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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05256290
Other study ID # BDTX-1535-101
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date March 31, 2022
Est. completion date June 2026

Study information

Verified date May 2024
Source Black Diamond Therapeutics, Inc.
Contact BDTX Clinical Trial Navigation Service
Phone (866) 955-4397
Email blackdiamondtx@careboxhealth.com
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2026
Est. primary completion date July 2025
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). 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BDTX-1535 monotherapy
BDTX-1535 is a 4th generation irreversible brain penetrant EGFR MasterKey inhibitor, which targets a family of oncogenic EGFR classical and non-classical driver and resistance mutations in NSCLC.

Locations

Country Name City State
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 Texas Oncology - Baylor Charles A. Sammons Cancer Center 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 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
United States Johns Hopkins Bayview Medical Center Washington District of Columbia
United States Sibley Memorial Hospital Johns Hopkins Medicine Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Black Diamond Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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