Recruiting

Phase 3

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

Sponsor:

Genmab

Code:

NCT07166094

Conditions

Endometrial Cancer

Recurrent or Progressive Endometrial Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rina-S

Study Details

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

Study ID

NCT07166094

Start date

Nov 28, 2025

Status verified date

Aug, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria

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

Key Exclusion Criteria

Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.
Has a past or current malignancy other than the inclusion diagnosis before the planned 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 cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration).
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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Design

Enrollment

660 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rina-S

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

active comparator: IC

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.

Interventions

Rina-S

Intravenous (IV) infusion.

Paclitaxel: IV infusion
Doxorubicin: IV bolus injection/infusion

Primary outcome measure

Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 3 years ]
Overall Survival (OS) [ Time Frame: Up to approximately 3 years ]

Central Contacts and Locations

Central contacts

Genmab Trial Information

+4570202728 clinicaltrials@genmab.com

Locations

USAH Mitchell Cancer Inst

Recruiting

Mobile, Alabama, United States, 36604

HonorHealth Research Inst

Recruiting

Phoenix, Arizona, United States, 85016

Kaiser Permanente SoCal

Recruiting

Irvine, California, United States, 92618

CPMC Research Institute

Recruiting

San Francisco, California, United States, 94109

Norwalk Hospital

Recruiting

Danbury, Connecticut, United States, 06810

Norwalk Hospital

Recruiting

Norwalk, Connecticut, United States, 06856

MedStar Washington Hospital

Recruiting

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

SMH - Sarasota - Main Campus

Recruiting

Sarasota, Florida, United States, 34239

Women's Care - 9th Ave

Recruiting

St. Petersburg, Florida, United States, 33713

Women's Care - Armenia Ave

Recruiting

Tampa, Florida, United States, 33603

Emory Winship Cancer Inst.

Recruiting

Atlanta, Georgia, United States, 30308

Emory Winship Cancer Inst.

Recruiting

Atlanta, Georgia, United States, 30322

Northside Hospital Atlanta

Recruiting

Atlanta, Georgia, United States, 30342

Emory Winship Cancer Inst./Emory Decatur Hospital

Recruiting

Decatur, Georgia, United States, 30033

Endeavor Health NorthShore

Recruiting

Evanston, Illinois, United States, 60201

OLOL Cancer Institute

Recruiting

Baton Rouge, Louisiana, United States, 70808

Trials365, LLC

Recruiting

Shreveport, Louisiana, United States, 71103

Sinai Hospital

Recruiting

Baltimore, Maryland, United States, 21215

William Kahlert Reg. Can. Ctr

Recruiting

Westminster, Maryland, United States, 21157

UMass Memorial Medical Ctr

Recruiting

Worcester, Massachusetts, United States, 01605

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

USOR - Minnesota Oncology-Coon Rapids Clinic

Recruiting

Coon Rapids, Minnesota, United States, 55433

USOR - Minnesota Oncology/ Coon Rapids Clinic

Recruiting

Coon Rapids, Minnesota, United States, 55433

USOR - Minnesota Oncology - Edina Clinic

Recruiting

Edina, Minnesota, United States, 55435

USOR - Minnesota Oncology/Edina Clinic

Recruiting

Edina, Minnesota, United States, 55435

USOR - Minnesota Oncology/ Maple Grove Clinic

Recruiting

Maple Grove, Minnesota, United States, 55369

USOR - Minnesota Oncology-Maplewood Clinic

Recruiting

Maplewood, Minnesota, United States, 55109

USOR - Minnesota Oncology/ Maplewood Clinic

Recruiting

Maplewood, Minnesota, United States, 55109

USOR - Minnesota Oncology/ Minneapolis Clinic

Recruiting

Minneapolis, Minnesota, United States, 55404

USOR - Minnesota Oncology

Recruiting

Minneapolis, Minnesota, United States, 55404

USOR - Minnesota Oncology/ Woodbury Clinic

Recruiting

Woodbury, Minnesota, United States, 55125

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Morristown Medical Center

Recruiting

Morristown, New Jersey, United States, 07960

Atlantic Health - Overlook MC

Recruiting

Summit, New Jersey, United States, 07901

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

NYU Laura and Isaac Perlmutter Cancer Center - 34th Street

Recruiting

New York, New York, United States, 10016

Perlmutter CC NYU Langone LI

Recruiting

New York, New York, United States, 11501

Duke Cancer Institute

Recruiting

Durham, North Carolina, United States, 27710

University of Cincinnati Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Willamette Valley Cancer Institute and Research Center - Eugene

Recruiting

Eugene, Oregon, United States, 97401

NW Cancer Specs. P.C.

Recruiting

Happy Valley, Oregon, United States, 97015

USOR - NW Cancer Specs P.C.

Recruiting

Portland, Oregon, United States, 97227

USOR - NW Cancer Specs. P.C.

Recruiting

Tigard, Oregon, United States, 97223

TX Onc - Arlington North

Recruiting

Arlington, Texas, United States, 76012

USOR - Texas Oncology

Recruiting

Austin, Texas, United States, 78731

USOR - Texas Oncology

Recruiting

Austin, Texas, United States, 78745

USOR - Texas Oncology- Austin North

Recruiting

Austin, Texas, United States, 78758

TX Onc - Bedford

Recruiting

Bedford, Texas, United States, 76022

TX Onc - Methodist Dallas

Recruiting

Dallas, Texas, United States, 75203

TX Onc - Presbyterian Dallas

Recruiting

Dallas, Texas, United States, 75231

TX Onc - Methodist Charlton

Recruiting

Dallas, Texas, United States, 75237

TX Onc - Sammons

Recruiting

Dallas, Texas, United States, 75246

USOR - Texas Oncology - Dallas Fort Worth (DFW)

Recruiting

Fort Worth, Texas, United States, 76104

USOR - Texas Oncology

Recruiting

Harlingen, Texas, United States, 78550

USOR - Texas Oncology

Recruiting

McAllen, Texas, United States, 78503

USOR - TX Oncology - SA NE

Recruiting

San Antonio, Texas, United States, 78217

NEXT San Antonio

Recruiting

San Antonio, Texas, United States, 78240

USOR - Texas Oncology- Horizon Circle

Recruiting

Waco, Texas, United States, 76712

USOR - Texas Oncology- Waco

Recruiting

Waco, Texas, United States, 76712

USOR - Texas Oncology

Recruiting

Weslaco, Texas, United States, 78596

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

USOR - NW Cancer Specs P.C.

Recruiting

Vancouver, Washington, United States, 98684

Arthur J E Child Cancer Comp

Recruiting

Calgary, Alberta, Canada, T2N 5G2

BC Cancer - Vancouver

Recruiting

Vancouver, British Columbia, Canada, V5Z 4E6

MUHC - Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

More Information

Sponsor

Genmab

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genmab on 2026-08-17.