Clinical Trials Logo

Clinical Trial Summary

BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma (GBM) expressing EGFR alterations (Phase 1 only). All patients will self-administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently enrolling.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05256290
Study type Interventional
Source Black Diamond Therapeutics, Inc.
Contact BDTX Clinical Trial Navigation Service
Phone (866) 955-4397
Email blackdiamondtx@careboxhealth.com
Status Recruiting
Phase Phase 1/Phase 2
Start date March 31, 2022
Completion date June 2026

See also
  Status Clinical Trial Phase
Terminated NCT03087448 - Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC) Phase 1
Recruiting NCT05042375 - A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer Phase 3
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Terminated NCT05414123 - A Therapy Treatment Response Trial in Patients With Leptomeningeal Metastases ((LM) Using CNSide
Recruiting NCT05059444 - ORACLE: Observation of ResiduAl Cancer With Liquid Biopsy Evaluation
Recruiting NCT05919537 - Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation Phase 1
Recruiting NCT05009836 - Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC Phase 3
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03219970 - Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Recruiting NCT05949619 - A Study of BL-M02D1 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer or Other Solid Tumors Phase 1/Phase 2
Recruiting NCT04054531 - Study of KN046 With Chemotherapy in First Line Advanced NSCLC Phase 2
Withdrawn NCT03519958 - Epidermal Growth Factor Receptor (EGFR) T790M Mutation Testing Practices in Hong Kong
Completed NCT03384511 - The Use of 18F-ALF-NOTA-PRGD2 PET/CT Scan to Predict the Efficacy and Adverse Events of Apatinib in Malignancies. Phase 4
Terminated NCT02580708 - Phase 1/2 Study of the Safety and Efficacy of Rociletinib in Combination With Trametinib in Patients With mEGFR-positive Advanced or Metastatic Non-small Cell Lung Cancer Phase 1/Phase 2
Completed NCT01871805 - A Study of Alectinib (CH5424802/RO5424802) in Participants With Anaplastic Lymphoma Kinase (ALK)-Rearranged Non-Small Cell Lung Cancer (NSCLC) Phase 1/Phase 2
Terminated NCT04042480 - A Study of SGN-CD228A in Advanced Solid Tumors Phase 1
Recruiting NCT05919641 - LIVELUNG - Impact of CGA in Patients Diagnosed With Localized NSCLC Treated With SBRT
Completed NCT03656705 - CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma Phase 1