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ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas

NCT06838676 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-15

No results posted yet for this study

Summary

This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.

Conditions

  • Diffuse Intrinsic Pontine Gliomas (DIPG)
  • Progressive DIPG
  • Refractory DIPG
  • Recurrent DIPG
  • H3K27-altered High Grade Glioma

Interventions

DRUG

ACT001

PO BID at 875 mg/m2 for 28 days

Sponsors & Collaborators

  • Accendatech USA Inc.

    collaborator INDUSTRY

  • Nationwide Children's Hospital

    lead OTHER

Principal Investigators

  • David S. Ziegler, MD, FRACP · Sydney Children's Hospitals Network

  • Sara Khan, MD, PhD, FRACP · Nationwide Children's Hospital

  • Peter de Blank, MD, MSCE · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2028-07-31
Completion
2035-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06838676 on ClinicalTrials.gov