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Also known as VAL-083
VAL-083, Dianhydrogalactitol · 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 glioma, including glioblastoma and glioblastoma multiforme. Its clinical trials have enrolled adults with newly diagnosed or recurrent disease, with a focus on tumors that have unmethylated MGMT expression. It is in Phase 2 development and is not an approved therapy.
VAL-083 is being developed by TuHURA Biosciences, Inc., which trades under the ticker HURA. The company is the sponsor behind the Phase 2 and earlier clinical programs evaluating VAL-083 in glioma, including glioblastoma, in the United States and China.
VAL-083 is in Phase 2 clinical development for glioma. It is investigational and has not been approved by the FDA. Three completed studies support the program: two Phase 2 trials and one Phase 1/Phase 2 trial, together enrolling 202 patients.
Three completed trials have evaluated VAL-083 in glioma. NCT02717962 was a Phase 2 study in MGMT unmethylated, bevacizumab-naive glioblastoma in the adjuvant or recurrent setting, enrolling 118 patients in the United States. NCT03050736 tested VAL-083 with radiotherapy in newly diagnosed GBM in China, and NCT01478178 was a Phase 1/Phase 2 study in recurrent malignant glioma.
Yes, VAL-083 is dianhydrogalactitol. The two names refer to the same investigational small molecule, so searches for either term lead to the same glioma development program run by TuHURA Biosciences under the ticker HURA.
Yes, the VAL-083 glioma program is biomarker selected. The Phase 2 trials enrolled patients whose tumors had unmethylated MGMT expression, including NCT02717962 in bevacizumab-naive glioblastoma and NCT03050736 in newly diagnosed GBM receiving radiotherapy. All three completed studies enrolled adults aged 18 years and older.