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 (RAINFOL-02)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Platinum-resistant Ovarian Cancer
• Intervention / Treatment: Drug: Paclitaxel; Drug: Gemcitabine; Drug: Pegylated liposomal doxorubicin (PLD); Drug: Topotecan; Drug: Rina-S

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Genmab Trial Information; Phone Number: +4570202728; Email: clinicaltrials@genmab.com

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital
  • Beijing, China
    • Peking Union Medical College Hospital
  • Chongqing, China
    • Chongqing University Cancer Hospital - Chongqing Cancer Hospital
  • Fujian, China
    • Fujian Provincial Cancer Hospital
  • Guangdong, China
    • Sun Yat-sen University Cancer Center
  • Guangdong, China
    • Sun Yat-Sen Memorial Hospital
  • Heilongjiang, China
    • Harbin Medical University Cancer Hospital
  • Henan, China
    • Henan Cancer Hospital
  • Hunan, China
    • Hunan Cancer Hospital
  • Jiangsu, China
    • Nanjing Drum Tower Hospital (The Affiliated Hospital of Nanjing University Medical School)
  • Jilin, China
    • The First Hospital of Jilin University
  • Liaoning, China
    • Liaoning Cancer Hospital
  • Shandong, China
    • Shandong Cancer Hospital
  • Shanghai, China
    • Fudan University Shanghai Cancer Hospital
  • Shanghai, China
    • Obstetrics & Gynecology Hospital of Fudan University
  • Shanxi, China
    • Shanxi Cancer Hospital
  • Shanxi, China
    • The First Affiliated Hospital of Xi'an Jiaotong University
  • Sichuan, China
    • West China Second University Hospital, Sichuan University
  • Tianjin, China
    • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang, China
    • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigator's Choice	Drug: Paclitaxel; IV infusion; Drug: Gemcitabine; IV infusion; Drug: Pegylated liposomal doxorubicin (PLD); IV infusion; Drug: Topotecan; IV infusion
Experimental: Rina-S	Drug: Rina-S; Intravenous (IV) infusion; Other Names: PRO1184; Rinatabart Sesutecan; GEN1184

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from date of randomization to date of death due to any cause.	Up to approximately 25 months
Objective Response Rate (ORR)	ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by the investigator.	Up to approximately 25 months
PFS as Determined by BICR	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 RECIST version 1.1 as determined by BICR.	Up to approximately 16 months
ORR as Determined by BICR	ORR is defined as the percentage of participants with BOR of CR or PR based on RECIST v1.1 as determined by BICR.	Up to approximately 25 months
Duration of Response (DOR)	DOR is defined as the time from the onset date of response to the date of the first documented progression or death due to any cause based on RECIST v1.1 as assessed by the investigator and by blinded independent central review (BICR).	Up to approximately 25 months
Percentage of Participants Who Achieved Cancer Antigen-125 (CA-125) Response per Gynecologic Cancer Intergroup (GCIG) Criteria	A CA-125 response per the GCIG criteria is defined as a ≥ 50% reduction in CA-125 levels from baseline.	Up to approximately 25 months
Time to Second Disease Progression or Death From any Cause (PFS2)	PFS2 is defined as the time from randomization to the date of the second PD (i.e., the first PD reported in subsequent anti-cancer therapies, or long-term follow up) or death.	Up to approximately 25 months
Overall Change From Baseline in Global Health Status/Quality of Life (GHS/Qol)	Overall change from baseline in GHS/Qol score (items 29 and 30) will be calculated using the European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC-QLQ-C30) questionnaire. The score ranges from 0 to 100. A high scale score represents a higher response level.	Baseline, up to approximately 25 months
Time to Deterioration (TTD) in the GHS/Qol Score	TTD in the GHS/Qol score is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) in GHS/QoL score. A longer TTD indicates a better outcome.	Up to approximately 25 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)		Up to approximately 25 months

Collaborators and Investigators

• Sponsor: Genmab
• Investigators: Study Director: Study Official, Genmab

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: ovarian cancer; fallopian tube cancer; primary peritoneal cancer; folate receptor; antibody-drug conjugate; platinum-resistant ovarian cancer (PROC); folate receptor alpha (FRα); rinatabart sesutecan; Topoisomerase 1 inhibitor; PRO1184; GEN1184
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Fallopian Tube Diseases; Ovarian Neoplasms; Fallopian Tube Neoplasms; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Diterpenes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine; Paclitaxel; Topotecan; liposomal doxorubicin
• Other Study ID Numbers: GCT1184-02 Extension Study; CTR20253987 (Registry Identifier: ChinaDrugTrials.org.cn)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No