Phase 1/2 Study of BDTX-1535 for Patients with Glioblastoma or Non-Small Cell Lung Cancer with EGFR Mutations
Sponsor: Black Diamond Therapeutics, Inc.
ClinicalTrials ID:NCT05256290
This clinical trial is testing a new drug, BDTX-1535, to see if it is safe and effective for treating adults with certain types of advanced lung cancer or brain cancer. The study is currently enrolling patients for Phase 2.
Patient Parameters
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Program Overview
This study is exploring a new treatment called BDTX-1535 for adults with advanced non-small cell lung cancer (NSCLC) that has specific EGFR mutations, or glioblastoma (a type of brain cancer) with EGFR changes. The trial is in two parts: Phase 1, which is now complete, focused on finding the right dose and checking safety. Phase 2 is currently enrolling and aims to further evaluate the drug's effects. Participants will take the medication by mouth in 21-day cycles.
Eligibility Criteria
Exclusion Criteria
- Have known resistant mutations in the tumor or from a blood test, such as T790M or MET.
- Have received more than one EGFR-targeted therapy for metastatic or recurrent lung cancer.
- Have a history of lung disease related to EGFR-targeted therapy.
- Have symptoms or imaging showing cancer spread to the brain or spinal cord that needs urgent treatment.
- Have unresolved side effects from previous treatments.
- Have significant heart disease.
- Have had major surgery within 4 weeks before starting the study or plan to have surgery during the study.
- Are currently receiving or have recently received other cancer treatments or radiation.
- Have another type of cancer that needs treatment within the next 2 years.
- Have active hepatitis B or C, or are known to have HIV.
- Have poorly controlled digestive disorders.
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