacy of combination drugs were assessed by the sponsor and investigators.LBL-024 Dose De-escalation Principle Based on Safety and Tolerability. Stage II (Phase II) Randomized, Expansion Cohort Study. If safety and tolerability are good, the combined administration extension study will be continued. Subjects were continued to be enrolled in the study. The study was designed as a randomized, open-label, positive-controlled trial.Subjects who met the criteria were randomly assigned to the experimental group and the control group in a ratio of 2: 1.Experimental group (LBL-024 combined with paclitaxel) and Control group (paclitaxel monotherapy). This study 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. At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
•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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
•6. Females of childbearing age are willing to take highly effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug;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. The subject is currently participating in any other clinical trial,Or has received or is receiving other investigational agents within 4 weeks prior to the first dose of study drug.
•2. Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
•3. Patients with active infection and currently requiring systemic treatment. active pulmonary tuberculosis (TB), receiving anti-tuberculosis treatment or Received anti-tuberculosis treatment within 6 months before screening.
•4. Patients with clinically uncontrollable pleural effusion, pericardial effusion or 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. History of mental and/or psychiatric illness (impairing understanding or giving informed consent), drug abuse, alcoholism, or drug addiction.
•9. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Locations (13)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Beijing Obstetrics and Gynecology Hospital Capital Medical University

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

AnYang Tumor Hospital

Anyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Key Dates

Start Date

December 2, 2025

Primary Completion Date

December 25, 2027

Completion Date

December 25, 2028

Last Updated

March 6, 2026

Enrollment

110

ESTIMATED participants

Conditions

Ovarian Cancer

Interventions

LBL-024 for Injection

DRUG

Paclitaxel Injection

DRUG

Contacts

lingying wu

CONTACT

025-83378099 mengdongtao@leadsbiolabs.com

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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 6, 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 Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer

Inclusion Criteria

Exclusion Criteria

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