Phase 1/2 Study of BDTX-1535 in Patients With Glioblastoma or Non-Small Cell Lung Cancer With EGFR Mutations

Launched by BLACK DIAMOND THERAPEUTICS, INC. · Feb 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BDTX-1535 for adults with specific types of lung cancer and glioblastoma, which is a type of brain cancer. The trial aims to find out how safe BDTX-1535 is, how well it works, and the best dose to give patients. Participants will take BDTX-1535 by mouth in cycles lasting 21 days. The trial is currently looking for patients who have advanced non-small cell lung cancer with certain gene mutations that make their cancer hard to treat with standard therapies, or who have glioblastoma with specific changes in their cancer cells.

To be eligible for the trial, participants should have measurable cancer disease that has progressed after previous treatments, and they should not have certain resistant mutations in their tumors. Also, they need to be in generally good health with a life expectancy of at least three months. After joining the trial, participants can expect regular check-ups and monitoring to assess how well the treatment is working and to manage any side effects. This trial is important because it explores a potential new option for patients whose cancer has not responded to existing therapies.

Gender

ALL

Eligibility criteria

• Phase 2 Eligibility:
• Key Inclusion Criteria Required for locally advanced or metastatic NSCLC:
• • Measurable disease by RECIST 1.1 criteria.
• • Adequate bone marrow or organ function.
• • Life expectancy of ≥ 3 months.
• • Sufficient performance status.
• • Confirmed NSCLC, without small cell lung cancer transformation with or without brain metastases.
• * Disease progression following or intolerance of standard of care (excluding patients in the treatment-naïve non-classical driver cohort):
• • Cohort 1 (Non-Classical driver cohort): Advanced/metastatic NSCLC with a non-classical driver EGFR mutation (eg, G719X) following up to 2 lines of therapy with only 1 prior EGFR TKI regimen (third-generation preferred; other approved EGFR TKI acceptable).
• • Cohort 2 (Acquired resistance C797S cohort): Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only one EGFR TKI, which must be a third generation EGFR TKI (eg, osimertinib).
• • Cohort 3 (First-line non-classical driver cohort): Treatment-naïve advanced/metastatic NSCLC with a non-classical driver EGFR mutation (1 cycle of chemotherapy or immune checkpoint inhibitor are permitted). Patients with co-occurring L858R mutations and a non-classical mutation are eligible for inclusion.
• * Identification of one (or more) of the following EGFR mutations by Next Generation Sequencing (NGS) as determined by a local assay performed in a validated laboratory in the absence of other known resistance mutations (eg, T790M, MET):
• • Non-classical driver EGFR mutations (eg, L861R, S768I, G719X).
• • EGFR acquired resistance mutation (eg, C797S) to a 3rd generation EGFR TKI.
• • For Phase 2, dose expansion, patients in Cohort 1 who received 3rd generation EGFR TKI (eg, osimertinib), the NGS report within 6 months prior to the start of Screening is acceptable. For patients in Cohort 2, the NGS report must be from the last disease progression on the immediate prior therapy. For patients in Cohort 3, the NGS report must be at the time of diagnosis.
• Key Exclusion Criteria:
• • Known resistant mutations in tumor tissue or by liquid biopsy (eg, T790M, MET).
• • Received more than 1 EGFR TKI therapy (ie, erlotinib or gefitinib) for the treatment of metastatic or recurrent EGFR NSCLC.
• • Any history of interstitial lung disease related to EGFR TKI use.
• • Symptomatic or radiographic leptomeningeal disease.
• • Symptomatic brain metastases or spinal cord compression requiring urgent clinical intervention.
• • Unresolved toxicity from prior therapy.
• • Significant cardiovascular disease.
• • Major surgery within 4 weeks of study entry or planned during study.
• • Ongoing or recent anticancer therapy or radiation therapy.
• • Evidence of malignancy (other than study-specific malignancies) requiring active therapy within the next 2 years.
• • Active hepatitis B or C infection and/or known human immunodeficiency virus (HIV) carrier.
• • Poorly controlled gastrointestinal disorders.