OncoMatch/Clinical Trials/NCT05303519
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Is NCT05303519 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies safusidenib for glioma.
Treatment: safusidenib — This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma. The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled. The purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 R132H
IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing
Required: IDH1 R132C
IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing
Required: IDH1 R132H
IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS)
Required: IDH1 R132C
IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS)
Required: IDH1 R132G
IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS)
Required: IDH1 R132S
IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS)
Required: IDH1 R132L
IDH1 mutation (R132H/C/G/S/L) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS)
Required: CDKN2A status required
CDKN2A/B status and at least 1 of the following must be confirmed
Required: CDKN2B status required
CDKN2A/B status and at least 1 of the following must be confirmed
Required: ATRX loss of function mutation
presence of an ATRX loss of function mutation by NGS
Required: ATRX loss of normal expression
loss of normal ATRX expression by IHC
Required: 1P19Q absence of co-deletion
absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS
Required: 1P19Q co-deletion
The presence of 1p19q co-deletion must also be confirmed
Disease stage
Required: Stage GRADE 2, GRADE 3, GRADE 4 (WHO 2021)
WHO Grade 2 glioma or Grade 3 glioma...; Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification; Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria
Performance status
WHO 0–1
Prior therapy
Cannot have received: IDH1-targeted therapy
Patient did receive the prior therapy targeted to IDH1 mutation
Cannot have received: anti-angiogenic agents (bevacizumab)
prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab)
Cannot have received: IDH1 or IDH2-targeted therapy
agents known to target IDH1 or IDH2
Cannot have received: investigational agents for glioma
investigational agents for glioma
Lab requirements
Blood counts
Kidney function
Liver function
Has adequate hematologic and organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama · Birmingham, Alabama
- Mayo Clinic - Arizona · Phoenix, Arizona
- St. Joseph's Hospital and Medical Center · Phoenix, Arizona
- University of California, Los Angeles · Los Angeles, California
- Hoag Memorial Hospital Presbyterian · Newport Beach, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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