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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06072586
Other study ID # 2023-20
Secondary ID 24-500-090-34-38
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 18, 2023
Est. completion date October 31, 2025

Study information

Verified date November 2023
Source St. Joseph's Hospital and Medical Center, Phoenix
Contact Phase 0 Navigator
Phone 602-406-8605
Email research@ivybraintumorcenter.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date October 31, 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BDTX-1535
BDTX-1535 is an inhibitor of EGFR mutations

Locations

Country Name City State
United States St. Joseph's Hospital and Medical Center Phoenix Arizona

Sponsors (3)

Lead Sponsor Collaborator
St. Joseph's Hospital and Medical Center, Phoenix Barrow Neurological Institute, Ivy Brain Tumor Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unbound concentration of BDTX-1535 in tumor tissue Unbound BDTX-1535 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue Phase 0 Intraoperative Sample
Primary Total concentration of BDTX-1535 in tumor tissue Total BDTX-1535 concentration in Gd-enhancing and Gd-non-enhancing tumor tissue Phase 0 Intraoperative Sample
Primary Progression Free Survival (PFS) Rate of 6-month progression-free survival 6 months
Secondary Concentration of BDTX-1535 in CSF BDTX-1535 level in CSF will be determined Phase 0 Intraoperative sample
Secondary Percentage of pEGFR positive cells in tumor tissue Expression of pEGFR in BDTX-1535 treated HGG tissue compared to archival tissue. Phase 0 Intraoperative Sample
Secondary Percentage of pERK positive cells in tumor tissue Expression of pERK in BDTX-1535 treated HGG tissue compared to archival tissue. Phase 0 Intraoperative Sample
Secondary Overall survival (OS) Median overall survival in participants with demonstrated PK effect Up to 12 months after the last study dose
Secondary Safety and tolerability - adverse events Number of adverse events through study completion Up to 30 days after the last study dose
Secondary Safety and tolerability - death Number of deaths 24 months
Secondary Clinical laboratory abnormalities per CTCAE Incidence of Clinical laboratory abnormalities per CTCAE Up to 30 days after the last study dose
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