drugset / Trial / NCT07604766

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 ↗

Phase 3 Recruiting 82 enrolled Genmab
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2026-06-26
Primary completion
2027-09
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gemcitabine Small molecule — Intravenous
Comparator Paclitaxel Small molecule — Intravenous
Comparator Pegylated liposomal doxorubicin (PLD) Unknown — Intravenous
Subject Rina-S Other / unclassified — Intravenous
Comparator Topotecan Small molecule — Intravenous