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Mocertatug rezetecan

Phase 3

Neoplasms, Endometrial | Small molecule | Oncology |GSK plc|Last Updated: Sep 3, 2026

Target and mechanism

ModalitySmall molecule

Also known as Mocertatug rezetecan (Mo-Rez)

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,210

FDA Designations

No designations recorded

Clinical trial landscape

Mocertatug rezetecan · 6 trials · 4 indications

Phase 3 5Phase 1 1
NCT07694427Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]Ovarian Neoplasms
NOT YET_RECRUITING720 Analytics
NCT07684612A Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-sensitive Ovarian Cancer (BEHOLD-Ovarian02)Ovarian Neoplasms
NOT YET_RECRUITING690 Analytics
NCT07684599A Study to Investigate Mocertatug Rezetecan as Maintenance Treatment for Participants With MMRp Endometrial Cancer (BEHOLD-Endometrial02)Neoplasms, Endometrial
NOT YET_RECRUITING610 Analytics
NCT07286266A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)Ovarian Neoplasms
RECRUITING450 Analytics
NCT07286331A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)Neoplasms, Endometrial
RECRUITING600 Analytics
PHASE3NOT YET_RECRUITING
Mo-Rez in First- Line (1L) Maintenance Treatment of Non-Homologous Recombination Deficient Ovarian Cancer (Non-HRd OC) [BEHOLD-Ovarian03]
Ovarian NeoplasmsUnlock trial analytics
PHASE3NOT YET_RECRUITING
A Study to Investigate Mocertatug Rezetecan With Bevacizumab Compared With Platinum Doublet With Bevacizumab in Participants With Platinum-sensitive Ovarian Cancer (BEHOLD-Ovarian02)
Ovarian NeoplasmsUnlock trial 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
PHASE3RECRUITING
A Study to Investigate Mocertatug Rezetecan Compared With Standard of Care in Participants With Platinum-resistant Ovarian Cancer (BEHOLD-Ovarian01)
Ovarian NeoplasmsUnlock trial analytics
PHASE3RECRUITING
A Study to Investigate Mocertatug Rezetecan Compared With Chemotherapy in Participants With Endometrial Cancer After Platinum-based Chemotherapy and Immunotherapy (BEHOLD-Endometrial01)
Neoplasms, EndometrialUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS)
Up to approximately 34 months

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

Progression Free Survival (PFS) by BICR
Up to approximately 191 weeks

PFS is defined as the time from the date of randomization to the date of first documented disease progression (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.

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

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

Objective response rate (ORR) by BICR
Up to approximately 97 weeks

ORR is defined as the percentage of participants with best overall confirmed response of either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) by Blinded independent central review (BICR)

Part 1: Number of participants with dose limiting toxicity (DLT)
Up to 21 days
Part 2-Confirmed Objective Response Rate (ORR) assessed by investigator
Up to approximately 28 months

ORR is defined as the proportion of participants with at least one confirmed Complete Response (CR) or Partial Response (PR) as defined by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Endpoints

Overall Survival (OS)
Up to approximately 72 months
PFS by investigator assessment
Up to approximately 72 months
Time to first subsequent therapy (TFST)
Up to approximately 72 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Mocertatug rezetecan +/- BevacizumabEXPERIMENTAL -
Active Observation +/- BevacizumabACTIVE_COMPARATOR -
Mocertatug rezetecan (Mo-Rez) + BevacizumabEXPERIMENTALParticipants will receive Mo-Rez + bevacizumab.
Platinum doublet + BevacizumabACTIVE_COMPARATORParticipants will receive platinum doublet chemotherapy (carboplatin with paclitaxel, gemcitabine, or pegylated liposomal doxorubicin \[PLD\]) and bevacizumab, followed by bevacizumab maintenance therapy.
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)
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
Part 1: Dose EscalationEXPERIMENTALParticipants with advanced solid tumors who are refractory or intolerant to established standard therapies
Part 2: Dose ExpansionEXPERIMENTALParticipants with platinum-resistant ovarian cancer (PROC) and endometrial cancer (EC)

Interventions

NameTypeDescription
Mocertatug rezetecanDRUGMocertatug rezetecan will be administered
BevacizumabDRUGBevacizumab will be administered
Mocertatug rezetecan (Mo-Rez)DRUGMocertatug rezetecan will be administered
CarboplatinDRUGCarboplatin will be administered
PaclitaxelDRUGPaclitaxel will be administered
GemcitabineDRUGGemcitabine will be administered
Pegylated liposomal doxorubicin (PLD)DRUGPLD will be administered
DostarlimabDRUGDostarlimab will be administered
PembrolizumabDRUGPembrolizumab will be administered
TopotecanDRUGTopotecan will be administered
DoxorubicinDRUGDoxorubicin will be administered
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * 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 new...

Countries:JapanAustraliaCanadaArgentinaBrazilPanamaUnited StatesBelgiumFinlandFranceItalyNetherlandsSouth KoreaSpainSwedenUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 3, 2026NCT07684612lastUpdatePostDate: changed
LOWSep 3, 2026NCT07684612lastUpdatePostDate: changed
MEDIUMSep 1, 2026NCT07684599lastUpdatePostDate: changed
MEDIUMSep 1, 2026NCT07684599lastUpdatePostDate: changed
LOWAug 31, 2026NCT07286331lastUpdatePostDate: changed
LOWAug 31, 2026NCT07286331lastUpdatePostDate: changed
LOWAug 6, 2026NCT07694427lastUpdatePostDate: changed
LOWAug 6, 2026NCT07694427lastUpdatePostDate: changed
LOWJul 15, 2026NCT07286331lastUpdatePostDate: changed
LOWJul 15, 2026NCT07286266primaryCompletionDate: changed
LOWJul 15, 2026NCT07684599lastUpdatePostDate: changed
LOWJul 15, 2026NCT07684612lastUpdatePostDate: changed
LOWJul 15, 2026NCT07694427lastUpdatePostDate: changed
LOWJul 15, 2026NCT07286331lastUpdatePostDate: changed
LOWJul 15, 2026NCT07286266primaryCompletionDate: changed
LOWJul 15, 2026NCT07684612lastUpdatePostDate: changed
LOWJul 15, 2026NCT07684599lastUpdatePostDate: changed
LOWJul 15, 2026NCT07694427lastUpdatePostDate: changed
LOWJul 10, 2026NCT07694427NEW_TRIAL: changed
LOWJul 10, 2026NCT07694427NEW_TRIAL: changed

Frequently asked questions about Mocertatug rezetecan

What is Mocertatug rezetecan used for?

Mocertatug rezetecan is an investigational small molecule being studied for the treatment of ovarian cancer, endometrial cancer, and other solid tumors. It is being evaluated in Phase 3 clinical trials for platinum-resistant ovarian cancer, platinum-sensitive ovarian cancer, and endometrial cancer after prior platinum-based chemotherapy and immunotherapy.

Who is developing Mocertatug rezetecan?

Mocertatug rezetecan is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. The company is sponsoring multiple Phase 3 clinical trials to investigate the drug's efficacy and safety in various oncology indications.

What phase is Mocertatug rezetecan in?

Mocertatug rezetecan is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trials are designed to compare the drug with standard of care treatments in patients with ovarian and endometrial cancers.

What clinical trials is Mocertatug rezetecan in?

Mocertatug rezetecan is being studied in several Phase 3 trials, including NCT07286266 for platinum-resistant ovarian cancer, NCT07286331 for endometrial cancer, NCT07684612 for platinum-sensitive ovarian cancer, and NCT07694427 for first-line maintenance treatment of non-homologous recombination deficient ovarian cancer. These trials are actively recruiting or planned.

Is Mocertatug rezetecan the same as Mo-Rez?

Yes, Mocertatug rezetecan is also known as Mo-Rez. The abbreviation Mo-Rez is used in clinical trial titles and refers to the same investigational drug. Researchers and clinicians may refer to the drug by either name in publications and trial documentation.

How does Mocertatug rezetecan work?

Mocertatug rezetecan is a small molecule being investigated for its anticancer activity. The specific molecular target has not been disclosed in the available clinical trial information. The drug is being evaluated in patients with ovarian cancer, endometrial cancer, and other solid tumors to determine its efficacy and safety.