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 (May 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
Cancer type
Diffuse Intrinsic Pontine Glioma
Glioblastoma
Biomarker criteria
Required: H3C2 K27 alteration
H3K27-altered HGG
Prior therapy
Must have received: radiation therapy — frontline
have completed radiation therapy (RT) within 28 to 35 calendar day prior to start of therapy [Cohort A]; following frontline treatment that included at least focal RT [Cohort B]
Cannot have received: anti-cancer therapy other than surgery, radiation, and/or steroids
Patients must not have received any prior therapy other than surgery, radiation (focal to disease) and/or steroids [Cohort A]
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
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
Peripheral ANC > 1000/mm³; Platelet count > 100,000/mm³ (transfusion independent)
Kidney function
Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m² or age/gender-based serum creatinine
Liver function
total bilirubin within normal institutional limits; AST/ALT ≤ 2.5 × institutional upper limit of normal; Serum albumin ≥ 2 g/dL
Cardiac function
Ejection fraction of ≥ 50% by echocardiogram; QTc ≤ 480 msec (by Bazett formula)
Adequate bone marrow, renal, liver, and cardiac function as defined in inclusion criterion 6
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 →
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