Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Safusidenib Erbumine · 1 trial · 1 indication
Number of patients to complete all planned investigations and procedures
Total and unbound AB-218 in tumour tissue
Total and unbound AB-218 in CSF
Number of adverse events (AEs) according to NCI CTCAE v 5
Drug related adverse events
Dose limiting toxicity events
| Arm | Type | Description |
|---|---|---|
| Safusidenib Erbumine (AB-218) | EXPERIMENTAL | Part A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2) |
| Name | Type | Description |
|---|---|---|
| Biopsy | PROCEDURE | Patients will undergo stereotactic biopsy by craniotomy or burr hole. |
| Part A: Safusidenib Erbumine | DRUG | Part A: Safusidenib Erbumine orally 250 mg BID for 28 days. |
| Surgery (maximal resection) | PROCEDURE | Surgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine. |
| Part B: Safusidenib Erbumine | DRUG | Part B: Safusidenib Erbumine orally 250 mg BID for 28 days for a minimum of 12, 28-day cycles subject to ongoing documented evidence of clinical benefit, until disease progression or unacceptable toxicity. |
Inclusion Criteria: 1. Histologically confirmed LGG or new diagnosis of LGG based on MRI 2. Tumours suitable for biopsy and safe for maximal resection in the opinion of the treating neurosurgeon 3. Patients who in the consensus of the treating neurosurgeon require resection of the brain tumour. 4. ...
Safusidenib Erbumine is an investigational small molecule developed by Nuvation Bio Inc. (ticker NUVB) for glioma, a type of brain tumor. It is being studied in patients with IDH1 mutated low grade glioma and has received a FAST_TRACK designation from the FDA. It remains in clinical development.
Safusidenib Erbumine is being developed for the treatment of glioma, specifically IDH1 mutated low grade glioma. The clinical program enrolls adults 18 years and older with this biomarker-selected tumor type. It is investigational and has not been established as a marketed therapy.
Safusidenib Erbumine targets IDH1, an isocitrate dehydrogenase enzyme, and acts as an inhibitor of that target. Because the program selects patients whose gliomas carry IDH1 mutations, the drug is directed at the mutated form of the enzyme in this tumor setting.
Safusidenib Erbumine is developed by Nuvation Bio Inc., which trades under the ticker NUVB. Nuvation Bio is the sponsor of the clinical program evaluating the drug in IDH1 mutated low grade glioma.
Safusidenib Erbumine is in Phase 1 development. Its single recorded trial, NCT05577416, is listed as early Phase 1 and has completed. The drug is investigational and is not described as FDA approved; it holds a FAST_TRACK designation for its development program.
Safusidenib Erbumine has been studied in NCT05577416, titled A Study of AB-218 in Patients With IDH1 Mutated Low Grade Glioma. That early Phase 1 trial enrolled 14 patients in Australia, was uncontrolled and not randomized, and is now completed.
Yes. Safusidenib Erbumine is also known as AB-218, the name used in its clinical trial NCT05577416, which studied AB-218 in patients with IDH1 mutated low grade glioma. Searches for either name refer to the same investigational IDH1 inhibitor from Nuvation Bio.