OncoMatch/Clinical Trials/NCT06838676
ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas
Is NCT06838676 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies ACT001 for diffuse intrinsic pontine gliomas (dipg).
Treatment: ACT001 — This is a Phase II open-label study to investigate the safety and efficacy of ACT001 in patients with DIPG and H3K27-altered HGG.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Diffuse Intrinsic Pontine Glioma
Biomarker criteria
Required: H3-3A k27m
H3K27-altered DIPG or H3K27-altered HGG
Demographics
Prior therapy
Cannot have received: ACT001 (ACT001)
Patients who have previously received either ACT001 or parthenolide are not eligible.
Cannot have received: parthenolide (parthenolide)
Patients who have previously received either ACT001 or parthenolide are not eligible.
Lab requirements
Blood counts
Peripheral ANC > 1000/mm³; Platelet count > 100,000/mm³ (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² or age/gender-based serum creatinine
Liver function
total bilirubin must be ≤1.5X institutional ULN for age; AST/ALT ≤ 2.5 × institutional upper limit of normal; Serum albumin ≥ 2 g/dL
Cardiac function
Ejection fraction of ≥ 50% by echocardiogram; QTc ≤ 450 msec (by Bazett formula)
Adequate bone marrow, renal, liver, and cardiac function as defined in eligibility
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's Hospital Colorado · Aurora, Colorado
- Children's National Medical Center · Washington D.C., District of Columbia
- Nicklaus Children's Hospital · Miami, Florida
- Emory University/Children's Healthcare of Atlanta · Atlanta, Georgia
- C.S. Mott Children's Hospital · Ann Arbor, Michigan
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06838676 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior ACT001, parthenolide disqualifies patients from enrollment.
Does this trial require H3-3A?
Yes, H3-3A k27m is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 39 years or younger and at least 1 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify