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VAL-083

Phase 2

Glioma | Small molecule | Oncology |TuHURA Biosciences, Inc.|Last Updated: Sep 4, 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
CONTROLLEDBiomarker
Total Trials3
Total Enrollment202
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03050736Safety Study of VAL-083 and Radiotherapy in Patients With Newly Diagnosed GBM Having Unmethylated MGMT ExpressionPHASE2 COMPLETED 29 — — Dec 17, 2017Dec 30, 2024Sep 4, 20251 China
NCT02717962Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Glioblastoma in the Adjuvant or Recurrent SettingPHASE2 COMPLETED 118 — — Jan 20, 2017Dec 30, 2024Aug 29, 20251 United States
NCT01478178Safety Study of VAL-083 in Patients With Recurrent Malignant GliomaPHASE1 COMPLETED 55 — — Oct 1, 2011Oct 1, 2016Aug 29, 20255 United States
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Study Endpoints
Primary Endpoints
Efficacy evaluation of tumor response in patients, as measured by magnetic resonance imaging
Every 42 days while receiving radiotherapy then every 63 days while remaining on study, from patient randomization until study discontinuation for up to 10 months

Tumor response assessment via MRI, as long as patient continues to demonstrate response or stable disease and tolerates therapy.

Overall Survival
Every 30 days from randomization until patient death

Length of time from start of treatment (Day 1) until patient death

Determination of maximum tolerated dose (MTD)
Study Day 35

The determination of MTD will be based on analysis of tolerance data from the first cycle of therapy in each dose group.

Secondary Endpoints
Safety evaluation of VAL-083 in combination with a standard radiation therapy, as determined by incidence of patient adverse events and changes in laboratory results, ECG and vital signs
Every 30 days, from patient randomization through 28 days following last study treatment for up to 10 months
Ctrough
On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
Cmax
On Cycle 1 Day 1 pre-dose, and 15, 30, 60, 120, 240 and 360 minutes after study drug administration then Cycle 1 Day 2 pre-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
VAL-083 (Dianhydrogalactitol)EXPERIMENTALVAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
VAL-083, Dianhydrogalactitol (Group 1)EXPERIMENTALPatients with recurrent/progressive GBM
VAL-083, Dianhydrogalactitol (Group 2)EXPERIMENTALNewly diagnosed GBM patients who have completed chemoradiation treatment with temozolomide and received no subsequent maintenance temozolomide
Interventions
NameTypeDescription
VAL-083 (Dianhydrogalactitol)DRUGVAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
VAL-083, DianhydrogalactitolDRUGThe dosing regimen for patients will be VAL-083 (30 mg/m2) administered IV for 3 consecutive days at the beginning of every 21-day cycle. Patients will continue to receive VAL 083, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation.
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Eligibility Criteria
Age Range18 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Newly diagnosed histologically proven supratentorial GBM 2. Tumor tissue specimens from the GBM surgery or open biopsy must be available for MGMT gene promoter status analysis and central pathology review. 3. Documented unmethylated MGMT gene promoter status 4. Males or femal...

Countries:ChinaUnited States
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