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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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

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.

• 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 Participants 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
AnYang Tumor Hospital
RECRUITING
Anyang
Beijing Obstetrics and Gynecology Hospital Capital Medical University
NOT_YET_RECRUITING
Beijing
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Fujian Cancer Hospital
NOT_YET_RECRUITING
Fuzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Zhejiang Cancer Hospital
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
Shandong Cancer Hospital
RECRUITING
Jinan
Yunnan Cancer Hospital
RECRUITING
Kunming
The First Hospital of China Medical University
RECRUITING
Shenyang
Tianjin Medical University Cancer Institute &Hospital
RECRUITING
Tianjin
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
lingying wu
mengdongtao@leadsbiolabs.com
025-83378099
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2028-12-25
Participants
Target number of participants: 180
Treatments
Experimental: LBL-024 + Paclitaxel injection
LBL-024 + Paclitaxel injection.~Intravenous infusion.
Experimental: LBL-024 + Paclitaxel injection + bevacizumab
LBL-024 + Paclitaxel injection + bevacizumab.~Intravenous infusion.
Experimental: LBL-024 in Combination With paclitaxel ± bevacizumab
LBL-024 in Combination With paclitaxel ± bevacizumab.~Intravenous infusion.
Active_comparator: Paclitaxel ± bevacizumab
Paclitaxel ± bevacizumab.~Intravenous infusion.
Related Therapeutic Areas
Sponsors
Leads: Nanjing Leads Biolabs Co.,Ltd

This content was sourced from clinicaltrials.gov

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