🔎 Trials Near Me

Home › Endometrial Cancer › NCT07166094

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

RecruitingPhase 3

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

Who can join

Ages 18 and older · Women

Full eligibility criteria
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.

About the study

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).

What is being tested

Sponsor: Genmab · Participants: 660 · Started: Nov 28, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07166094

Locations in the U.S.

AlabamaUSAH Mitchell Cancer Inst, Mobile
ArizonaHonorHealth Research Inst, Phoenix
CaliforniaKaiser Permanente SoCal, Irvine
CPMC Research Institute, San Francisco
ConnecticutNorwalk Hospital, Danbury
Hartford Hospital, Hartford
Norwalk Hospital, Norwalk
District of ColumbiaMedStar Washington Hospital, Washington D.C.
FloridaSMH - Sarasota - Main Campus, Sarasota
Women's Care - 9th Ave, St. Petersburg
Women's Care - Armenia Ave, Tampa
GeorgiaEmory Winship Cancer Inst., Atlanta
Emory Winship Cancer Inst., Atlanta
Northside Hospital Atlanta, Atlanta
Emory Winship Cancer Inst./Emory Decatur Hospital, Decatur
IllinoisEndeavor Health NorthShore, Evanston
LouisianaOLOL Cancer Institute, Baton Rouge
Trials365, LLC, Shreveport
MarylandSinai Hospital, Baltimore
William Kahlert Reg. Can. Ctr, Westminster
MassachusettsUMass Memorial Medical Ctr, Worcester
MichiganCorewell Health, Grand Rapids
MinnesotaUSOR - Minnesota Oncology-Coon Rapids Clinic, Coon Rapids
USOR - Minnesota Oncology/ Coon Rapids Clinic, Coon Rapids
USOR - Minnesota Oncology - Edina Clinic, Edina
USOR - Minnesota Oncology/Edina Clinic, Edina
USOR - Minnesota Oncology/ Maple Grove Clinic, Maple Grove
USOR - Minnesota Oncology-Maplewood Clinic, Maplewood
USOR - Minnesota Oncology/ Maplewood Clinic, Maplewood
USOR - Minnesota Oncology, Minneapolis
USOR - Minnesota Oncology/ Minneapolis Clinic, Minneapolis
USOR - Minnesota Oncology/ Woodbury Clinic, Woodbury
MissouriWashington University School of Medicine, St Louis
New JerseyMorristown Medical Center, Morristown
Atlantic Health - Overlook MC, Summit
Holy Name Medical Center, Teaneck
New YorkNYU Laura and Isaac Perlmutter Cancer Center - 34th Street, New York
Perlmutter CC NYU Langone LI, New York
North CarolinaAtrium Health LCI - Ballantyne, Charlotte
Atrium Health LCI - Morehead, Charlotte
Atrium Health LCI - Concord, Concord
Duke Cancer Institute, Durham
Atrium Health LCI - Gaston, Gastonia
Wake Forest University, Winston-Salem
OhioUniversity of Cincinnati Medical Center, Cincinnati
OregonWillamette Valley Cancer Institute and Research Center - Eugene, Eugene
NW Cancer Specs. P.C., Happy Valley
USOR - NW Cancer Specs P.C., Portland
USOR - NW Cancer Specs. P.C., Tigard
TexasTX Onc - Arlington North, Arlington
USOR - Texas Oncology, Austin
USOR - Texas Oncology, Austin
USOR - Texas Oncology- Austin North, Austin
TX Onc - Bedford, Bedford
TX Onc - Methodist Charlton, Dallas
TX Onc - Methodist Dallas, Dallas
TX Onc - Presbyterian Dallas, Dallas
TX Onc - Sammons, Dallas
USOR - Texas Oncology - Dallas Fort Worth (DFW), Fort Worth
USOR - Texas Oncology, Harlingen
USOR - Texas Oncology, McAllen
NEXT San Antonio, San Antonio
USOR - TX Oncology - SA NE, San Antonio
USOR - Texas Oncology- Horizon Circle, Waco
USOR - Texas Oncology- Waco, Waco
USOR - Texas Oncology, Weslaco
VirginiaUniversity of Virginia, Charlottesville
WashingtonUSOR - NW Cancer Specs P.C., Vancouver

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.