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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Black Diamond Therapeutics, Inc.
Study ID
NCT05256290
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Advanced Lung Carcinoma
  • Advanced Non-Small Cell Squamous Lung Cancer
  • EGF-R Positive Non-Small Cell Lung Cancer
  • EGFR-TKI Resistant Mutation
  • Epidermal Growth Factor Receptor C797S
  • Epidermal Growth Factor Receptor G719X
  • Metastatic Lung Cancer
  • Metastatic Lung Non-Small Cell Carcinoma
  • NSCLC
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • silevertinib (BDTX-1535) monotherapy — DRUG
    Silevertinib (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.

Study Details

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 silevertinib (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 silevertinib (BDTX-1535) monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 is currently ongoing.

Key Dates

First listed
Feb 25, 2022
Start date
Mar 31, 2022
Status verified
Dec 2025
Primary completion
Nov 3, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Dose Escalation - Monotherapy (Recruitment Closed)
    * Advanced/metastatic NSCLC with acquired resistance EGFR mutation (eg, C797S), following a 3rd generation EGFR inhibitor in the 1st line setting (in the absence of concurrent T790M). * Advanced/metastatic NSCLC with non-classical EGFR mutation (eg, G719X) following standard-of-care therapy with an EGFR inhibitor * Recurrent GBM with confirmed EGFR alterations (including amplification, mutation, and/or variant)
  • Experimental: Phase 2 Cohort 1: NSCLC EGFR Non-Classical Driver Mutations
    Advanced/metastatic NSCLC with a non-classical driver EGFR mutation following up to 2 lines of therapy with only 1 prior EGFR targeted regimen (third-generation preferred; other approved EGFR inhibitors acceptable)
  • Experimental: Phase 2 Cohort 2: NSCLC EGFR Acquired Resistance (C797S) Mutation
    Advanced/metastatic NSCLC with the acquired resistance C797S EGFR mutation following up to 2 lines of therapy, including only 1 EGFR targeted regimen, which must be a third generation EGFR TKI (eg, osimertinib)
  • Experimental: Phase 2 Cohort 3: Treatment Naive NSCLC EGFR Non-Classical Driver Mutations
    Treatment-naïve (first-line) 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.

Primary Outcome Measure

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 silevertinib (BDTX-1535) [ Time Frame: The first treatment 21-day cycle (Cycle 1) ]

Locations (25)

FacilityCityStateZIPSite coordinators
University of AlabamaBirminghamAlabama35294-
Banner MD Anderson Cancer CenterGilbertArizona85234-
City of Hope Huntington BeachHuntington BeachCalifornia92648-
City of Hope Orange County Lennar Foundation Cancer CenterIrvineCalifornia92618-
Cedars Sinai Medical CenterLos AngelesCalifornia90048-
Sibley Memorial Hospital Johns Hopkins MedicineWashington D.C.District of Columbia20016-
Mayo Clinic- JacksonvilleJacksonvilleFlorida32224-
Miami Cancer Institute - Baptist Health South FloridaMiamiFlorida33176-
UHP- University of Hawaii Cancer CenterHonoluluHawaii96813-
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicagoIllinois60611-
University of Kansas Cancer CenterFairwayKansas66205-
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21224-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Mayo Clinic- RochesterRochesterMinnesota55905-
Siteman Cancer CenterSt LouisMissouri63110-
Columbia University Irving Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
Montefiore Medical CenterThe BronxNew York10461-
UNC Hospitals - Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
University of Pittsburgh Medical Center - Hillman Cancer CenterPittsburghPennsylvania15232-
Tennessee OncologyNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-
Next OcologyFairfaxVirginia22031-
Fred Hutchinson Cancer Center/University of WashingtonSeattleWashington98109-

Find similar trials in Birmingham, AL

By condition
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By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama· Birmingham, ALBanner MD Anderson Cancer Center· Gilbert, AZCity of Hope Huntington Beach· Huntington Beach, CACity of Hope Orange County Lennar Foundation Cancer Center· Irvine, CACedars Sinai Medical Center· Los Angeles, CASibley Memorial Hospital Johns Hopkins Medicine· Washington D.C., DC

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