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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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\

• 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.

Locations
Other Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Zhejiang Cancer Hospital
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Tianjin Medical University Cancer Institute &Hospital
NOT_YET_RECRUITING
Tianjin
Contact Information
Primary
lingying wu
mengdongtao@leadsbiolabs.com
025-83378099
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2028-12-25
Participants
Target number of participants: 110
Treatments
Experimental: LBL-024+paclitaxel
Experimental group:LBL-024+Paclitaxel.~LBL-024 and Paclitaxel Intravenous infusion.
Active_comparator: Paclitaxel
control group: Paclitaxel.~Paclitaxel Intravenous infusion.
Related Therapeutic Areas
Sponsors
Leads: Nanjing Leads Biolabs Co.,Ltd

This content was sourced from clinicaltrials.gov

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