Non-Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 1/2 Study to Assess BDTX-1535, an Oral EGFR Inhibitor, in Patients With Glioblastoma or Non-Small Cell Lung Cancer
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 multiforme (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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | March 2025 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). - 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. - NGS test must be obtained after progression on the most recent therapy; at the time of diagnosis for the patients in Cohort 3 only. 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. |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical | Seoul | |
Korea, Republic of | National Cancer Center | Seoul | |
Korea, Republic of | Samsung Comprehensive Cancer Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul | |
United States | Beverly Hills Cancer Center | Beverly Hills | California |
United States | University of Alabama | Birmingham | Alabama |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Montefiore Medical Center | Bronx | New York |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Mary Crowley Cancer Research | Dallas | Texas |
United States | HealthOne Denver | Denver | Colorado |
United States | City of Hope Comprehensive Cancer Center (Duarte Campus) | Duarte | California |
United States | Next Ocology | Fairfax | Virginia |
United States | Prisma Health | Greenville | South Carolina |
United States | City of Hope Huntington Beach | Huntington Beach | California |
United States | City of Hope Orange County Lennar Foundation Cancer Center | Irvine | California |
United States | University of Kansas Cancer Center | Kansas City | Kansas |
United States | Valkyrie Clinical Trials | Los Angeles | California |
United States | Baptist Health Miami | Miami | Florida |
United States | Tennessee Oncology | Nashville | Tennessee |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Stephenson Cancer Center | Oklahoma City | Oklahoma |
United States | Thomas Jefferson University/Sidney Kimmel Cancer Center | Philadelphia | Pennsylvania |
United States | Siteman Cancer Center | Saint Louis | Missouri |
United States | Fred Hutchinson Cancer Center/University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Black Diamond Therapeutics, Inc. |
United States, Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1 Dose Escalation: To determine the maximum tolerated dose (MTD), if one exists, and the preliminary recommended Phase 2 dose(s) (RP2D[s]) of BDTX-1535 | Dose-limiting toxicities (DLTs) in Cycle 1 | The first treatment 21-day cycle (Cycle 1) | |
Primary | Phase 2: To assess antitumor efficacy of BDTX-1535 | Objective response rate (ORR) as assessed by Investigator using RECIST version 1.1 | Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days) | |
Secondary | Phase 1 and Phase 2: Incidence and severity of treatment-emergent adverse events (TEAEs) | Through study completion, approximately 1 year | ||
Secondary | Phase 1 and Phase 2: To characterize the plasma concentration of BDTX-1535 following single and multiple dosing | Cycle 1 Days 1, 2, 15, and 16, Cycles 2 to 5 Day 1, and Day 1 of every other cycle thereafter to study completion, approximately 1 year (each cycle is 21 days) | ||
Secondary | Phase 1: To assess the preliminary antitumor activity of BDTX-1535 by objective response as assessed by RECIST version 1.1 (for patients with NSCLC) or Response Assessment in Neuro-oncology (RANO) (for patients with GBM) | Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days) | ||
Secondary | Phase 1: To assess the effect of tablet formulation on the plasma concentration of BDTX-1535 | Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days) | ||
Secondary | Phase 1: To assess the effect of food on the plasma concentration of BDTX-1535 | Two timepoints during the first cycle: Cycle 0 (7 days prior to Cycle 1 Day 1) and Cycle 1 Day 1 only (each cycle is 21 days) | ||
Secondary | Phase 2: To assess duration of tumor response by RECIST version 1.1 | Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days) | ||
Secondary | Phase 2: To assess progression free survival by RECIST version 1.1 | Day 1 every 2 cycles starting at Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days) | ||
Secondary | Phase 2: To evaluate CNS ORR by RANO for brain metastases criteria (RANO-BM) | Day 1 every 2 cycles starting on Cycle 3 Day 1 to study completion, approximately 1 year (each cycle is 21 days) | ||
Secondary | Phase 2: To assess NSCLC disease-related symptoms and change of symptoms with BDTX-1535 treatment | Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ); Verbal rating scale used (for example: Never/Rarely/Sometimes/Often/Always) | At select timepoints: Cycle 1 Day, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, and at study completion, approximately 1 year (each cycle is 21 days) | |
Secondary | Phase 2: To assess treatment related side effects with BDTX-1535 | National Cancer Institute Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE) Survey: Rating scale used (for example never/rarely/occasionally/frequently/almost constantly) | At select timepoints: Cycle 1 Day, Cycle 3 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, and at study completion, approximately 1 year (each cycle is 21 days) | |
Secondary | Phase 2: To determine the optimal dosage of BDTX-1535 (100 mg or 200 mg daily dose) | At least the first treatment 21-day cycle (Cycle 1) for select patients enrolled into the Phase 2 |
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