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Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions

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ClinicalTrials.gov Identifier: NCT06072586
Recruitment Status : Recruiting
First Posted : October 10, 2023
Last Update Posted : November 28, 2023
Sponsor:
Collaborators:
Ivy Brain Tumor Center
Barrow Neurological Institute
Information provided by (Responsible Party):
St. Joseph's Hospital and Medical Center, Phoenix

Study Description
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Brief Summary:
This study will administer the investigational drug, BDTX-1535 to eligible patients with recurrent high-grade glioma. 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.

Condition or disease Intervention/treatment Phase
High Grade Glioma Drug: BDTX-1535 Early Phase 1

Detailed Description:
Eligible participants will enroll in the Phase 0 study and receive BDTX-1535 prior to a planned resection. During surgery, blood, tumor, and CSF samples will be collected to measure the amount of drug that is present in the samples. Participants with tumors demonstrating PK response will continue with once-daily BDTX-1535 treatment, continuously in 28-day cycles after surgery. Participants will continue to receive BDTX-1535 until the progression of disease, unacceptable toxicity or death, withdrawal of consent, loss to follow-up, or study termination by the sponsor.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0/1 Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions Scheduled for Resection to Evaluate Central Nervous System (CNS) Penetration With PK-triggered Expansion Cohort
Actual Study Start Date : October 18, 2023
Estimated Primary Completion Date : May 2025
Estimated Study Completion Date : October 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Recurrent high-grade glioma participants with EGFR alterations Drug: BDTX-1535
BDTX-1535 is an inhibitor of EGFR mutations
Experimental: Recurrent high-grade glioma participants with EGFR fusion Drug: BDTX-1535
BDTX-1535 is an inhibitor of EGFR mutations


Outcome Measures
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Primary Outcome Measures :
  1. Unbound concentration of BDTX-1535 in tumor tissue [ Time Frame: Phase 0 Intraoperative Sample ]
    Unbound BDTX-1535 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue

  2. Total concentration of BDTX-1535 in tumor tissue [ Time Frame: Phase 0 Intraoperative Sample ]
    Total BDTX-1535 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue

  3. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    Rate of 6-month progression-free survival


Secondary Outcome Measures :
  1. Concentration of BDTX-1535 in CSF [ Time Frame: Phase 0 Intraoperative sample ]
    BDTX-1535 level in CSF will be determined

  2. Percentage of pEGFR positive cells in tumor tissue [ Time Frame: Phase 0 Intraoperative Sample ]
    Expression of pEGFR in BDTX-1535 treated HGG tissue compared to archival tissue.

  3. Percentage of pERK positive cells in tumor tissue [ Time Frame: Phase 0 Intraoperative Sample ]
    Expression of pERK in BDTX-1535 treated HGG tissue compared to archival tissue.

  4. Overall survival (OS) [ Time Frame: Up to 12 months after the last study dose ]
    Median overall survival in participants with demonstrated PK effect

  5. Safety and tolerability - adverse events [ Time Frame: Up to 30 days after the last study dose ]
    Number of adverse events through study completion

  6. Safety and tolerability - death [ Time Frame: 24 months ]
    Number of deaths

  7. Clinical laboratory abnormalities per CTCAE [ Time Frame: Up to 30 days after the last study dose ]
    Incidence of Clinical laboratory abnormalities per CTCAE


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants who have had a prior resection of diagnosed HGG (2021 WHO grade 3 and 4), defined as participants who have progressed on or following standard therapy, which includes maximal surgical resection, temozolomide, and fractionated radiotherapy.
  • Adequate archival or biopsy tissue available for testing of EGFR alterations.
  • Participants must have measurable disease preoperatively.
  • Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Ability to swallow oral medications.
  • Participant has adequate bone marrow and organ function

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Known allergic reactions to components of the BDTX-1535.
  • Known to have active (acute or chronic) or uncontrolled severe infection, liver disease such as cirrhosis, decompensated liver disease, and active and chronic hepatitis, as determined by the investigator.
  • Known active systemic bacterial infection, fungal infection, or detectable viral infection .
  • Significant cardiovascular disease.
  • Symptomatic or radiographic leptomeningeal disease.
  • Participant has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study .
  • Concurrent use of prohibited medications.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06072586


Contacts
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Contact: Phase 0 Navigator 602-406-8605 research@ivybraintumorcenter.org

Locations
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United States, Arizona
St. Joseph's Hospital and Medical Center Recruiting
Phoenix, Arizona, United States, 85013
Contact: Phase 0 Navigator    602-406-8605    research@ivybraintumorcenter.org   
Principal Investigator: Nader Sanai, MD         
Sponsors and Collaborators
St. Joseph's Hospital and Medical Center, Phoenix
Ivy Brain Tumor Center
Barrow Neurological Institute
Investigators
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Principal Investigator: Nader Sanai, MD Chief Scientific Officer/Director of the Ivy Brain Tumor Center
More Information
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Additional Information:

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Responsible Party: St. Joseph's Hospital and Medical Center, Phoenix
ClinicalTrials.gov Identifier: NCT06072586    
Other Study ID Numbers: 2023-20
24-500-090-34-38 ( Other Identifier: SJHMC )
First Posted: October 10, 2023    Key Record Dates
Last Update Posted: November 28, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue