An Extension Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer in China
NCT07604766 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 82
Last updated 2026-05-22
Summary
The purpose of this Chinese extension study is to compare how well Rina-S works against platinum-resistant ovarian cancer compared to chemotherapy drugs that are already approved and used for platinum-resistant ovarian cancer.
Treatment in this study could be Rina-S or it could be 1 of 4 indicated chemotherapy agents that are considered standard medical care. There is an equal (50:50) chance of getting Rina-S or an approved chemotherapy agent as treatment in this study. No one will know what treatment they are assigned to until the first dose.
All participants will receive active drug; no one will be given placebo.
This study is an extension study of the protocol GCT1184-02 (NCT06619236).
Conditions
Interventions
- DRUG
-
Rina-S
Intravenous (IV) infusion
- DRUG
-
IV infusion
- DRUG
-
Topotecan
IV infusion
- DRUG
-
Pegylated liposomal doxorubicin (PLD)
IV infusion
- DRUG
-
IV infusion
Sponsors & Collaborators
-
Genmab
lead INDUSTRY
Principal Investigators
-
Study Official · Genmab
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-09-30
- Completion
- 2028-12-31
Countries
- China
Study Locations
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