Actively Recruiting
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Led by Nuvation Bio Inc. · Updated on 2026-03-05
365
Participants Needed
45
Research Sites
390 weeks
Total Duration
On this page
Sponsors
N
Nuvation Bio Inc.
Lead Sponsor
A
AnHeart Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at consent
- Histologically confirmed recurrent or progressive WHO Grade 2 or Grade 3 glioma with IDH1 mutation for Part 1
- No more than 2 prior therapies for disease recurrence or progression
- Measurable lesion(s) as per RANO criteria
- Diagnosis of IDH1-mutant Grade 2, Grade 3 with high-risk features, or Grade 4 astrocytoma for Part 2
- Completion of radiation therapy and 6 to 12 cycles of adjuvant temozolomide for Part 2
- Histologically confirmed Grade 3 IDH-mutant oligodendroglioma for Part 3
- At least 90 days and no more than 5 years since most recent surgery for glioma for Part 3
- Residual or recurrent measurable disease for Part 3
- Adequate hematologic and organ function
- Agreement to submit sufficient tumor tissue for biomarker and histological analyses (may be waived)
You will not qualify if you...
- Recent anti-cancer therapy before study treatment start (systemic drugs within 3 weeks, lomustine within 6 weeks, surgery within 3 weeks, radiation within 12 weeks)
- Known hypersensitivity to safusidenib or similar drugs
- Prior or anticipated treatment with anti-angiogenic agents, IDH1/IDH2 targeting agents, or investigational agents for glioma
- Brainstem or spinal cord involvement by tumor
- Significant functional or neurocognitive deficits including uncontrolled seizures
- Evidence of diffuse leptomeningeal disease
- Significant cardiac disease within 12 months prior to randomization or first dose
- Unstable corticosteroid dosing in the 14 days prior to randomization or first dose
- Other malignancies unless disease-free for at least 3 years
- Conditions interfering with study participation
- Prior anticancer therapies beyond specified for each study part (e.g., only surgery allowed before Part 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
University of Alabama
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Mayo Clinic - Arizona
Phoenix, Arizona, United States, 85013
Actively Recruiting
3
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
Actively Recruiting
4
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
5
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States, 92663
Actively Recruiting
6
Stanford University
Palo Alto, California, United States, 94304
Actively Recruiting
7
University of California
San Francisco, California, United States, 94143
Actively Recruiting
8
University of Colorado Health Cancer Care
Aurora, Colorado, United States, 80045
Not Yet Recruiting
9
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
10
University of Florida Health
Gainesville, Florida, United States, 32608
Actively Recruiting
11
Mayo Clinic - Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
12
University of Miami Health
Miami, Florida, United States, 33136
Actively Recruiting
13
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Actively Recruiting
14
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
15
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Actively Recruiting
16
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
17
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
18
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
19
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
20
Rutgers Cancer Institute
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
21
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
22
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
23
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
24
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
25
Cleveland Clinic
Cleveland, Ohio, United States, 44106
Actively Recruiting
26
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
27
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
28
Huntsman Cancer Insititute, University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
29
UVA Health, Emily Couric Clinical Cancer Cente
Charlottesville, Virginia, United States, 22903
Actively Recruiting
30
Fred Hutch Cancer Center
Seattle, Washington, United States, 98195
Actively Recruiting
31
University of Wisconsin Health
Madison, Wisconsin, United States, 53792
Actively Recruiting
32
St Vincents Hospital Sydney (Kinghorn)
Darlinghurst, New South Wales, Australia
Actively Recruiting
33
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Not Yet Recruiting
34
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Actively Recruiting
35
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Actively Recruiting
36
The Alfred
Melbourne, Victoria, Australia
Actively Recruiting
37
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
38
Sanbo Brain Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100093
Actively Recruiting
39
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 10053
Actively Recruiting
40
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Not Yet Recruiting
41
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
42
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
43
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
44
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
45
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
C
Clinical Trials at Nuvation Bio
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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