Clinical Trials

Multiple clinical trials are evaluating BDTX-1535 in patients with non-small cell lung cancer harboring specific EGFR driver or TKI-resistance mutations (such as C797S and G719X) as well as high-grade gliomas, including newly diagnosed or recurrent glioblastoma. These Early Phase 1 and Phase 1/2 studies assess safety, pharmacokinetics, and preliminary therapeutic efficacy. Sponsored by industry (Black Diamond Therapeutics, Inc.) and academic institutions (St. Joseph's Hospital and Medical Center and the Ivy Brain Tumor Center), recruitment statuses range from active, not recruiting to actively recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06072586 RECRUITING
High Grade Glioma; Glioblastoma
St. Joseph's Hospital and Medical Center, Phoenix
 2023-10-18 EARLY_PHASE1
NCT05256290 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; Advanced Non-Small Cell Squamous Lung Cancer; Metastatic Lung Non-Small Cell Carcinoma; Metastatic Lung Cancer; NSCLC; Advanced Lung Carcinoma; Epidermal Growth Factor Receptor C797S; Epidermal Growth Factor Receptor G719X; EGF-R Positive Non-Small Cell Lung Cancer; EGFR-TKI Resistant Mutation
Black Diamond Therapeutics, Inc.
 2022-03-31 PHASE1; PHASE2
NCT06072586 Recruiting
High Grade Glioma
St. Joseph''s Hospital and Medical Center Phoenix|Ivy Brain Tumor Center|Barrow Neurological Institute
 2023-10-18 Early Phase 1
NCT05256290 Recruiting
Non-Small Cell Lung Cancer|Advanced Non-Small Cell Squamous Lung Cancer|Metastatic Lung Non-Small Cell Carcinoma|Metastatic Lung Cancer|NSCLC|Advanced Lung Carcinoma|Epidermal Growth Factor Receptor C797S|Epidermal Growth Factor Receptor G719X|EGF-R Positive Non-Small Cell Lung Cancer|EGFR-TKI Resistant Mutation
Black Diamond Therapeutics Inc.
 2022-03-31 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-11-20)

Check the BDTX-1535 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BDTX-1535 is a central nervous system-penetrant, irreversible inhibitor that selectively targets oncogenic epidermal growth factor receptor (EGFR) mutants, blocking ATP binding and subsequent receptor autophosphorylation to suppress downstream proliferative kinase signaling cascades. Consequently, this inhibition suppresses cell proliferation and triggers apoptosis in mutant EGFR-driven malignant cells, demonstrating therapeutic relevance for the clinical management of EGFR-mutated non-small cell lung cancer and brain tumors such as glioblastoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.