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Safety and Efficacy Study of Safusidenib in Participants With IDH1-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

27. august 2026 oppdatert av: Nuvation Bio Inc.

A Phase 2, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma Who Discontinued Vorasidenib Treatment Due to Progressive Disease

This study will include up to 40 participants with Grade 2 or Grade 3 IDH1-mutant glioma who have undergone surgery and received vorasidenib as their only treatment, experienced radiographic disease progression on vorasidenib (confirmed by Blinded Independent Central Review [BICR] per modified Response Assessment in Neuro-Oncology [RANO] 2.0), and are not in need of immediate chemotherapy or radiotherapy.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90095
        • University of California, Los Angeles
        • Hovedetterforsker:
          • Robert Chong, MD
        • Ta kontakt med:
      • San Francisco, California, Forente stater, 94143
        • University of California, San Francisco
        • Hovedetterforsker:
          • John De Groot, MD
        • Ta kontakt med:
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06510
    • Indiana
      • Indianapolis, Indiana, Forente stater, 46202
        • Indiana University
        • Hovedetterforsker:
          • Kathryn Nevel, MD
        • Ta kontakt med:
          • NeuroOncology Clinical Trials
          • Telefonnummer: 3179634823
          • E-post: neuroct@iu.edu
    • New Jersey
      • New Brunswick, New Jersey, Forente stater, 08901
        • Rutgers Cancer Institute
        • Hovedetterforsker:
          • Morana Vojnic, MD
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10032
        • Columbia University Medical Center
        • Hovedetterforsker:
          • Andrew Lassman, MD
        • Ta kontakt med:
      • New York, New York, Forente stater, 10016

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Safusidenib
Safusidenib 250 mg BID
Legemiddel: Safusidenib
Safusidenib administered twice daily as a single agent orally on Days 1 to 28 of a 28-day cycle. Participants may continue treatment until disease progression or another reason for discontinuation occurs.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
Tidsramme: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
ORR defined as the proportion of participants with the confirmed best overall response of Complete Response (CR), Partial Response (PR) or Minor Response (MR) per modified RANO 2.0, assessed by BICR
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ORR per modified RANO 2.0 assessed by Investigator
Tidsramme: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
ORR defined as the proportion of participants with the confirmed best overall response of CR, PR or MR per modified RANO 2.0, assessed by the Investigator
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Volumetric Tumor Growth Rate (TGR) by BICR
Tidsramme: From historical scans through the final scan in the study, approximately 18 months
TGR defined as the percentage change in tumor volume by unit of time, assessed by BICR
From historical scans through the final scan in the study, approximately 18 months
Duration of Response (DOR) per modified RANO 2.0 assessed by BICR and by Investigator
Tidsramme: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
DOR, time from the first documentation of objective response (CR, PR, or MR) to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Time to Next Intervention (TTNI)
Tidsramme: From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months
TTNI, defined as the time from the first dose of study drug to the initiation of first subsequent anticancer therapy or death from any cause, whichever occurs earlier
From the date of first dose of study drug until the date of the start of another anticancer treatment or date of death, approximately 18 months
Progression Free Survival (PFS) per modified RANO 2.0 assessed by BICR and by Investigator
Tidsramme: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
PFS, defined as the time from the first dose of study drug to the date of the first occurrence of radiographic disease progression per modified RANO 2.0 assessed by BICR and by the Investigator or death from any cause, whichever occurs earlier.
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Time to Response (TTR) per modified RANO 2.0 assessed by BICR and by Investigator
Tidsramme: From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months
TTR, defined as the time from the first dose of study drug to the first documentation of objective response (CR, PR, or MR) per modified RANO 2.0, assessed by BICR and by the Investigator
From the date of first dose of study drug to the first documentation of objective response (CR, PR, or MR), approximately 18 months
Overall Survival (OS)
Tidsramme: From the date of first dose of study drug until the date of death, approximately 18 months
OS, defined as the time from the first dose of study drug to death from any cause.
From the date of first dose of study drug until the date of death, approximately 18 months
Safety and tolerability
Tidsramme: From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months
The safety and tolerability of safusidenib evaluated based on AEs graded by NCI-CTCAE version 5.0, laboratory abnormalities as graded by NCI-CTCAE version 5.0, vital signs, physical examinations, and ECGs
From the date of first dose of study drug until 30 days after the date of the last dose of study drug, approximately 18 months
Seizure Activity
Tidsramme: From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months
Evaluate seizure frequencies and severity including type of seizure, seizure-related AEs, and changes in anti-epileptic medications in participants receiving safusidenib
From the date of first dose of study drug until the date of first documented disease progression, approximately 18 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Nuvation Bio Inc.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. september 2030

Studiet fullført (Antatt)

1. mars 2032

Datoer for studieregistrering

Først innsendt

9. juli 2026

Først innsendt som oppfylte QC-kriteriene

9. juli 2026

Først lagt ut (Faktiske)

14. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

27. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NUV-218-G209

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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