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Risvutatug rezetecan

Phase 1

Glioblastoma (GBM) | Small molecule | Oncology |GSK plc|Last Updated: Mar 6, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07268053A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain MetastasesEARLY_PHASE1 RECRUITING 15 — — Feb 11, 2026Jul 1, 2029Mar 6, 20261 United States
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Study Endpoints
Primary Endpoints
Phase 0: Total, Cleaved, and Unbound GSK5757810 Payload Concentration in Tumor Tissue
Intraoperatively

The total, cleaved, and unbound GSK5757810 payload concentration in Gd enhancing and Gd non-enhancing tumor tissue collected during Phase 0 surgery from participants with rGBM, and Gd enhancing tumor tissue collected during Phase 0 surgery from participants with brain metastases, will be determined.

Phase 1: Incidence of Adverse Events as Assessed by CTCAE v5.0
Date of first infusion until 90-days post last infusion

Incidence of the following will be summarized: AEs, SAEs, and AEs of Special Interest (AESIs); treatment discontinuations, dose interruptions, and dose reductions due to AEs; changes in vital signs, body weight, laboratory tests, ECG, and ECOG performance status

Secondary Endpoints
Phase 0: Total, Cleaved, and Unbound GSK5757810 Payload Concentration in CSF
Intraoperatively
Phase 0: pH2AX and B7-H3 Expression Change in Tumor Tissue
Intraoperatively, archival
Phase 1: Progression-Free Survival at 6 Months (PFS6)
Date of first infusion to the date of disease recurrence or death due to any cause (whichever occurs first), assessed up to 6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
rGBM and Brain MetsEXPERIMENTALGroup A will include participants with recurrent WHO Grade 4 glioma (rGBM) and group B will include participants with brain metastases (brain mets)
Interventions
NameTypeDescription
Risvutatug rezetecanDRUGRisvutatug rezetecan will be administered intravenously.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Diagnosed with: (a) GBM according to the 2021 WHO criteria, who have progressed on or following standard of care therapy, including maximal safe resection (biopsy allowed if resection was deemed unsafe) and concurrent chemoradiation; OR (b) Brain metastasis requiring surgi...

Countries:United States
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