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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

March 31, 2022

Primary Completion Date

July 31, 2025

Study Completion Date

June 30, 2026

Conditions
Non-Small Cell Lung CancerAdvanced Non-Small Cell Squamous Lung CancerMetastatic Lung Non-Small Cell CarcinomaMetastatic Lung CancerNSCLCAdvanced Lung CarcinomaEpidermal Growth Factor Receptor C797SEpidermal Growth Factor Receptor G719XEGF-R Positive Non-Small Cell Lung CancerEGFR-TKI Resistant Mutation
Interventions
DRUG

silevertinib (BDTX-1535) monotherapy

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.

Trial Locations (41)

10021

Memorial Sloan Kettering Cancer Center, New York

10032

Columbia University Irving Medical Center, New York

10461

Montefiore Medical Center, The Bronx

15232

University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh

19107

Thomas Jefferson University/Sidney Kimmel Cancer Center, Philadelphia

20016

Sibley Memorial Hospital Johns Hopkins Medicine, Washington D.C.

20817

The Center for Cancer and Blood Disorders, Bethesda

21224

Johns Hopkins Bayview Medical Center, Baltimore

22031

Inova Schar Cancer Institute, Fairfax

Next Ocology, Fairfax

27514

UNC Hospitals - Lineberger Comprehensive Cancer Center, Chapel Hill

27705

Durham VA Medical Center, Durham

30322

Emory Winship Cancer Center, Atlanta

32224

Mayo Clinic- Jacksonville, Jacksonville

32806

Orlando Health Cancer Institute, Orlando

33176

Miami Cancer Institute - Baptist Health South Florida, Miami

35294

University of Alabama, Birmingham

37203

Tennessee Oncology, Nashville

38138

The West Clinic PLLC, dba West Cancer Center, Germantown

43210

Ohio State Comprehensive Cancer Center, Columbus

44195

Cleveland Clinic, Cleveland

46202

Indiana University, Indianapolis

55905

Mayo Clinic- Rochester, Rochester

60611

Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago

63110

Siteman Cancer Center, St Louis

66205

University of Kansas Cancer Center, Fairway

75230

Mary Crowley Cancer Research, Dallas

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

77030

The University of Texas MD Anderson Cancer Center, Houston

80124

Rocky Mountain Cancer Center, Lone Tree

85234

Banner MD Anderson Cancer Center, Gilbert

90048

Cedars Sinai Medical Center, Los Angeles

90067

Valkyrie Clinical Trials, Los Angeles

91010

City of Hope Comprehensive Cancer Center (Duarte Campus), Duarte

92618

City of Hope Orange County Lennar Foundation Cancer Center, Irvine

92648

City of Hope Huntington Beach, Huntington Beach

96813

UHP- University of Hawaii Cancer Center, Honolulu

98109

Fred Hutchinson Cancer Center/University of Washington, Seattle

02115

Dana-Farber Cancer Institute, Boston

03756

Dartmouth Hitchcock Medical Center, Lebanon

M5G 2M9

Princess Margaret Cancer Center- University Health Network, Toronto

All Listed Sponsors
lead

Black Diamond Therapeutics, Inc.

INDUSTRY