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NOT YET RECRUITING
NCT07708753
PHASE3

A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers

Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

View on ClinicalTrials.gov

Summary

This is a randomized, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of SYS6043 versus investigator's choice chemotherapy in participants with platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube cancer.

Official title: A Randomized, Multicenter, Open-label, Phase 3 Clinical Trial Evaluating SYS6043 Versus Investigator's Choice Chemotherapy in Participants With Platinum-resistant Advanced Ovarian Cancer, Primary Peritoneal Cancer, and Fallopian Tube Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

460

Start Date

2026-07-01

Completion Date

2030-12-01

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

SYS6043

Participants in the experimental group will receive SYS6043, administered on Day 1 of each cycle.

DRUG

Liposomal doxorubicin, paclitaxel, or topotecan

Participants in the control group will receive investigator's choice chemotherapy: Liposomal doxorubicin 40 mg/m² every 28 days (Q4W), administered on Day 1 of each cycle; Paclitaxel 80 mg/m² every 28 days (Q4W), administered on Days 1, 8, 15, and 22 of each cycle; Topotecan 4 mg/m² every 28 days (Q4W), administered on Days 1, 8, and 15 of each cycle.