A Phase 3 interventional study of Rina-S and IC in Endometrial Cancer and Recurrent or Progressive Endometrial Cancer, sponsored by Genmab. Recruiting at 178 sites in 19 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Genmab · Phase 3, Interventional, and Treatment
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).
This is a global, open-label, randomized Phase 3 study in approximately 660 participants with recurrent or progressive EC following prior therapy.
Participants will be randomized in a 1:1 ratio to receive treatment with Rina-S vs investigator's choice (IC) (paclitaxel or doxorubicin). Investigators must select one of the IC treatment options for each participant prior to randomization so that this may be used for treatment assignment if the participant is randomized to the IC arm.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 660 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Genmab is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 13 (57%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria
Participants must have received at least 1, but not more than 3, :
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.
Key Exclusion Criteria
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive Rina-S on Day 1 once every 3 weeks (Q3W).
Drug: Rina-S
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.
Drug: IC
Intravenous (IV) infusion.
Also known as: Rinatabart Sesutecan, PRO1184, GEN1184
* Paclitaxel: IV infusion * Doxorubicin: IV bolus injection/infusion
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
Objective Response Rate (ORR), per RECIST v1.1, as Determined by BICR
Time frame: Up to approximately 3 years
PFS, per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
ORR, per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment
Time frame: Up to approximately 3 years
DOR, per RECIST v1.1, as Determined by BICR
Time frame: Up to approximately 3 years
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 3 years
Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)
Time frame: Baseline up to approximately 3 years
Time to Deterioration (TTD) in GHS/Qol
Time frame: Up to approximately 3 years
Showing the first 100 of 178 sites across 19 countries. Choose a country and city above to see the rest.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rinatabart sesutecan