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GSK5733584

Phase 3

Neoplasms, Endometrial | Small molecule | Oncology |GSK plc|Last Updated: Sep 1, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment610

FDA Designations

No designations recorded

Clinical trial landscape

GSK5733584 · 1 trial · 1 indication

Phase 3 1
NCT07684599A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)Neoplasms, Endometrial
NOT YET_RECRUITING610 Analytics
PHASE3NOT YET_RECRUITING
A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)
Neoplasms, EndometrialUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression free survival (PFS) by BICR assessment
Up to approximately 143 weeks

PFS is defined as the time from the date of randomization to the date of first documented Progressive Disease (PD) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR) assessment or death from any cause, whichever occurs first

Secondary Endpoints

Overall Survival (OS)
Up to approximately 260 weeks
PFS by investigator assessment
Up to approximately 143 weeks
Objective response rate (ORR) by investigator assessment
Up to approximately 260 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mocertatug rezetecan plus physician's choice of immunotherapy (dostarlimab or pembrolizumab)EXPERIMENTALParticipants will receive Mocertatug rezetecan along with physician's choice of immunotherapy (Dostarlimab or Pembrolizumab)
Physician's choice of immunotherapy (dostarlimab or pembrolizumab)ACTIVE_COMPARATORParticipants will receive physician's choice of immunotherapy (Dostarlimab or Pembrolizumab alone)

Interventions

NameTypeDescription
Mocertatug rezetecanDRUGMocertatug rezetecan will be administered
DostarlimabDRUGDostarlimab will be administered
PembrolizumabDRUGPembrolizumab will be administered
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: * Is at least 18 years of age and the legal age of consent in the jurisdiction in which the study is taking place at the time of signing the Informed consent form (ICF). * Has received 6 cycles of first-line therapy (i.e. induction therapy), consisting of platinum-based doublet ...

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Recent Changes (Last 90 Days)

MEDIUMSep 1, 2026NCT07684599lastUpdatePostDate: changed
MEDIUMSep 1, 2026NCT07684599lastUpdatePostDate: changed
LOWJul 15, 2026NCT07684599lastUpdatePostDate: changed
LOWJul 15, 2026NCT07684599lastUpdatePostDate: changed
LOWJul 6, 2026NCT07684599NEW_TRIAL: changed
LOWJul 6, 2026NCT07684599NEW_TRIAL: changed

Frequently asked questions about GSK5733584

What is GSK5733584 used for?

GSK5733584 is an investigational small molecule being studied for the treatment of endometrial neoplasms, specifically in patients with mismatch repair proficient (MMRp) endometrial cancer. It is currently in Phase 3 clinical development as a maintenance treatment for this condition.

Who makes GSK5733584?

GSK5733584 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting a Phase 3 clinical trial to evaluate the drug as a maintenance treatment for endometrial cancer.

What phase is GSK5733584 in?

GSK5733584 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is designed to evaluate its efficacy and safety as a maintenance treatment for patients with MMRp endometrial cancer.

What clinical trials is GSK5733584 in?

GSK5733584 is being studied in a Phase 3 clinical trial with the identifier NCT07684599. This trial, titled 'A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)', is not yet recruiting and aims to enroll 610 female participants aged 18 years and older.

Is GSK5733584 the same as Mocertatug Rezetecan?

Yes, GSK5733584 is also known as Mocertatug Rezetecan. The Phase 3 clinical trial NCT07684599 uses the name Mocertatug Rezetecan to refer to the drug being investigated as a maintenance treatment for participants with MMRp endometrial cancer.