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Part A: Safusidenib Erbumine

Phase 1

Glioma | Small molecule | Oncology |Nuvation Bio Inc.|Last Updated: Mar 18, 2026

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05577416A Study of AB-218 in Patients With IDH1 Mutated Low Grade GliomaEARLY_PHASE1 COMPLETED 14 — — Oct 11, 2022Mar 26, 2025Mar 18, 20261 Australia
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Study Endpoints
Primary Endpoints
Phase 0: Feasibility of Phase 0 study in patient population
14 months

Number of patients to complete all planned investigations and procedures

Phase 0: pharmacokinetic analysis of tumour tissue
4 weeks

Total and unbound AB-218 in tumour tissue

Phase 0: pharmacokinetic analysis of cerebrospinal fluid (CSF)
4 weeks

Total and unbound AB-218 in CSF

Phase 2: Number of Adverse events
up to 30 days after last study dose

Number of adverse events (AEs) according to NCI CTCAE v 5

Phase 2: Incidence of drug related adverse events
up to 30 days after last study dose

Drug related adverse events

Phase 2: Incidence of dose limiting toxicity
up to 30 days after last study dose

Dose limiting toxicity events

Secondary Endpoints
Phase 0: Incidence of treatment emergent Adverse events
during 1 cycle of AB-128, prior to maximal resection (4 weeks)
Phase 0: Safety of planned craniotomy and resection after stereotactic biopsy and treatment with AB-218
30 days after maximal resection
Phase 0: Pharmacodynamic (PD) analysis of AB-218 in tumour
after maximal resection (4 weeks), at progression (optional)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Safusidenib Erbumine (AB-218)EXPERIMENTALPart A: Peri-operative treatment (Phase 0); Part B: Post operative adjuvant therapy (phase 2)
Interventions
NameTypeDescription
BiopsyPROCEDUREPatients will undergo stereotactic biopsy by craniotomy or burr hole.
Part A: Safusidenib ErbumineDRUGPart A: Safusidenib Erbumine orally 250 mg BID for 28 days.
Surgery (maximal resection)PROCEDURESurgery: Maximal safe resection, within 24 hours of last dose of Safusidenib Erbumine.
Part B: Safusidenib ErbumineDRUGPart 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.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

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. ...

Countries:Australia
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