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NOT YET RECRUITING
NCT07604766
PHASE3

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

Sponsor: Genmab

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2026-06

Completion Date

2028-12

Last Updated

2026-06-02

Healthy Volunteers

No

Interventions

DRUG

Rina-S

Intravenous (IV) infusion

DRUG

Paclitaxel

IV infusion

DRUG

Topotecan

IV infusion

DRUG

Pegylated liposomal doxorubicin (PLD)

IV infusion

DRUG

Gemcitabine

IV infusion

Locations (20)

Beijing Cancer Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

Chongqing University Cancer Hospital - Chongqing Cancer Hospital

Chongqing, China

Fujian Provincial Cancer Hospital

Fujian, China

Sun Yat-Sen Memorial Hospital

Guangdong, China

Sun Yat-Sen University Cancer Center

Guangdong, China

Harbin Medical University Cancer Hospital

Heilongjiang, China

Henan Cancer Hospital

Henan, China

Hunan Cancer Hospital

Hunan, China

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

Jiangsu, China

The First Hospital of Jilin University

Jilin, China

Liaoning Cancer Hospital

Liaoning, China

Shandong Cancer Hospital

Shandong, China

Fudan University Shanghai Cancer Hospital

Shanghai, China

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

Shanxi Cancer Hospital

Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Shanxi, China

West China Second University Hospital, Sichuan University

Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Zhejiang Cancer Hospital

Zhejiang, China