Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VAL-083 (Dianhydrogalactitol)
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 other malignant brain cancers. It has been evaluated in patients with newly diagnosed and recurrent disease, with a focus on tumors that have unmethylated MGMT expression, a biomarker used to select patients for treatment.
VAL-083 is being developed by TuHURA Biosciences, Inc., which trades under the ticker HURA. The company is the sponsor of the clinical program evaluating the drug in glioma, including glioblastoma and related malignant brain cancers.
VAL-083 is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. Three completed trials have studied the drug in glioma, including one Phase 1 study and two Phase 2 studies, with a combined enrollment of 202 patients.
Three completed trials have evaluated VAL-083 in glioma. NCT03050736 tested VAL-083 with radiotherapy in newly diagnosed glioblastoma with unmethylated MGMT expression in China. NCT02717962 studied the drug in MGMT unmethylated, bevacizumab-naive glioblastoma in the United States. NCT01478178 was a Phase 1 study in recurrent malignant glioma.
Yes. VAL-083 is also known as dianhydrogalactitol. These names refer to the same small molecule, so searches for either term point to the same investigational glioma program being developed by TuHURA Biosciences.
Across the three completed clinical trials of VAL-083 in glioma, 202 patients have been enrolled in total. The largest study, NCT02717962, enrolled 118 patients in the United States, while NCT01478178 enrolled 55 and NCT03050736 enrolled 29.