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DRUG:

BDTX-1535

i
Other names: BDTX-1535
Company:
Black Diamond Therap
Drug class:
EGFR inhibitor, EGFR MasterKey inhibitor
Related drugs:
3ms
Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
P1, N=34, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | N=22 --> 34
Enrollment change
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EGFR (Epidermal growth factor receptor)
|
BDTX-1535
6ms
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (clinicaltrials.gov)
P1/2, N=200, Recruiting, Black Diamond Therapeutics, Inc. | Trial completion date: Mar 2025 --> Jun 2026 | Trial primary completion date: Jun 2024 --> Jul 2025
Trial completion date • Trial primary completion date
|
Tagrisso (osimertinib) • BDTX-1535
11ms
Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations (clinicaltrials.gov)
P1/2, N=200, Recruiting, Black Diamond Therapeutics, Inc. | Phase classification: P1 --> P1/2 | N=120 --> 200
Phase classification • Enrollment change
|
EGFR mutation • EGFR L858R • EGFR T790M • EGFR C797S • EGFR G719X
|
Tagrisso (osimertinib) • BDTX-1535
12ms
Study of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Participants With EGFR Alterations or Fusions (clinicaltrials.gov)
P1, N=22, Recruiting, St. Joseph's Hospital and Medical Center, Phoenix | Not yet recruiting --> Recruiting
Enrollment open
|
EGFR (Epidermal growth factor receptor)
|
BDTX-1535
1year
New P1 trial
|
EGFR (Epidermal growth factor receptor)
|
BDTX-1535
2years
Anti-tumor activity of BDTX-1535, an irreversible CNS penetrant inhibitor of multiple EGFR extracellular domain alterations, in preclinical glioblastoma models (AACR-NCI-EORTC 2022)
RWE findings demonstrate a heterogeneous EGFR mutational profile in GBM patients, with persistent prevalence over time. BDTX-1535 is currently in a phase I clinical study (NCT05256290).
Preclinical
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EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR amplification • EGFR wild-type • EGFR mutation + EGFR amplification • EGFRvIII expression
|
Tempus xT Assay
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BDTX-1535
3years
BDTX-1535 Goes After Osimertinib Resistance. (PubMed, Cancer Discov)
According to a preclinical report, the investigational tyrosine kinase inhibitor BDTX-1535 may mitigate resistance to osimertinib, the standard of care for EGFR-mutant non-small cell lung cancer. It could also potentially treat central nervous system metastases, having shown preclinical efficacy in glioblastoma.
Journal
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EGFR (Epidermal growth factor receptor)
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EGFR mutation
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Tagrisso (osimertinib) • BDTX-1535