SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

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NCT05303519 · readout in 835 d

Sponsored by Nuvation Bio Inc. (industry) · NUVB — their whole pipeline →. With AnHeart Therapeutics Inc..

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

365estimated

Sites

Countries

Australia, China, United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2023-06-05

actual

When the study began enrolling

Primary completion

2028-12-01

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2030-12-01

estimated

The whole study's end, after follow-up

First posted

2022-03-31

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-01

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Glioma
Astrocytoma, Grade IV
IDH1-mutant Glioma
Astrocytoma, IDH-Mutant, Grade 3
Astrocytoma, IDH-Mutant, Grade 4
Astrocytoma, IDH-Mutant, Grade 2
Oligodendroglioma
Oligodendroglioma, IDH-Mutant and 1p/19q-Codeleted

Interventions

Drug: safusidenib — also filed as DS-1001b, AB-218
Drug: Placebo

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Incidence of adverse events (AEs) and serious adverse events (SAEs)

measured From participants sign ICF to 30 days after last dose，average 2 years

Part 2: Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0

measured From randomization until the date of first documented disease progression, average 2 years

Part 3 Objective Response Rate (ORR) (Complete Response (CR), Partial Response (PR) and Minor Response (MR)) assessed by Blinded Independent Central Review (BICR) per Response Assessment in Neuro-Oncology (RANO) 2.0

measured From the first dose of study drug until the date of first documented disease progression, average 18 months

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