Actively Recruiting
A Phase 3 Multicenter Clinical Study to Evaluate the Safety and Efficacy of Safusidenib Erbumine in Participants With IDH1-Mutant Glioma
Led by Nuvation Bio Inc. · Updated on 2026-03-05
365
Participants Needed
45
Research Sites
104 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
Researchers are studying safusidenib, a drug being tested in participants with certain types of IDH1-mutant gliomas, including Grade 2, Grade 3, and Grade 4 astrocytomas, as well as Grade 3 oligodendrogliomas. This study has three parts, each focusing on different patient groups and treatment goals. The trial aims to evaluate the drug's safety, how it behaves in the body, and its effect on tumor progression compared to placebo or no additional treatment after standard therapies. Part 1 involves up to 25 participants with recurrent or progressive Grade 2 or 3 gliomas receiving various doses of safusidenib orally twice or once daily to assess safety and drug levels. Part 2 includes about 300 participants with high-risk astrocytomas or Grade 4 astrocytomas who will be randomly assigned to receive either safusidenib or placebo after completing radiation and chemotherapy. Part 3 enrolls around 40 participants with residual or recurrent Grade 3 oligodendroglioma who have only had surgery and no other treatments; they will receive safusidenib continuously. Participants will take the study drug in 28-day cycles and continue until their disease progresses or they stop for other reasons. Regular tumor scans and evaluations will monitor response and progression. Researchers will assess progression-free survival, response rates, adverse events, and quality of life over periods averaging from 18 months up to 7 years. Safety and long-term survival follow-up will also be conducted throughout the study.
CONDITIONS
Brief Title
SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of consent.
- Have histologically confirmed IDH1-mutant Grade 2 or Grade 3 glioma or Grade 4 astrocytoma.
- Confirm IDH1 mutation using approved laboratory tests.
- Have received no more than two prior therapies for disease recurrence or progression.
- Have measurable disease as defined by neuro-oncology criteria.
- For Parts 2 and 3, provide sufficient tumor tissue for biomarker analysis.
- For Part 2, completed radiation and chemotherapy with temozolomide, meeting timing and treatment criteria.
- For Part 3, have had surgery only with no prior chemotherapy or radiotherapy, and residual or recurrent measurable disease.
You will not qualify if you...
- Received anti-cancer therapies within specified recent timeframes before starting study treatment.
- Prior therapy targeted to IDH1 mutation.
- Known allergy to safusidenib or similar drugs.
- Prior or planned use of anti-angiogenic agents, IDH1/IDH2-targeting agents, or investigational glioma treatments.
- Brainstem or spinal cord tumor involvement.
- Significant neurological or cognitive impairments preventing study participation.
- Evidence of diffuse leptomeningeal disease.
- Significant heart disease within the past year.
- Unstable corticosteroid use before study start.
- Other malignancies unless disease-free for at least three years.
- Conditions increasing risk or interfering with study participation.
- For Part 2, no anticancer treatments except specified standard therapies.
- For Part 3, no prior anticancer therapy other than surgery for glioma.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until disease progression or discontinuation
Participants receive daily oral doses of safusidenib or placebo in 28-day continuous cycles. Treatment continues until disease progression or other discontinuation criteria are met.
Regular visits for treatment and tumor response evaluation per cycle
Duration - Up to 7 years
Participants are monitored for long-term survival and safety after treatment ends.
Periodic visits for safety and survival assessments
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
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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