Safusidenib in IDH1-mutant glioma after vorasidenib progression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional study enrolling up to 40 participants with Grade 2 or Grade 3 IDH1-mutant gliomas (including astrocytoma and 1p/19q co-deleted oligodendroglioma) who previously received vorasidenib and showed radiographic progression. Eligible participants have measurable disease confirmed by blinded central review and are not in urgent need of chemotherapy or radiotherapy. Safusidenib is the investigational intervention, with enrollment limited to sites at UCLA, UCSF, and Yale. Key endpoints will assess safety and any signs of clinical activity in a population that has limited remaining standard options.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

* Histologically confirmed Grade 2 or 3 IDH-mutant astrocytoma or IDH-mutant and 1p19q co-deleted oligodendroglioma, according to WHO CNS 2021 criteria
* IDH1 mutation (e.g., R132H/C/G/S/L) based on immunohistochemistry (IHC) (R132H only), PCR, or next generation sequencing (NGS).
* Have had at least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection).
* Measurable disease per modified RANO 2.0 confirmed by BICR during Screening.
* Previously treated with vorasidenib and experienced radiographic disease progression during treatment and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator. Disease progression must be confirmed by BICR using modified RANO 2.0.
* Adequate hematologic and organ function
* Expected survival of ≥12 months

Key Exclusion Criteria:

* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) and vorasidenib for treatment of glioma.
* Discontinued vorasidenib for toxicity or any reason other than radiographic disease progression
* Prior treatment with anti-angiogenic agents such as Avastin (bevacizumab) or investigational agents for glioma.
* Brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.
* Significant functional or neurocognitive deficits, including uncontrolled seizures
* Evidence of leptomeningeal disease.
* Use of therapeutic doses of steroids for signs/symptoms of glioma. Participants taking physiologic doses (defined as equivalent of \<1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.

Where it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting
• University of California, Los Angeles
  Los Angeles, California, United States Not yet recruiting
• University of California, San Francisco
  San Francisco, California, United States Not yet recruiting
• Yale University
  New Haven, Connecticut, United States Not yet recruiting
• University of Miami Health
  Miami, Florida, United States Not yet recruiting

Study contacts

• Study coordinator: Clinical Trials at Nuvation Bio
• Email: ClinicalTrials@nuvationbio.com
• Phone: 332-208-6102

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Safusidenib as maintenance therapy for IDH1‑mutant astrocytoma and oligodendroglioma

  This trial tests whether the oral drug safusidenib can help people with IDH1‑mutant astrocytomas or oligodendrogliomas remain progression‑free longer after surgery and standard radiation/chemotherapy.

  Recruiting at 59 sites Phase 3 Nuvation Bio Inc. · Birmingham, Alabama and 60 other locations · NCT05303519

• Combining All-Trans Retinoic Acid and PD-1 Inhibition for Recurrent IDH-Mutant Glioma

  This study is testing if a combination of a vitamin A derivative and a cancer immunotherapy can help people with recurrent IDH-mutant glioma feel better and fight their tumors.

  Recruiting Phase 2 Abramson Cancer Center at Penn Medicine · Philadelphia, Pennsylvania · NCT05345002

• YN003 injection in glioma patients

  This phase 1 study tests whether YN003 injected IV is safe and tolerable for adults with recurrent or progressive glioma, and to explore how the drug behaves in the body and any early signs of activity.

  Recruiting at 2 sites Phase 1 Beijing Inno Medicine Co., Ltd. · Los Angeles, California and 4 other locations · NCT07929909

• Brain connectome project in adults with brain glioma undergoing surgery

  This registry collects MRI data and clinical information from adults with glioma to see how brain networks relate to surgery and recovery.

  Recruiting Northwell Health · New York, New York · NCT07927595

• Proton vs. Photon Radiation for Certain Grade 2–3 Gliomas

  This study tests whether proton therapy can better preserve thinking and memory than photon therapy for adults with IDH-mutated grade 2–3 gliomas who need radiation.

  Recruiting at 2 sites University Hospital, Essen · Essen and 1 other locations · NCT07750457

• Connectome-guided network planning for brain tumor surgery in eloquent areas

  This study tests whether using patient-specific brain network maps from diffusion MRI can help surgeons plan and guide brain tumor removal in eloquent areas.

  Recruiting ARNAS Civico Di Cristina Benfratelli Hospital · Palermo, PA · NCT07717827

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.