Study to Assess the Efficacy of Rina-S Compared to Treatment of Investigator's Choice in Participants With Platinum Resistant Ovarian Cancer (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

This phase 3 study will be conducted in different countries all over the world.

The purpose of this 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.

Study Overview

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

Detailed Description

The China extension-study of GCT1184-02 is registered under NCT07604766.

• Study Type: Interventional
• Enrollment (Estimated): 530
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • South Brisbane, Australia
    • Mater Misericordiae - Mater Hospital Brisbane
  • Subiaco, Australia, 6008
    • Saint John of God - Subiaco Hospital
  • New South Wales
    • New Lambton Heights, New South Wales, Australia
      • Newcastle Private Hospital
  • Queensland (qld)
    • South Brisbane, Queensland (qld), Australia, 4101
      • ICON Cancer Centre
• Austria
  • Graz, Austria, 8036
    • Medizinische Universitat Graz
  • Vienna, Austria, 1090
    • Medizinische Universitat Wien
  • State of Vienna
    • Vienna, State of Vienna, Austria, 1130
      • Krankenhaus Hietzing
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Medizinische Universitat Innsbruck
  • Upper Austria (Oberösterreich)
    • Linz, Upper Austria (Oberösterreich), Austria, 4010
      • Ordensklinikum Linz GmbH Barmherzige Schwestern
• Belgium
  • Aalst, Belgium, 9300
    • AZORG - Onze-Lieve-Vrouwziekenhuis - Campus Aalst
  • Brussels, Belgium, 1000
    • Centre Hospitalier Universitaire Saint-Pierre
  • Charleroi, Belgium, 6000
    • Grand Hopital de Charleroi - Site Les Viviers
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis (UZ) Leuven - Campus Gasthuisberg
  • Liège, Belgium, 4000
    • Centre Hospitalier Chretien - Clinique MontLégia
  • Roeselare, Belgium, 051237111
    • Algemeen Ziekenhuis Delta - Campus Rumbeke
  • Antwerp
    • Turnhout, Antwerp, Belgium, 2300
      • Algemeen Ziekenhuis Turnhout - Campus Sint-Elisabeth
• Canada
  • Toronto, Canada, M4Y 3M5
    • Sunnybrook Health Sciences Centre - Bayview Campus
  • Ontario
    • Toronto, Ontario, Canada, M5G2M9
      • Princess Margaret Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X0C1
      • Centre Hospitalier de l'Université de Montréal (CHUM)
• China
  • Changchun, China, 130021
    • the First Hospital of Jilin University
  • Hanzhou, China
    • Zhejiang Cancer Hospital
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute & Hospital
  • Zhengzhou, China
    • Henan Cancer Hospital - Zhengzhou University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Shaanxi
    • Xi'an, Shaanxi, China, 710049
      • The First Affiliated Hospital of Xi'an Jiaotong University
• Czechia
  • Brno, Czechia, 60200
    • Masaryk Memorial Cancer Institute
  • Hradec Králové, Czechia, 50005
    • Fakultni nemocnice Hradec Kralove
  • Nový Jičín, Czechia, 74101
    • Nemocnice AGEL Nový Jičín a.s.
  • Prague, Czechia, 12808
    • Vseobecna fakultni nemocnice v Praze
  • Prague, Czechia, 15000
    • Fakultni nemocnice v Motole
  • Prague, Czechia, 18000
    • Bulovka University Hospital
  • Prague
    • Prague, Prague, Czechia
      • University Hospital Kralovske Vinohrady
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Copenhagen, Denmark
    • The Royal Hospital (Rigshospitalet)
  • Odense, Denmark, 5000
    • Odense Universitets Hospital
• France
  • Nice, France, 6189
    • Centre Antoine Lacassagne
  • Paris, France, 75015
    • Hopital Europeen Georges-Pompidou
  • Pierre-Bénite, France, 69310
    • Hospital Lyon-Sud (HCL)
  • Rennes, France, 35042
    • Centre Eugene Marquis
  • Saint-Herblain, France, 44800
    • Western Cancer Institute - Saint-Herblain - René Gauducheau Site
  • Toulouse, France, 31059
    • Institut Universitaire du Cancer de Toulouse (IUCT) Oncopole
  • Villejuif, France, 94805
    • Gustave Roussy
• Germany
  • Berlin, Germany, 13125
    • HELIOS Klinikum Berlin-Buch
  • Bonn, Germany, 53127
    • University Hospital Bonn
  • Dresden, Germany, 01307
    • University Hospital Carl Gustav Carus Dresden
  • Düsseldorf, Germany, 40225
    • university hospital of Düsseldorf
  • Essen, Germany, 45136
    • Kliniken Essen-Mitte - Evangelische Huyssens-Stiftung
  • Frankfurt, Germany, 60596
    • Klinikum der Johann Wolfgang Goethe-Universität
  • Giessen, Germany, 35392
    • Universitätsklinikum Gießen und Marburg - Gießen (UKGM)
  • Hamburg, Germany, 20357
    • Mammazentrum Hamburg am Krankenhaus Jerusalem
  • Hanover, Germany, 30449
    • MVZ Onko Medical GmbH Hanover
  • Heidelberg, Germany, 69120
    • University Hospital Heidelberg /Universitätsklinikum Heidelberg
  • Homburg, Germany, 66421
    • University Hospital of Saarland
  • Munich, Germany, 80634
    • Red Cross Hospital Munich
  • Münster, Germany, 48149
    • Universitätsklinikum Münster/University Clinic Muenster
  • Wiesbaden, Germany, 65199
    • Helios Dr. Horst Schmidt Kliniken Wiesbaden
• Greece
  • Athens, Greece, 11527
    • General Hospital of Athens
  • Chaïdári, Greece, 12462
    • Attikon University General Hospital/General Hospital of West Attica
  • Léfkos, Greece, 2024
    • Aretaieio Hospital
  • Panórama, Greece
    • Saint Luke's Hospital
• Italy
  • Milan, Italy, 20132
    • Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele
  • Milan, Italy, 20141
    • Istituto Europeo di Oncologia/ European Institute of Oncology
  • Milan, Italy, 20159
    • Humanitas San Pio X
  • Ponderano, Italy, 13875
    • Local Health Authority of Biella - Nuovo Ospedale degli Infermi
  • Roma, Italy, 00168
    • Agostino Gemelli University Hospital Foundation IRCCS
  • Torino, Italy, 10128
    • Centre Antoine Lacassagne/Azienda Ospedaliera Ordine Mau
  • Apulia
    • Brindisi, Apulia, Italy, 72100
      • Azienda Sanitaria Locale Brindisi
• Japan
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 135-8550
    • Cancer Institute Hospital of JFCR
  • Aichi Pref
    • Nagoya, Aichi Pref, Japan, 4648681
      • Aichi Cancer Center
  • Fukuoka Pref
    • Kurume, Fukuoka Pref, Japan, 8300011
      • Kurume University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 0300804
      • Hokkaido Cancer Center
  • Kanagawa Pref
    • Kawasaki, Kanagawa Pref, Japan, 2160015
      • St. Marianna University Hospital
  • Miyagi Pref
    • Sendai, Miyagi Pref, Japan, 9808574
      • Tohoku University Hospital
  • Niigata Pref
    • Niigata, Niigata Pref, Japan, 9518520
      • Niigata University Medical And Dental Hospital
  • Okayama Pref.
    • Okayama, Okayama Pref., Japan, 7008558
      • Okayama University Hospital
  • Saitama Pref.
    • Hidaka, Saitama Pref., Japan, 350-1298
      • Saitama Medical University - International Medical Center
  • Shizuoka Pref.
    • Nagaizumi-chō, Shizuoka Pref., Japan, 4118777
      • Shizuoka Cancer Center
  • Tochigi Pref.
    • Saitama, Tochigi Pref., Japan, 329-0498
      • Jichi Medical University Hospital
  • Tokyo
    • Minato, Tokyo, Japan, 105-0003
      • The Jikei University Hospital
  • Toon City, Ehime Pref
    • Shibukawa, Toon City, Ehime Pref, Japan, 791-0295
      • Ehime University Hospital
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • Amsterdam UMC, location VUmc
  • Enschede, Netherlands, 7512 AV
    • Medisch Spectrum Twente - Enschede Koningsplein
  • Leiden, Netherlands, 2333
    • Leids Universitair Medisch Centrum (LUMC)
  • Maastricht, Netherlands, 6229
    • Maastricht (UMC) Universitair Medisch Centrum
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC/ Erasmus Medisch Centrum
• Norway
  • Oslo, Norway, 0379
    • Oslo Universitetssykehus - Radiumhospitalet
  • Tromsø, Norway, 9019
    • University Hospital of North Norway/Universitetssykehuset Nord-Norge - Tromsø
• Poland
  • Bialystok, Poland, 15-027
    • Białostockie Centrum Onkologii im. Marii Skłodowskiej- Curie w Białymstoku
  • Gdansk, Poland, 80-211
    • Uniwersyteckie Centrum Kliniczne w Gdansku
  • Lodz, Poland, 93-338
    • Instytut Centrum Zdrowia Matki Polki
  • Poznan, Poland, 61-867
    • Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie
  • Siedlce, Poland, 08-110
    • Mazowiecki Szpital Wojewódzki im. św. Jana Pawła II w Siedlcach
  • Szczecin, Poland, 70-111
    • Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
  • Lesser Poland (Małopolskie)
    • Krakow, Lesser Poland (Małopolskie), Poland, 30-348
      • Jagiellońskie Centrum Innowacj
• Puerto Rico
  • San Juan
    • Monacillo, San Juan, Puerto Rico, 00927
      • UPR Comprehensive Cancer Center Hospital
• Spain
  • A Coruña, Spain, 15006
    • Hospital Universitario de A Coruña
  • Donostia / San Sebastian, Spain, 20014
    • Hospital Universitario de Donostia
  • El Palmar, Spain, 30120
    • Hospital Clinico Universitario Virgen de La Arrixaca
  • Madrid, Spain, 28033
    • MD Anderson Cancer Center Madrid
  • Madrid, Spain, 28029
    • Hospital Universitario La Paz
  • Seville, Spain, 41013
    • Virgen del Rocio University Hospital
  • Valencia, Spain, 46009
    • IVO - Valencian Institute of Oncology Foundation
  • Zaragoza, Spain, 50009
    • Miguel Servet Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Women's Cancer Care
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Arizona Center for Cancer Care (ACCC) - Biltmore
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center - Research and Administration at Main Campus
  • California
    • Burbank, California, United States, 91505
      • Providence Saint Joseph Medical Center - Roy and Patricia Disney Family Cancer Center
    • La Jolla, California, United States, 92093
      • University of California San Diego Moores Cancer Center
    • San Francisco, California, United States, 94158
      • USCF Mission Bay
    • Vallejo, California, United States, 94589
      • Kaiser Permanente - Vallejo Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Hartford Hospital
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine
    • Norwalk, Connecticut, United States, 06850
      • Norwalk Hospital
  • Florida
    • Fort Myers, Florida, United States, 33901-8108
      • SCRI - Florida Cancer Specialists - South Region Research Office
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Comprehensive Cancer Center
    • Orlando, Florida, United States, 32806
      • Orlando Health Cancer Institute - Downtown Orlando
    • Sarasota, Florida, United States, 34239
      • Sarasota Memorial Hospital
    • West Palm Beach, Florida, United States, 33401
      • SCRI - Florida Cancer Specialists - West Palm Beach
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital Atlanta
    • Augusta, Georgia, United States, 30912
      • Augusta University Georgia Cancer Center
  • Hawaii
    • Honolulu, Hawaii, United States, 96826
      • Kapi'olani Medical Center for Women and Children
  • Indiana
    • Dyer, Indiana, United States, 46311
      • Northwest Cancer Center - Dyer
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Cancer Center
    • Overland Park, Kansas, United States, 66211
      • HCA Midwest Health
  • Kentucky
    • Edgewood, Kentucky, United States, 41017
      • St. Elizabeth Healthcare - Edgewood
    • Lexington, Kentucky, United States, 40503
      • Baptist Health Lexington
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Sciences Center (LSU Health) - New Orleans
    • Shreveport, Louisiana, United States, 71103
      • Trials365, LLC (Gynecologic Oncology Associates-Shreveport)
  • Maine
    • Scarborough, Maine, United States, 04074-7172
      • Maine Medical Center Cancer Institute- Scarborough
  • Maryland
    • Silver Spring, Maryland, United States, 20910
      • Holy Cross Health - Holy Cross Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Corewell Health (Spectrum Health)
    • Ypsilanti, Michigan, United States, 48197
      • Saint Joseph Mercy Ann Arbor Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center
  • Nevada
    • Reno, Nevada, United States, 89511
      • Center Of Hope
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Comprehensive Cancer Center
  • New York
    • Buffalo, New York, United States, 14203
      • Roswell Park Comprehensive Cancer Center
    • New York, New York, United States, 10032
      • Herbert Irving Comprehensive Cancer Center
    • New York, New York, United States, 10065
      • New York-Presbyterian - Weill Cornell Medical Center
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center - 38th Street
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center at NYU Langone Hospital - Long Island
    • Rochester, New York, United States, 14642
      • James P. Wilmot Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Cancer Institute
    • Pinehurst, North Carolina, United States, 28374
      • FirstHealth Outpatient Cancer Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Main Campus
    • Hilliard, Ohio, United States, 43026
      • JamesCare Gynecologic Oncology at Mill Run
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
    • Portland, Oregon, United States, 97210
      • Legacy Good Samaritan Medical Center
    • Portland, Oregon, United States, 97227
      • USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Rose Quarter Cancer Center
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • St. Luke's University Health Network
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15224
      • Allegheny Health Network - West Penn Hospital
    • Willow Grove, Pennsylvania, United States, 19090
      • Jefferson Health - Asplundh Cancer Pavilion
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Scri Oncology Partners
  • Texas
    • Abilene, Texas, United States, 79606
      • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Abilene
    • Austin, Texas, United States, 78731
      • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Austin Central
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
    • Fort Worth, Texas, United States, 76104
      • USOR - Texas Oncology - Dallas Fort Worth (DFW) - Fort Worth
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Inova Schar Cancer Institute
    • Norfolk, Virginia, United States, 23502
      • USOR - Virginia Oncology Associates - Norfolk
  • Washington
    • Kennewick, Washington, United States, 99336
      • Kadlec Clinic - Hematology and Oncology
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Research Center
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506-9600
      • West Virginia University Cancer Institute
  • Wisconsin
    • Madison, Wisconsin, United States, 53706
      • University of Wisconsin - Madison

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 1.5 years

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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
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 1.5 years
Number of Participants With Treatment-emergent Adverse Events (TEAEs)		Up to approximately 1.5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 23, 2028

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 25, 2024
• First Posted (Actual): October 1, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2026
• Last Update Submitted That Met QC Criteria: August 10, 2026
• Last Verified: August 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; PRO1184-002 (Other Identifier: Other Sponsor Identifier); GOG-3107 (Other Identifier: Other Sponsor Identifier); ENGOT-OV86 (Other Identifier: Other Sponsor Identifier); 2024-514822-21 (Other Identifier: EU Trial (CTIS) Number); jRCT2031250064 (Registry Identifier: Japan Registry for Clinical Trials (jRCT)); CTR20253987 (Other Identifier: Registry ID: 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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No