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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 de agosto de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

40

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Los Angeles, California, Estados Unidos, 90095
        • University of California, Los Angeles
        • Investigador principal:
          • Robert Chong, MD
        • Contacto:
      • San Francisco, California, Estados Unidos, 94143
        • University of California, San Francisco
        • Investigador principal:
          • John De Groot, MD
        • Contacto:
    • Connecticut
      • New Haven, Connecticut, Estados Unidos, 06510
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University
        • Investigador principal:
          • Kathryn Nevel, MD
        • Contacto:
          • NeuroOncology Clinical Trials
          • Número de teléfono: 3179634823
          • Correo electrónico: neuroct@iu.edu
    • New Jersey
      • New Brunswick, New Jersey, Estados Unidos, 08901
        • Rutgers Cancer Institute
        • Investigador principal:
          • Morana Vojnic, MD
        • Contacto:
    • New York
      • New York, New York, Estados Unidos, 10032
        • Columbia University Medical Center
        • Investigador principal:
          • Andrew Lassman, MD
        • Contacto:
      • New York, New York, Estados Unidos, 10016

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Safusidenib
Safusidenib 250 mg BID
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response Rate (ORR) per modified Response Assessment in Neuro-Oncology (RANO) 2.0 assessed by Blinded Independent Central Review (BICR)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ORR per modified RANO 2.0 assessed by Investigator
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Nuvation Bio Inc.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de marzo de 2027

Finalización primaria (Estimado)

1 de septiembre de 2030

Finalización del estudio (Estimado)

1 de marzo de 2032

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

28 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • NUV-218-G209

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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