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NOT YET RECRUITING
NCT07545460
PHASE3

A Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

Official title: A Phase III Randomized Controlled Clinical Study Comparing BL-M07D1 With Physician's Choice of Chemotherapy in Patients With HER2-Expressing Platinum-Resistant Recurrent Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

404

Start Date

2026-07

Completion Date

2028-12

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

BL-M07D1

Administration by intravenous infusion for a cycle of 3 weeks.

DRUG

Liposomal Doxorubicin

Administration by intravenous infusion for a cycle of 4 weeks.

DRUG

Paclitaxel

Administration by intravenous infusion for a cycle of 4 weeks.

DRUG

Topotecan

Administration by intravenous infusion for a cycle of 4 weeks.

Locations (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China