Study of Rina-S for Recurrent or Progressive Endometrial Cancer
This study is testing a drug called Rina-S to see how well it works and if it's safe for people with recurrent or progressive endometrial cancer (a type of uterine cancer) that has returned or worsened after previous treatments. Rina-S is an antibody-drug conjugate, which is a type of immunotherapy. You would have an equal chance (50%) of receiving Rina-S or a standard chemotherapy drug like paclitaxel or doxorubicin, chosen by your doctor. The study aims to see if Rina-S can help you live longer without your cancer getting worse, and how long you live overall. To join, you must be a woman aged 18 or older with this type of endometrial cancer who has had 1 to 3 prior treatments, including platinum-based therapy. The study is currently recruiting participants.
- Study design
- This is a global, open-label (meaning you and your doctors will know which treatment you are receiving), randomized Phase 3 study involving about 660 participants.
- What's involved
- Participation will involve visits to study sites for approximately 3 years, with an average treatment duration of 4 to 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for up to approximately 3 years to measure how long you live without your cancer getting worse and your overall survival.
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NCT07166094
Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentGenmab
~660 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Rina-SIC
At a glance
Recruiting sites
160 of 160 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free Survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by Blinded Independent Central Review (BICR)
Measured over Up to approximately 3 years
+1 more outcome measured
Conditions
Where it's being run
160 sites across 96 statesTexas17
Minnesota10
Japan10
Georgia4
Oregon4
Spain4
Florida3
New Jersey3
Study leadership
- Study Official · STUDY_DIRECTOR · Genmab
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
Exclusion
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.
What this trial measures
- 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