Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer

NCT07166094 | Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: GCT1184-03jRCT2031250494MOH_2026-03-29_0157392024-519818-31GOG-3128ENGOT-en31GEICO-158-E
• Study Type: interventional
• Target: 660
• Locations: 10 countries
• Sites: 74

Brief Summary

The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study. The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected. All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).

Conditions

Endometrial Cancer; Recurrent or Progressive Endometrial Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)

  Up to approximately 3 years

• Overall Survival (OS)

  Up to approximately 3 years

Secondary Outcomes (8)

• Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR

  Up to approximately 3 years

• PFS, per RECIST v1.1, as Determined by Investigator Assessment

  Up to approximately 3 years

• ORR, per RECIST v1.1, as Determined by Investigator Assessment

  Up to approximately 3 years

• Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment

  Up to approximately 3 years

• DOR, per RECIST v1.1, as Determined by BICR

  Up to approximately 3 years

Study Arms (2)

Rina-S

EXPERIMENTAL

Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).

Drug: Rina-S

IC

ACTIVE COMPARATOR

Participants will receive one of the following chemotherapies at the discretion of the investigator: * Paclitaxel on Days 1, 8, and 15 every 4 weeks (Q4W). * Doxorubicin on Day 1 Q3W.

Drug: IC

Interventions

Rina-S DRUG

Intravenous (IV) infusion.

Also known as: Rinatabart Sesutecan, PRO1184, GEN1184

Rina-S

IC DRUG

* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion

IC

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 recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy.
• Participants must have received at least 1, but not more than 3, prior lines of therapy:
• Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination
• If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented.
• Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented.
• Prior induction plus maintenance is considered 1 line of therapy
• Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy.
• Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy)
• Participants must have progressed radiographically on or after their most recent line of therapy

You may not qualify if:

• Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
• 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 completion of 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 planned 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 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (74)

MedStar Washington Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

SMH - Sarasota - Main Campus

Sarasota, Florida, 34239, United States

RECRUITING

Women's Care - 9th Ave

St. Petersburg, Florida, 33713, United States

RECRUITING

Emory Winship Cancer Inst.

Atlanta, Georgia, 30308, United States

RECRUITING

Emory Winship Cancer Inst.

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Winship Cancer Inst./Emory Decatur Hospital

Decatur, Georgia, 30033, United States

RECRUITING

Trials365, LLC

Shreveport, Louisiana, 71103, United States

RECRUITING

Sinai Hospital

Baltimore, Maryland, 21215, United States

RECRUITING

William Kahlert Reg. Can. Ctr

Westminster, Maryland, 21157, United States

RECRUITING

USOR - Minnesota Oncology-Coon Rapids Clinic

Coon Rapids, Minnesota, 55433, United States

RECRUITING

USOR - Minnesota Oncology/ Coon Rapids Clinic

Coon Rapids, Minnesota, 55433, United States

RECRUITING

USOR - Minnesota Oncology - Edina Clinic

Edina, Minnesota, 55435, United States

RECRUITING

USOR - Minnesota Oncology/Edina Clinic

Edina, Minnesota, 55435, United States

RECRUITING

USOR - Minnesota Oncology/ Maple Grove Clinic

Maple Grove, Minnesota, 55369, United States

RECRUITING

USOR - Minnesota Oncology-Maplewood Clinic

Maplewood, Minnesota, 55109, United States

RECRUITING

USOR - Minnesota Oncology/ Maplewood Clinic

Maplewood, Minnesota, 55109, United States

RECRUITING

USOR - Minnesota Oncology/ Minneapolis Clinic

Minneapolis, Minnesota, 55404, United States

RECRUITING

USOR - Minnesota Oncology

Minneapolis, Minnesota, 55404, United States

RECRUITING

USOR - Minnesota Oncology/ Woodbury Clinic

Woodbury, Minnesota, 55125, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

RECRUITING

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, Oregon, 97401, United States

RECRUITING

NW Cancer Specs. P.C.

Happy Valley, Oregon, 97015, United States

RECRUITING

USOR - NW Cancer Specs P.C.

Portland, Oregon, 97227, United States

RECRUITING

USOR - NW Cancer Specs. P.C.

Tigard, Oregon, 97223, United States

RECRUITING

TX Onc - Arlington North

Arlington, Texas, 76012, United States

RECRUITING

USOR - Texas Oncology

Austin, Texas, 78731, United States

RECRUITING

USOR - Texas Oncology

Austin, Texas, 78745, United States

RECRUITING

USOR - Texas Oncology- Austin North

Austin, Texas, 78758, United States

RECRUITING

TX Onc - Bedford

Bedford, Texas, 76022, United States

RECRUITING

TX Onc - Methodist Dallas

Dallas, Texas, 75203, United States

RECRUITING

TX Onc - Presbyterian Dallas

Dallas, Texas, 75231, United States

RECRUITING

TX Onc - Methodist Charlton

Dallas, Texas, 75237, United States

RECRUITING

TX Onc - Sammons

Dallas, Texas, 75246, United States

RECRUITING

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Fort Worth, Texas, 76104, United States

RECRUITING

USOR - Texas Oncology

Harlingen, Texas, 78550, United States

RECRUITING

USOR - Texas Oncology

McAllen, Texas, 78503, United States

RECRUITING

USOR - TX Oncology - SA NE

San Antonio, Texas, 78217, United States

RECRUITING

NEXT San Antonio

San Antonio, Texas, 78240, United States

RECRUITING

USOR - Texas Oncology- Horizon Circle

Waco, Texas, 76712, United States

RECRUITING

USOR - Texas Oncology- Waco

Waco, Texas, 76712, United States

RECRUITING

USOR - Texas Oncology

Weslaco, Texas, 78596, United States

RECRUITING

USOR - NW Cancer Specs P.C.

Vancouver, Washington, 98684, United States

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Grand Hôpital de Charleroi

Gilly, Hainaut, 6060, Belgium

RECRUITING

VITAZ

Sint-Niklaas, Sint-Niklaas, 9100, Belgium

RECRUITING

MUHC - Glen Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Kuopio Univ. Hospital, PSHVA

Kuopio, Northern Savonia, 70210, Finland

RECRUITING

Chiba University Hospital- Center for Outpatient

Chiba, Chiba, 260-8677, Japan

RECRUITING

Gunma Prefectural Cancer Center

Ōta, Gunma, 373-8550, Japan

RECRUITING

Iwate Medical University Hosp

Shiwa-gun, Iwate, 028-3695, Japan

RECRUITING

Kitasato University Hospital

Sagamihara-shi, Kanagawa, 252-0373, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Mie University Hospital

Tsu, Kansai, 514-8507, Japan

RECRUITING

NUC Tohoku Univ. Hospital

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Osaka International Cancer Institute - Osaka - Otemae Acti

Osaka, Osaka, 541-8567, Japan

RECRUITING

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka, 411-8777, Japan

RECRUITING

Keio University Hospital

Tokyo, Tokyo, 160-8582, Japan

RECRUITING

National Cancer Center Hospital East

Chiba, 277-8577, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1347, Japan

RECRUITING

Fukushima Medical University Hospital

Fukushima, 960-1247, Japan

RECRUITING

Hyogo Cancer Center

Hyōgo, 673-0021, Japan

RECRUITING

Niigata Cancer Center Hospital

Niigata, Japan

RECRUITING

Saitama Medical University - International Medical Center

Saitama, 350-1298, Japan

RECRUITING

Sapporo Medical University Hospital

Sapporo, 060-8543, Japan

RECRUITING

Osaka Medical and Pharmaceutical University Hospital

Takatsuki, 569-8686, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan

RECRUITING

Yamagata University Hospital

Yamagata, 990-9585, Japan

RECRUITING

OUH Radium Hospital

Oslo, Oslofjord, 0379, Norway

RECRUITING

Haukeland University Hospital

Bergen, Vestland, NO-5021, Norway

RECRUITING

Siedleckie Centrum Onkologii

Siedlce, Masovian Voivodeship, 08-110, Poland

RECRUITING

PR Cancer Specialists

San Juan, 00917, Puerto Rico

RECRUITING

CHU A Coruña

A Coruña, La Coruña, 15006, Spain

RECRUITING

HM Sanchinarro

Madrid, Madrid, 28050, Spain

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: September 9, 2025
• First Posted: September 10, 2025
• Study Start: November 28, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (43); JP (20); CA (1); FI (1); ES (2); BE (2); NO (2); PR (1); PL (1); AU (1)