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MBG453

Phase 1

Glioblastoma Multiforme | Small molecule | Oncology |Novartis AG|Last Updated: Apr 23, 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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03961971Trial of Anti-Tim-3 in Combination With Anti-PD-1 and SRS in Recurrent GBMPHASE1 ACTIVE NOT_RECRUITING 16Feb 18, 2020Sep 1, 2026Apr 23, 20262 United States
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Study Endpoints
Primary Endpoints
Number of participants with serious adverse events (SAE) graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) version 5.0
Up to 12 weeks after first dose of study treatment

Number of participants experiencing SAEs, as defined by NCI CTC v5.0

Secondary Endpoints
Proportion of participants who experience grade 3 or higher toxicity, graded according to the NCI CTC v5.0
Up to 100 days after completion of study treatment
Progression-free survival
From the date of initial diagnosis (at surgery) until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Overall survival
From the date of initial diagnosis until the date of death from any cause assessed up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Treatment (MBG453, spartalizumab, stereotactic radiosurgery)EXPERIMENTALPatients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
MBG453DRUGPatients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Patients must provide written informed consent prior to any screening procedures. 2. Age 18 years or older. 3. Willing and able to comply with scheduled visits, treatment plan and laboratory tests 4. Must have WHO Grade IV Glioblastoma or gliosarcoma based on histopathologica...

Countries:United States
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