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STAT3 Inhibitor WP1066

Phase 2

Glioblastoma, IDH-Wildtype | Small molecule | Oncology |Moleculin Biotech, Inc.|Last Updated: Dec 30, 2025

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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment39
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05879250WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed GlioblastomaPHASE2 RECRUITING 39 — — May 22, 2024Dec 27, 2028Dec 30, 20252 United States
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Study Endpoints
Primary Endpoints
Progression-Free Survival (PFS) (Cohort 1)
From subject registration to the earlier of the day of first documented disease progression or death from any cause, assessed up to 36 months post-registration

For PFS analysis, disease progression is defined as progressive disease (PD) per Response Assessment in Neuro-Oncology (RANO) criteria Will be summarized using the Kaplan-Meier method.

Tumor microenvironment activation and cluster interactions (Cohort 2)
Up to 36 months post-registration
Secondary Endpoints
Overall Survival (OS)
From the date of initial diagnosis until death from any cause, assessed up to 36 months
Overall Response Rate (ORR)
Up to 36 months post-registration
Duration of response (DOR)
Up to 36 months post-registration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort I (WP1066, radiation)EXPERIMENTALPatients whose tumor was completely removed at the time of initial surgery receive WP1066 PO for 6 weeks during routine radiation therapy, and then for twelve 28-day cycles on study. Patients also undergo MRI and collection of blood samples throughout the trial.
Cohort II (WP1066, radiation, surgery)EXPERIMENTALPatients whose tumor was not fully removed at the time of initial surgery receive WP1066 PO for 6 weeks during routine radiation therapy on study. Patients may then undergo possible surgery or open biopsy if eligible, followed by twelve 28-day cycles of WP1066 PO on study. Patients also undergo MRI and collection of blood samples throughout the trial.
Interventions
NameTypeDescription
Biospecimen CollectionPROCEDUREUndergo collection of blood
Magnetic Resonance ImagingPROCEDUREUndergo MRI
Radiation TherapyRADIATIONUndergo routine radiation therapy
STAT3 Inhibitor WP1066DRUGGiven PO
Surgical ProcedurePROCEDUREUndergo removal or biopsy of tumor
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Newly diagnosed, histologically confirmed World Health Organization (WHO) glioblastoma multiforme (GBM), IDH wild-type * External pathology reports are permitted for confirmation of histological diagnosis * Documentation of isocitrate dehydrogenase (IDH) wild-type status ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05879250primaryCompletionDate: changed
LOWMay 24, 2026NCT05879250studyFirstPostDate: changed