Recruiting

RAINFOL-03Rinatabart Sesutecan for Endometrial Cancer Post-Chemotherapy

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What is being tested

Rina-S

+ IC

Drug
Who is being recruted

Urogenital Diseases+13

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorGenmab
Study ContactGenmab Trial Information
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 28, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding the best treatment for patients with endometrial cancer, which is a type of cancer that starts in the lining of the uterus. It involves patients whose cancer has returned or continued to grow despite previous treatments with platinum-based chemotherapy and PD(L)-1 therapy. The goal is to see if a new treatment called Rinatabart Sesutecan (Rina-S) is more effective than other commonly used treatments. These treatments include paclitaxel or doxorubicin, which doctors commonly use for this condition. The study is important because it could lead to better treatment options for those who have not responded well to existing therapies. Participants in the study are randomly assigned to receive either the new treatment, Rina-S, or one of the standard treatments chosen by the doctor. The standard treatments are given as either paclitaxel or doxorubicin, based on what the doctor decides is best for each participant before they join the study. The study does not specify how Rina-S is administered, but paclitaxel and doxorubicin are typically given through an IV. By comparing the effectiveness and safety of these treatments, researchers hope to identify which option helps patients live longer or improves their quality of life. The study does not detail any specific risks or benefits, but as with any medical treatment, there might be side effects or varying levels of effectiveness.

Official TitleA 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
NCT07166094
Principal SponsorGenmab
Study ContactGenmab Trial Information
Last updated: February 11, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

544 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SitePathologic ProcessesRecurrencePathological Conditions, Signs and SymptomsUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsEndometrial NeoplasmsDisease AttributesFemale Urogenital Diseases

Criteria

9 inclusion criteria required to participate
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.
Show More Criteria
4 exclusion criteria prevent from participating
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 (eg, 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 (ie, 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 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 15 locations

Recruiting

Trials365, LLC

Shreveport, United StatesOpen Trials365, LLC in Google Maps
Recruiting

Sinai Hospital

Baltimore, United States
Recruiting

William Kahlert Reg. Can. Ctr

Westminster, United States
Recruiting

Willamette Valley Cancer Institute and Research Center - Eugene

Eugene, United States
Recruiting
15 Study Centers