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Clinical Trials in the USA / NCT07166094
Recruiting Phase 3

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

NCT07166094 · tracked via the Priya Life Science USA tracker
Sponsor
Genmab
Phase
Phase 3
Started
2025-11-28
Last updated
2026-09-09

Condition(s) studied

Endometrial CancerRecurrent or Progressive Endometrial Cancer

Investigational drug(s) / intervention(s)

Rina-S →IC

Rina-S: Intravenous (IV) infusion.

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

Study 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).

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (171)

FacilityCityRegionStatus
USAH Mitchell Cancer Inst Mobile Alabama Recruiting
HonorHealth Research Inst Phoenix Arizona Recruiting
Kaiser Permanente SoCal Irvine California Recruiting
CPMC Research Institute San Francisco California Recruiting
Norwalk Hospital Danbury Connecticut Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Norwalk Hospital Norwalk Connecticut Recruiting
MedStar Washington Hospital Washington D.C. District of Columbia Recruiting
SMH - Sarasota - Main Campus Sarasota Florida Recruiting
Women's Care - 9th Ave St. Petersburg Florida Recruiting
Women's Care - Armenia Ave Tampa Florida Recruiting
Emory Winship Cancer Inst. Atlanta Georgia Recruiting
Emory Winship Cancer Inst. Atlanta Georgia Recruiting
Northside Hospital Atlanta Atlanta Georgia Recruiting
Emory Winship Cancer Inst./Emory Decatur Hospital Decatur Georgia Recruiting
Endeavor Health NorthShore Evanston Illinois Recruiting
OLOL Cancer Institute Baton Rouge Louisiana Recruiting
Trials365, LLC Shreveport Louisiana Recruiting
Sinai Hospital Baltimore Maryland Recruiting
William Kahlert Reg. Can. Ctr Westminster Maryland Recruiting
UMass Memorial Medical Ctr Worcester Massachusetts Recruiting
Corewell Health Grand Rapids Michigan Recruiting
USOR - Minnesota Oncology-Coon Rapids Clinic Coon Rapids Minnesota Recruiting
USOR - Minnesota Oncology/ Coon Rapids Clinic Coon Rapids Minnesota Recruiting
USOR - Minnesota Oncology - Edina Clinic Edina Minnesota Recruiting
USOR - Minnesota Oncology/Edina Clinic Edina Minnesota Recruiting
USOR - Minnesota Oncology/ Maple Grove Clinic Maple Grove Minnesota Recruiting
USOR - Minnesota Oncology-Maplewood Clinic Maplewood Minnesota Recruiting
USOR - Minnesota Oncology/ Maplewood Clinic Maplewood Minnesota Recruiting
USOR - Minnesota Oncology/ Minneapolis Clinic Minneapolis Minnesota Recruiting
USOR - Minnesota Oncology Minneapolis Minnesota Recruiting
USOR - Minnesota Oncology/ Woodbury Clinic Woodbury Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Morristown Medical Center Morristown New Jersey Recruiting
Atlantic Health - Overlook MC Summit New Jersey Recruiting
Holy Name Medical Center Teaneck New Jersey Recruiting
NYU Laura and Isaac Perlmutter Cancer Center - 34th Street New York New York Recruiting
Perlmutter CC NYU Langone LI New York New York Recruiting
Atrium Health LCI - Morehead Charlotte North Carolina Recruiting
Atrium Health LCI - Ballantyne Charlotte North Carolina Recruiting

+ 131 more sites — see the full list on the official registry below.

More Genmab trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07166094 on ClinicalTrials.gov ↗ ← All trials in the USA