Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

27 août 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • California
      • Los Angeles, California, États-Unis, 90095
        • University of California, Los Angeles
        • Chercheur principal:
          • Robert Chong, MD
        • Contact:
      • San Francisco, California, États-Unis, 94143
        • University of California, San Francisco
        • Chercheur principal:
          • John De Groot, MD
        • Contact:
    • Connecticut
    • Indiana
      • Indianapolis, Indiana, États-Unis, 46202
        • Indiana University
        • Chercheur principal:
          • Kathryn Nevel, MD
        • Contact:
          • NeuroOncology Clinical Trials
          • Numéro de téléphone: 3179634823
          • E-mail: neuroct@iu.edu
    • New Jersey
      • New Brunswick, New Jersey, États-Unis, 08901
        • Rutgers Cancer Institute
        • Chercheur principal:
          • Morana Vojnic, MD
        • Contact:
    • New York
      • New York, New York, États-Unis, 10032
        • Columbia University Medical Center
        • Chercheur principal:
          • Andrew Lassman, MD
        • Contact:
      • New York, New York, États-Unis, 10016

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Safusidenib
Safusidenib 250 mg BID
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
ORR per modified RANO 2.0 assessed by Investigator
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nuvation Bio Inc.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 mars 2027

Achèvement primaire (Estimé)

1 septembre 2030

Achèvement de l'étude (Estimé)

1 mars 2032

Dates d'inscription aux études

Première soumission

9 juillet 2026

Première soumission répondant aux critères de contrôle qualité

9 juillet 2026

Première publication (Réel)

14 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • NUV-218-G209

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner