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 | Recruiting Phase 3 DMC

• 2 other identifiers: GCT1184-02 Extension StudyCTR20253987
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 17

Brief 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

Platinum-resistant Ovarian Cancer

Keywords

antibody-drug conjugate; folate receptor alpha (FRα); ovarian cancer; fallopian tube cancer; primary peritoneal cancer; folate receptor; platinum-resistant ovarian cancer (PROC); rinatabart sesutecan; Topoisomerase 1 inhibitor; PRO1184; GEN1184

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  PFS is defined as the time from the date of randomization to the date of the first documented progression or death (PD) due to any cause, whichever occurs first based on response evaluation criteria in solid tumors (RECIST) version 1.1 as assessed by the investigator.

  Up to approximately 16 months

Secondary Outcomes (10)

• Overall Survival (OS)

  Up to approximately 25 months

• Objective Response Rate (ORR)

  Up to approximately 25 months

• PFS as Determined by BICR

  Up to approximately 16 months

• ORR as Determined by BICR

  Up to approximately 25 months

• Duration of Response (DOR)

  Up to approximately 25 months

Study Arms (2)

Rina-S

EXPERIMENTAL

Drug: Rina-S

Investigator's Choice

ACTIVE COMPARATOR

Drug: Paclitaxel; Drug: Topotecan; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Gemcitabine

Interventions

Rina-S DRUG

Intravenous (IV) infusion

Also known as: PRO1184, Rinatabart Sesutecan, GEN1184

Rina-S

Paclitaxel DRUG

IV infusion

Investigator's Choice

Topotecan DRUG

IV infusion

Investigator's Choice

Pegylated liposomal doxorubicin (PLD) DRUG

IV infusion

Investigator's Choice

Gemcitabine DRUG

IV infusion

Investigator's Choice

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically or cytologically confirmed high grade serous or endometrioid epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer.
• Participants may be enrolled regardless of FRα expression level.
• Participants must have received 1 to 4 prior lines of therapy. Participants must have progressed radiographically on or after their most recent line of therapy.
• Participants must have received prior treatment with the following therapies:
• Platinum chemotherapy
• Prior bevacizumab (or biosimilar) treatment is required, if labeled and available as standard of care per institutional guidelines, unless the participant has a documented contraindication or unless the participant is not eligible for treatment with bevacizumab (or biosimilar) due to precautions/intolerance
• Participants with known or suspected deleterious germline or somatic breast cancer gene (BRCA) mutations and who achieved a complete or partial response to platinum-based chemotherapy must have been treated with a poly ADP-ribose polymerase (PARP) inhibitor as maintenance treatment unless the participant is not eligible for treatment with PARP inhibitor
• Mirvetuximab soravtansine, if:
• Mirvetuximab soravtansine is available in the enrollment region, and
• The participant is eligible, and
• The participant does not have a documented medical exception, including chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring, such as uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal injections, active diabetic retinopathy with macular edema, macular degeneration, presence of papilledema, and /or monocular vision.
• Participants must have platinum-resistant disease:
• Participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of platinum therapy, and must have either had a response (CR or PR) or had non-measurable disease at the start of adjuvant platinum-based therapy, and then progressed between \> 91 days and ≤ 183 days after the date of the last dose of platinum.
• Participants who have received a protocol defined number of lines of platinum-based therapy must have progressed on or within 183 days after the date of the last dose of platinum.

You may not qualify if:

• Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
• Have primary platinum-refractory disease, defined as ovarian cancer that did not respond (CR or PR) to or progressed ≤ 91 days after the last dose of a first-line platinum-containing regimen.
• History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, ductal carcinoma in situ, or Stage I uterine cancer.
• Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
• Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past 91 days or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility.
• Participant has clinically significant ascites/pleural effusion. Enrollment of participants with an indwelling catheter flush/drain is not allowed. Note: Clinically significant is defined as (1) symptomatic, or (2) requires therapeutic paracentesis/thoracentesis within 8 weeks of the first dose, or (3) recurrent ascites/pleural effusion that necessitates multiple paracentesis/thoracocentesis procedures more often than approximately every 4 weeks.

Sponsors & Collaborators

• Genmab: lead

Study Sites (17)

The First Hospital of Jilin University

Changchun, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

RECRUITING

West China Second University Hospital, Sichuan University

Chengdu, China

RECRUITING

Chongqing University Cancer Hospital - Chongqing Cancer Hospital

Chongqing, China

RECRUITING

Sun Yat-Sen Memorial Hospital

Guangzhou, China

RECRUITING

Sun Yat-Sen University Cancer Center

Guangzhou, China

RECRUITING

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, China

RECRUITING

Shandong First Medical University Affiliated Tumor Hospital

Jinan, China

RECRUITING

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

Nanjing, China

RECRUITING

Fudan University Shanghai Cancer Hospital

Shanghai, China

RECRUITING

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, China

RECRUITING

Liaoning Cancer Hospital

Shenyang, China

RECRUITING

Shanxi Cancer Hospital

Taiyuan, China

RECRUITING

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Interventions

Paclitaxel; Topotecan; liposomal doxorubicin; Gemcitabine

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start: June 26, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (17)