Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnose… (NCT06894979) | Clinical Trial Compass
RecruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, AZD1390, During Radiation Therapy for Newly Diagnosed High Grade Glioma, Diffuse Midline Glioma, or Diffuse Intrinsic Pontine Glioma
United States54 participantsStarted 2025-06-18
Plain-language summary
This phase I clinical trial studies the side effects and best dose of AZD1390 and to see how well it works when given together with radiation therapy for the treatment of pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma. AZD1390 is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving AZD1390 with radiation may be safe, tolerable, and/or effective in treating pediatric patients with high grade glioma, diffuse midline glioma or diffuse intrinsic pontine glioma.
Who can participate
Age range12 Months – 22 Years
SexALL
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Inclusion Criteria:
* COHORT A and COHORT B: For the dose escalation phase, patients must be ≥ 12 months and \< 18 years of age at the time of study enrollment
* COHORT C and COHORT D: For the disease expansion phase, patients must be ≥ 12 months and \< 22 years of age at the time of study enrollment
* Patients with newly diagnosed primary high-grade glioma (HGG), diffuse midline glioma (DMG) (excluding primary spinal tumors), or diffuse intrinsic pontine glioma (DIPG) who are eligible to receive 54-59.4 grey (Gy) fractionated radiation at 1.8 Gy/day. Patients must have had histologic verification of malignancy at original diagnosis except in patients with DIPG as defined below.
* COHORTS A AND C (SUPRATENTORIAL TUMORS):
* HGG and non-pontine DMG:
* Patients with newly diagnosed HGG (including diffuse hemispheric glioma, H3 G34-mutant; diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype; astrocytoma; IDH-mutant; or glioblastoma, IDH-wildtype): or non-pontine DMG (including diffuse midline glioma, H3 K27-altered; diffuse pediatric-type high-grade glioma, H3-wildtype and IDH-wildtype; astrocytoma; IDH-mutant; or glioblastoma, IDH-wildtype) require histologic diagnosis.
* COHORT B AND D (INFRATENTORIAL TUMORS):
* DIPG/pontine DMG or infratentorial HGG or DMG:
* Patients with newly diagnosed typical DIPG, defined as tumors with a pontine epicenter and diffuse involvement of at least 2/3 of the pons on at least 1 axial T2-weighted i…
What they're measuring
1
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ATM Kinase Inhibitor AZD1390 (AZD1390) for pediatric supratentorial high-grade gliomas
Timeframe: Up to 75 days
2
Maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AZD1390 for pediatric infratentorial high-grade gliomas
Timeframe: Up to 75 days
3
Incidence of adverse events for AZD1390 for pediatric supratentorial high-grade gliomas
Timeframe: Up to 5 years
4
Incidence of adverse events for AZD1390 for pediatric infratentorial high-grade gliomas