SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)

Active:	Yes
Cancer Type:	Brain & Spinal Cord Tumor Brain Tumor Unknown Primary	NCT ID:	NCT05303519
Trial Phases:	Phase III	Protocol IDs:	AB-218-G203 (primary) NCI-2023-02081
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Nuvation Bio Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05303519

Summary

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.

Objectives

Part 1 of this study will enroll up to 25 patients that will be randomized 1:1:1:1:1 (5
patients per group) to receive one of the daily oral doses of safusidenib at 125 mg twice
a day (BID), 250 mg BID, 500 mg once daily (QD), 375 mg BID, or 500 mg BID. The PK
characteristics and safety and initial efficacy data will be assessed in Part 1.

Part 1 was fully enrolled as of 19 Dec 2023 and participants are currently ongoing.

Part 2 will include approximately 300 participants with 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. Participants will
be randomized (1:1) after their last dose of adjuvant temozolomide to receive either oral
safusidenib 250 mg BID or placebo in 28-day continuous cycles. Patients will continue
treatment until progression of disease or until other discontinuation criteria are met.
The tumor response evaluation will be conducted on a regular basis until progression of
disease per Blinded Independent Central Review (BICR), consent withdrawal, or death,
whichever occurs first. Long-term survival follow-up will be conducted as well.

Part 3 will include approximately 40 participants with residual or recurrent IDH1-mutant
Grade 3 oligodendroglioma with measurable disease who have undergone surgery as their
only treatment and are not in need of immediate chemotherapy or radiotherapy.
Participants will receive oral safusidenib 250 mg BID in 28-day continuous cycles until
disease progression or another reason for discontinuation occurs.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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