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NCT06072586 · ClinicalTrials.gov registry record · Early Phase 1
A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions
A Early Phase 1 study of Glioblastoma and High Grade Glioma, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 82
- Enrollment target
- 2
- Study locations
NCT06072586 is a Early Phase 1 study of Glioblastoma and High Grade Glioma that is actively recruiting participants, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 82 participants, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (24% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06072586, a Early Phase 1 study of Glioblastoma and High Grade Glioma, is actively recruiting participants, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 82 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma (HGG) and newly-diagnosed glioblastoma (nGBM). BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be given safely to people who have tumors that can be dependent on that growth signal because of changes in a protein called EGFR. These gene changes are called amplifications, mutations, fusions or alterations and are found only in the tumors. The study design includes a Phase 0 component with PK/PD-trigger for participant enrollment into an Expansion Phase 1 component. The primary objective of the Phase 0 component is to evaluate the PK endpoints of BDTX-1535. The primary objective of the Phase 1 component is to establish the safe dose of BDTX-1535 to be used in participants with a specified treatment regimen, three of which include standard of care radiotherapy for nGBM participants.
Conditions Studied
Interventions
- DRUG BDTX-1535
- DRUG BDTX-1535 combined with radiation therapy
- DRUG BDTX-1535 combined with temozolomide and radiation therapy
Study Locations (2)
Arizona
- Chandler Regional Medical Center - Chandler
- St. Joseph's Hospital and Medical Center - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2027-12 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06072586
The ClinicalTrials.gov registry entry for NCT06072586 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 108-participant average among 199 other Glioblastoma trials with a reported enrollment target (24% lower). The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which BDTX-1535 is the first listed.
NCT06072586 reports 2 study locations spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT06072586 about?
NCT06072586 is a clinical study titled "A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (rHGG) and Newly Diagnosed Glioblastoma (nGBM) Participants With EGFR Alterations or Fusions". This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma (HGG) and newly-diagnosed glioblastoma (nGBM). BDTX-1535 was designed to block a growth signal important to some cancers. BDTX-1535 is being tested in this study to see if it can be g...
What is the current status of trial NCT06072586?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 82 participants. The study started on 2023-10-18. Estimated completion is 2027-12.
What conditions does trial NCT06072586 study?
This clinical trial studies the following conditions: Glioblastoma, High Grade Glioma.
What interventions are being tested in trial NCT06072586?
The interventions under investigation include: BDTX-1535 (DRUG), BDTX-1535 combined with radiation therapy (DRUG), BDTX-1535 combined with temozolomide and radiation therapy (DRUG).
Who is sponsoring clinical trial NCT06072586?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06072586 being conducted?
This trial has 2 study locations across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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