NCT07042802

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P75+ for phase_1 ovarian-cancer

Timeline
32mo left

Started Dec 2025

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

June 17, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 29, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2028

Last Updated

March 6, 2026

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

June 17, 2025

Last Update Submit

March 5, 2026

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

  • Objective Response Rate (ORR)

    According to the evaluation criteria of RECIST V1.1 (solid tumour) ,Proportion of subjects achieving complete response (CR) or partial response (PR).It was used to evaluate the efficacy in Phase Ib.

    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)

  • Occurrence of adverse event (AE) and serious adverse event (SAE)

    Adverse event (AE) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0.The safety profile of LBL-024 in combination with paclitaxel will be assessed by monitoring the adverse event (AE) and serious adverse event (SAE) in Phase Ib study.

    From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (90 days after drug withdrawal or before the start of new anti-tumor therapy)

  • Progression-free Survival(PFS)

    According to the evaluation criteria of RECIST V1.1 (solid tumour),Time from randomisation to disease progression or death from any cause.It was used to evaluate Time of disease no-progression or Drug resistance in Phase II.

    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)

  • 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)

  • 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)

Study Arms (2)

LBL-024+paclitaxel

EXPERIMENTAL

Experimental group：LBL-024+Paclitaxel. LBL-024 and Paclitaxel Intravenous infusion.

Drug: LBL-024 for InjectionDrug: Paclitaxel Injection

Paclitaxel

ACTIVE COMPARATOR

control group： Paclitaxel. Paclitaxel Intravenous infusion.

Drug: Paclitaxel Injection

Interventions

LBL-024 for InjectionDRUG

LBL-024 Intravenous infusion.

Also known as: LBL-024
LBL-024+paclitaxel
Paclitaxel InjectionDRUG

Paclitaxel Intravenous infusion.

Also known as: Paclitaxel
LBL-024+paclitaxelPaclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • At the time of signing the informed consent form, the age was ≥ 18 years old, and the gender was not limited.
  • 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 （Response Evaluation Criteria in Solid Tumours），the subjects enrolled have at least one measurable lesion.
  • 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.

You may not qualify if:

  • 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.
  • Use of immunomodulatory drugs within 2 weeks prior to the first use of study drug.
  • 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.
  • Patients with clinically uncontrollable pleural effusion, pericardial effusion or ascites, and those requiring repeated drainage or medical intervention.
  • The patient has a Medical history of immunodeficiency, including HIV antibody positive.
  • Active hepatitis B or active hepatitis C.
  • Women during pregnancy or lactation.
  • History of mental and/or psychiatric illness (impairing 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

Beijing Obstetrics and Gynecology Hospital Capital Medical University

Beijing, Beijing Municipality, 100026, China

NOT YET RECRUITING

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

NOT YET RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

AnYang Tumor Hospital

Anyang, Henan, 455000, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221006, China

NOT YET RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

NOT YET RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Tianjin Medical University Cancer Institute &Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Yunnan Cancer Hospital

Kunming, Yunnan, 650106, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

InjectionsPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • lingying wu

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

lingying wu

CONTACT

025-83378099mengdongtao@leadsbiolabs.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 29, 2025

Study Start

December 2, 2025

Primary Completion (Estimated)

December 25, 2027

Study Completion (Estimated)

December 25, 2028

Last Updated

March 6, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(13)