RINATABART SESUTECAN for Endometrial cancer | Recurrent endometrial cancer | Metastatic endometrial cancer

Inclusion criteria

• {"criterion_text":"- 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.\n- Participants must have received at least 1, but not more than 3, prior lines of therapy:\n- Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination\n- 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 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.\n- Prior induction plus maintenance is considered 1 line of therapy\n- Hormonal therapy alone (ie, without chemotherapy) will not be counted as a separate line of therapy.\n- 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)\n- Participants must have progressed radiographically on or after their most recent line of therapy"}

Exclusion criteria

• {"criterion_text":"- Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n- 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).\n- 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.\n- 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"}

Primary endpoints

• {"endpoint_text":"- 1. Progression-free survival (PFS) per Response Criteria in Solid Tumors (RECIST) v1.1, as Determined by independent central review (BICR) [Time Frame: Up to approximately 3 years]","definition_or_measurement_approach":"PFS per RECIST v1.1 assessed by blinded independent central review (BICR); time frame up to ~3 years."}
• {"endpoint_text":"- 2. Overall Survival (OS) [Time Frame: Up to approximately 3 years]","definition_or_measurement_approach":"Overall survival measured from randomisation to death from any cause; time frame up to ~3 years."}

Secondary endpoints

• {"endpoint_text":"- Objective Response Rate (ORR), per RECIST v1.1, as Determined by BIRC","definition_or_measurement_approach":"ORR per RECIST v1.1 determined by blinded independent review (BICR/BIRC)."}
• {"endpoint_text":"- PFS, per RECIST v1.1, as determined by investigator assessment","definition_or_measurement_approach":"PFS per RECIST v1.1 determined by investigator assessment."}
• {"endpoint_text":"- ORR, per RECIST v1.1, as Determined by investigator assessment","definition_or_measurement_approach":"ORR per RECIST v1.1 determined by investigator assessment."}
• {"endpoint_text":"- Duration of Objective Response (DOR), per RECIST v1.1, as Determined by Investigator Assessment","definition_or_measurement_approach":"DOR per RECIST v1.1 determined by investigator assessment."}
• {"endpoint_text":"- DOR, per RECIST v1.1, as Determined by BICR","definition_or_measurement_approach":"DOR per RECIST v1.1 determined by blinded independent central review (BICR)."}
• {"endpoint_text":"- Number of Participants with Treatment-emergent Adverse Events (TEAEs)","definition_or_measurement_approach":"Count and characterization of treatment-emergent adverse events reported during treatment."}
• {"endpoint_text":"- Change from Baseline in Global Health Status/Quality of Life (GHS/Qol)","definition_or_measurement_approach":"Change from baseline in patient-reported global health status/quality of life (GHS/QoL) measures."}
• {"endpoint_text":"- Time to Deterioration (TTD) in GHS/Qol","definition_or_measurement_approach":"Time to deterioration in global health status/quality of life (TTD) as measured by PRO instruments."}

Methods

• Country-specific Recruitment Procedure (K1) documents available (e.g., K1_DE, K1_NO, K1_EL, K1_LT, K1_PL, K1_IT, K1_DK, K1_FI, K1_BE, K1_ES, K1_FR) describing local recruitment workflow and channels.
• Physician-to-Physician letters (K2 documents) to referring physicians (explicit K2 entries present for Greece, Italy, Lithuania, Poland, Denmark, France, Spain, Belgium and others) — channel: direct letter to physicians; target audience: treating/referring clinicians.
• General Practitioner letters (K2) in some countries (e.g., Italy K2_IT, Lithuania K2_LT, Greece K2_EL) — channel: mailed or emailed letters to GPs to raise awareness and refer eligible patients.
• Subject Participation Cards / Subject Card (L2) in some countries (e.g., Greece L2_EL, Lithuania L2_LT) — channel: paper card given to potential participants; target audience: patients.
• Email communication materials (L2) — e.g., L2_LT_Email Communication_Lithuanian is provided (channel: email to potential participants or patient-facing contacts in Lithuania).
• ScoutPass materials (L2) in Lithuania (ScoutPass Mastercard, ScoutPass FAQ, Scout Brochure) — channel: digital/printed patient support and enrollment materials to support recruitment and participation.

Norway

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

17

Number Of Participants

10

Greece

Earliest CTIS Part Ii Submission Date

09-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

49

Number Of Participants

12

Lithuania

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

26-03-2026

Processing Time Days

27

Number Of Participants

10

Poland

Earliest CTIS Part Ii Submission Date

11-03-2026

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

27

Number Of Participants

29

Italy

Earliest CTIS Part Ii Submission Date

30-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

23

Number Of Participants

32

Denmark

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

15

Number Of Participants

10

Finland

Earliest CTIS Part Ii Submission Date

20-03-2026

Latest Decision Or Authorization Date

02-04-2026

Processing Time Days

13

Number Of Participants

10

Belgium

Earliest CTIS Part Ii Submission Date

26-03-2026

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

18

Number Of Participants

12

Germany

Earliest CTIS Part Ii Submission Date

04-03-2026

Latest Decision Or Authorization Date

27-03-2026

Processing Time Days

23

Number Of Participants

31

Spain

Earliest CTIS Part Ii Submission Date

17-03-2026

Latest Decision Or Authorization Date

15-04-2026

Processing Time Days

29

Number Of Participants

35

France

Earliest CTIS Part Ii Submission Date

09-02-2026

Latest Decision Or Authorization Date

30-03-2026

Processing Time Days

49

Number Of Participants

35

Primary sponsor

Full Name

Genmab A/S

Organisation Type

Pharmaceutical company

Country Of Registered Address

Denmark

Contract research organisations

Name

PRA Hellas CRO A.E.

Responsibilities

CRO

Third parties

• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Sponsor duties codes: 1,12,13,14,15 (Analytical lab (PK-ADC and PL)),4,5,6,7,8; contact: ICONRegulatoryCTIS@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 7; contact: helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Provides central lab services, ctDNA processing, storage of biomarker and PK/ADA samples, and prospective FRa analysis; contact: investigatorservices@q2labsolutions.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Analytical lab (ADA, PK-TAb); contact: info@bioagilytix.com","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"Sponsor duties code: 3; contact: info@4gclinical.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug depot - Europe; contact: clinicalservices@almacgroup.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient supporting; contact: info@scoutclinical.com","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"Analysis for ctDNA; contact: biopharma_samples@guardanthealth.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"Sponsor duties including CRO functions (listed as 'CRO' in duties); contact: ICONRegulatoryCTIS@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Independent statistical group (IDMC); contact: info@wcgclinical.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging; contact: madhavi.neela@perceptive.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"FRα expression and biomarkers analysis; contact: info@ventanamed.com","organisation_type":"Pharmaceutical company"}