Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
VAL-083 · 3 trials · 5 indications
Tumor response assessment via MRI, as long as patient continues to demonstrate response or stable disease and tolerates therapy.
Length of time from start of treatment (Day 1) until patient death
The determination of MTD will be based on analysis of tolerance data from the first cycle of therapy in each dose group.
| Arm | Type | Description |
|---|---|---|
| VAL-083 (Dianhydrogalactitol) | EXPERIMENTAL | VAL-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) | EXPERIMENTAL | Patients with recurrent/progressive GBM |
| VAL-083, Dianhydrogalactitol (Group 2) | EXPERIMENTAL | Newly diagnosed GBM patients who have completed chemoradiation treatment with temozolomide and received no subsequent maintenance temozolomide |
| Name | Type | Description |
|---|---|---|
| VAL-083 (Dianhydrogalactitol) | DRUG | VAL-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 | DRUG | The 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. |
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...
VAL-083 is an investigational small molecule being studied for the treatment of glioma, including glioblastoma and glioblastoma multiforme. It is being developed by TuHURA Biosciences, Inc. (NASDAQ: HURA) and is currently in Phase 2 clinical development for this indication.
VAL-083 is a small molecule that has been studied in patients with MGMT unmethylated glioblastoma. It is being evaluated in this biomarker-selected patient population, where the MGMT promoter methylation status is used to identify patients who may be eligible for treatment with VAL-083.
VAL-083 is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol HURA. The company is conducting clinical trials of VAL-083 in patients with glioma, including glioblastoma.
VAL-083 is in Phase 2 clinical development for glioma. It has completed three clinical trials, including two Phase 2 studies and one Phase 1 study. VAL-083 is an investigational drug and has not been approved by regulatory authorities.
VAL-083 has been studied in three completed clinical trials. These include NCT01478178, a Phase 1 safety study in patients with recurrent malignant glioma; NCT02717962, a Phase 2 study in patients with MGMT unmethylated, bevacizumab-naive glioblastoma; and NCT03050736, a Phase 2 study of VAL-083 combined with radiotherapy in newly diagnosed glioblastoma patients with unmethylated MGMT expression.
VAL-083 is the drug name used in clinical trials for this investigational small molecule. No alternative names for VAL-083 have been reported in the clinical trial information available.