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Mocertatug rezetecan

Phase 3

Ovarian Neoplasms | Small molecule | Oncology |GSK plc|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment450
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07286266A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)PHASE3 NOT YET_RECRUITING 450Jun 24, 2026Aug 21, 2030May 27, 2026 -
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS) by BICR
Up to approximately 212 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.

Overall Survival (OS)
Up to approximately 212 weeks

OS is defined as the time from the date of randomization to the date of death due to any cause

Secondary Endpoints
PFS by investigator assessment
Up to approximately 212 weeks
Objective response rate (ORR) by BICR
Up to approximately 212 weeks
Duration of Response (DOR) by BICR
Up to approximately 212 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mocertatug rezetecanEXPERIMENTALParticipants will receive Mocertatug rezetecan
Standard of careACTIVE_COMPARATORParticipants will receive standard of care chemotherapy (Paclitaxel or Pembrolizumab + paclitaxel ± bevacizumab or PLD or Topotecan or Gemcitabine) as per investigator's choice
Interventions
NameTypeDescription
Mocertatug rezetecanDRUGMocertatug rezetecan will be administered
PaclitaxelDRUGPaclitaxel will be administered
Pegylated liposomal doxorubicin (PLD)DRUGPLD will be administered
TopotecanDRUGTopotecan will be administered
GemcitabineDRUGGemcitabine will be administered
PembrolizumabDRUGPembrolizumab will be administered
BevacizumabDRUGBevacizumab will be administered
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Eligibility Criteria
Age Range18 Years — 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 epithelial ovarian cancer, inclusive of primary peritoneal or fallopian-tube cancer with a histological...

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Recent Changes (Last 90 Days)
MEDIUMMay 28, 2026NCT07286266primaryCompletionDate: changed
MEDIUMMay 28, 2026NCT07286266primaryCompletionDate: changed
LOWMay 26, 2026NCT07286266primaryCompletionDate: changed
LOWMay 24, 2026NCT07286266studyFirstPostDate: changed