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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
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
Conditions
Interventions
Rina-S
Intravenous (IV) infusion
Paclitaxel
IV infusion
Topotecan
IV infusion
Pegylated liposomal doxorubicin (PLD)
IV infusion
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