A Phase Ib/Ⅱ Clinical Trial of LBL-024 Combined With Paclitaxel in Patients With Platinum-resistant Ovarian Cancer
NCT ID: NCT07042802
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2025-12-02
2028-12-25
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LBL-024+paclitaxel
Experimental group：LBL-024+Paclitaxel.
LBL-024 and Paclitaxel Intravenous infusion.
LBL-024 for Injection
LBL-024 Intravenous infusion.
Paclitaxel Injection
Paclitaxel Intravenous infusion.
Paclitaxel
control group： Paclitaxel.
Paclitaxel Intravenous infusion.
Paclitaxel Injection
Paclitaxel Intravenous infusion.
Interventions
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LBL-024 for Injection
LBL-024 Intravenous infusion.
Paclitaxel Injection
Paclitaxel Intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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lingying wu
Role: PRINCIPAL_INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital
Jinan, Shandong, China
Tianjin Medical University Cancer Institute &Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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dongtao meng
Role: primary
dongtao meng
Role: primary
dongtao meng
Role: primary
dongtao meng
Role: primary
dongtao meng
Role: primary
dongtao meng
Role: primary
Other Identifiers
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LBL-024-CN006
Identifier Type: -
Identifier Source: org_study_id