OncoMatch/Clinical Trials/NCT06838676
ACT001 for the Treatment of Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas
Official title: A Phase II Trial of ACT001 in Children and Adolescents With Diffuse Intrinsic Pontine Gliomas and H3K27-altered High Grade Gliomas
Is NCT06838676 recruiting? Yes, currently enrolling (Oct 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
Required: HIST1H3B k27m
H3K27-altered DIPG or H3K27-altered HGG
Demographics
Prior therapy
Must have received: radiation therapy — DIPG (Cohort A)
Patients must have completed radiation therapy (RT) within 28 to 35 calendar day prior to start of therapy
Cannot have received: anti-cancer therapy for DIPG (other than surgery, RT, concurrent temozolomide, or bevacizumab with washout)
No other prior anticancer therapy for DIPG will be allowed (Cohort A)
Cannot have received: ACT001
Patients who have previously received either ACT001 or parthenolide are not eligible
Cannot have received: parthenolide
Patients who have previously received either ACT001 or parthenolide are not eligible
Cannot have received: allogenic stem cell transplant
Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study
Cannot have received: solid organ transplant
Patients who received allogenic stem cell transplant or solid organ transplant are not eligible for study
Lab requirements
Blood counts
ANC > 1000/mm³; Platelet count > 100,000/mm³ (transfusion independent, 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 ≤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 anti-cancer therapy for DIPG (other than surgery, RT, concurrent temozolomide, or bevacizumab with washout), ACT001, parthenolide disqualifies patients from enrollment.
Does this trial require H3-3A?
Yes, H3-3A k27m is a required biomarker for enrollment.
Does this trial require HIST1H3B?
Yes, HIST1H3B 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