RecruitingPhase 3NCT07604766

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

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Platinum Resistant Ovarian Cancer


Sponsor

Genmab

Enrollment

82 participants

Start Date

Jun 26, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Gemcitabine, a drug called Paclitaxel, and others for people with platinum resistant ovarian cancer. The study is currently recruiting participants at 17 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRina-S

Intravenous (IV) infusion

DRUGPaclitaxel

IV infusion

DRUGTopotecan

IV infusion

DRUGPegylated liposomal doxorubicin (PLD)

IV infusion

DRUGGemcitabine

IV infusion


Locations(17)

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

West China Second University Hospital, Sichuan University

Chengdu, China

Chongqing University Cancer Hospital - Chongqing Cancer Hospital

Chongqing, China

Sun Yat-Sen Memorial Hospital

Guangzhou, China

Sun Yat-Sen University Cancer Center

Guangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Shandong First Medical University Affiliated Tumor Hospital

Jinan, China

Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)

Nanjing, China

Fudan University Shanghai Cancer Hospital

Shanghai, China

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Liaoning Cancer Hospital

Shenyang, China

Shanxi Cancer Hospital

Taiyuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China

View Full Details on ClinicalTrials.gov

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NCT07604766


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