Concurrent XRD-0394 With Radiation Therapy for High Grade Gliomas

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT06829173
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • High-Grade Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • XRD-0394 — DRUG
    Administered orally; small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and DNA-PK.
  • Radiation Therapy — RADIATION
    For Cohort A and Cohort B, the neoadjuvant "boost" radiation dose is 1400cGy delivered over 7 fractions, and the adjuvant radiation dose is 5000cGy delivered over 25 fractions for a total dose of 6400cGy over 32 fractions, accounting for the treatment break between boost and adjuvant RT. For Cohort C, the radiation dose is 3500cGy delivered over 10 fractions.
  • Surgical Resection — PROCEDURE
    Resection of tumor tissue.

Study Details

This is an open-label, dose-finding study of XRD-0394 in subjects with newly diagnosed and recurrent high grade gliomas receiving radiation therapy, with and without concurrent temozolomide based on O6-Methylguanine-DNA methyltransferase (MGMT) status for patients with newly diagnosed high grade gliomas.

Key Dates

Start date
Nov 5, 2025
Status verified
Dec 2025
Primary completion
May 31, 2027
Completion
May 31, 2031

Study Design

Enrollment
39 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-Surgery Dose-Escalation
    Patients with newly-diagnosed high grade gliomas (HGG) receiving neoadjuvant radiation therapy (RT) prior to surgical resection will be enrolled in the Pre-Surgical Dose-Escalation arm, at one of two dose levels: Participants enrolled at Pre-Surgical Dose Level 1 (DL1) will receive 160mg daily XRD-0394 on the days of radiation therapy before surgery. Participants enrolled at Pre-Surgery Dose Level 2 (DL2) will receive 300mg daily XRD-0394 on the days of radiation therapy before surgery. All patients enrolled in the pre-surgical dose escalation portion of the study will receive DL1 in the post-surgical dose-escalation portion of the study, but will not be enrolled in the Post-Surgery Dose Escalation arms for purpose of analysis.
  • Experimental: Cohort A: Post-Surgery Dose Escalation
    MGMT-methylated patients will be enrolled in Cohort A following surgical resection. Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 3 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.
  • Experimental: Cohort B: Post-Surgery Dose Escalation
    MGMT-unmethylated patients will be enrolled in Cohort B following surgical resection. Participants enrolled at Post-Surgery Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Post-Surgery Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.
  • Experimental: Cohort C: Dose-Escalation (No Surgery)
    Patients with recurrent high-grade glioma (HGG) will be enrolled in Cohort C. Participants enrolled at Dose-Level 1 (DL1) will receive 160 mg XRD-0394 administered twice weekly, concurrently with radiation therapy. Participants enrolled at Dose-Level 2 (DL2) will receive 160 mg XRD-0394 administered three times weekly, concurrently with radiation therapy. Participants enrolled at Dose-Level 2 (DL3) will receive 300 mg XRD-0394 administered three times weekly, concurrently with radiation therapy.

Primary Outcome Measure

Number of Participants who Experience Dose-Limiting Toxicities (DLTs) [ Time Frame: End of DLT Monitoring Period (Pre-surgical dose-escalation: Day 8; Cohort C: Day 44; Cohorts A & B: Day 108) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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NYU Langone Health· New York, NY

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