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.
The Phase 0 component will include treatment of rHGG (Arms A and B) and nGBM participants (Arms C, D, and E) with BDTX-1535 prior to a planned tumor resection. During surgery, blood, tumor, and CSF samples will be collected to measure the amount of drug that is present in the samples. Arm A includes ascending dose levels with two cohorts, and Arm C includes two dose level cohorts to determine the Optimal Biological Dose (OBD). The Phase 1 component will include treatment in different dose regimens. Participants with tumors demonstrating PK response (Arms A, B, and C) or PD response (Arms D and E) will continue treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
82
BDTX-1535 is an inhibitor of EGFR mutations
During Phase 1, BDTX-1535 concurrently with standard of care upfront RT, followed by adjuvant monotherapy with BDTX-1535 continuously in 28-day cycles after RT.
During Phase 1, BDTX-1535 concurrently with standard of care upfront RT and TMZ, followed by adjuvant BDTX-1535 combined with standard of care TMZ continuously in 28-day cycles after RT.
Chandler Regional Medical Center
Chandler, Arizona, United States
RECRUITINGSt. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
RECRUITINGUnbound BDTX-1535 Concentration in Tumor Tissue
Unbound BDTX-1535 concentration in Gd enhancing and Gd non-enhancing tumor tissue will be determined by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.
Time frame: Intraoperative
Total BDTX-1535 Concentration in Tumor Tissue
Total BDTX-1535 concentration in Gd enhancing and Gd non-enhancing tumor tissue will be determined by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.
Time frame: Intraoperative
Incidence of DLTs Observed
Considered DLTs: Hem toxicity: 8+ days ≥G4 neutropenia/febrile neutropenia; ≥G4, or ≥G3 with clinically significant bleeding, thrombocytopenia; ≥G3 anemia requiring transfusion. Non-hem lab abnormalities: Any AR ≥G3 of ALT/AST or increase in ALT/AST \>3x ULN with concurrent increase in total bilirubin \>2x ULN (per Hy's Law) in pt with baseline \<G1 ALT/AST; Any AR ≥G3 of ALT/AST \>2x baseline or 10x ULN in pt with baseline \>G2 ALT/AST due to liver mets; Non-hem dose limiting toxicity ≥G3 (per Investigator; except for G3 nausea, vomiting, or diarrhea lasting \<72 hrs with adequate antiemetic/supportive care; G3 fatigue or anorexia lasting \<1 week; ≥G3 electrolyte abnormality lasting up to 72 hrs, isn't clinically complicated, and resolves spontaneously or responds to intervention). AR requiring dose reduction in C1, causes \>2 week delay of C2, causes 8+ day dose interruption in C1. DLTs exclude: alopecia; lymphopenia; isolated lab changes w/o clinical sequelae or significance
Time frame: From day of first dose to the end of concurrent RT treatment at 10 weeks
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by NCI-CTCAE v5
AEs that occur while participants are on study treatment.
Time frame: Day of first dose until 30 days after final day of participation
Number of Participants with Treatment-Related Adverse Events (TRAEs) as Assessed by NCI-CTCAE v5
Causality will be graded using these categories: definitely related, probably related, potentially related, unlikely to be related, and not related. Causality will be assessed by the clinician who examines and evaluates the participant based on temporal relationship and their clinical judgment. The Medical Monitor will also provide causal relationship for any Serious Adverse Events (SAEs).
Time frame: Day of first dose until 30 days after final day of participation
Number of Participants with Abnormal Laboratory Values as Assessed per NCI-CTCAE v5
Significant changes from participant's baseline established during screening.
Time frame: Day of first dose until 30 days after final day of participation
BDTX-1535 Concentration in CSF
BDTX-1535 concentration in CSF will be determined by a validated liquid chromatography-mass spectrometry (LC-MS/MS) method.
Time frame: Intraoperative
Change in pEGFR Expression in Tumor Tissue
BDTX-1535 treated tumor tissue collected during Phase 0 surgery will be compared to archival tissue (baseline) to determine change in pEGFR expression.
Time frame: Baseline and intraoperative
Change in pERK Expression in Tumor Tissue
BDTX-1535 treated tumor tissue collected during Phase 0 surgery will be compared to archival tissue (baseline) to determine change in pERK expression.
Time frame: Baseline and intraoperative
6-Month Progression Free Survival (PFS6) Rate
PFS6 rate will be determined in participants who take at least one dose of study treatment.
Time frame: From the date of Phase 0 surgery to date of disease recurrence or death, whichever occurs first, assessed up to 12 months after study completion
Median Progression Free Survival (PFS)
Median PFS will be determined in participants with positive PK or PD response.
Time frame: From the date of Phase 0 surgery until the date of death due to any cause, assessed for up to 12 months after study completion
Median Overall Survival (OS)
Median OS will be determined in participants with positive PK or PD response.
Time frame: From the date of Phase 0 surgery until the date of death due to any cause, assessed for up to 12 months after study completion
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