First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Start Date
4/17/2023
Completion Date
7/1/2030
Summary
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
STX-478
Fulvestrant
Ribociclib
Palbociclib
Letrozole
Anastrozole
Exemestane
Tamoxifen
Abemaciclib
Imlunestrant
Metformin
Conditions
Locations
Ellison Clinic at Saint John's
Los Angeles, California 90064
United States
UCSF Medical Center at Mission Bay
San Francisco, California 94143
United States
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Yale-New Haven Hospital
New Haven, Connecticut 06510
United States
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida 32746
United States
Moffitt Cancer Center
Tampa, Florida 33612
United States
Winship Cancer Institute, Emory University
Atlanta, Georgia 30322
United States
University of Iowa
Iowa City, Iowa 52242
United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana 70112
United States
Massachusetts General Hospital
Boston, Massachusetts 02115
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan 48201
United States
START Midwest
Grand Rapids, Michigan 49546
United States
Saint Luke's Cancer Institute
Kansas City, Missouri 64111-3220
United States
Washington University
St Louis, Missouri 63110
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
UH Cleveland Medical Center
Cleveland, Ohio 44106
United States
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio 43212
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
United States
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee 38138
United States
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Mary Crowley Cancer Research Center
Dallas, Texas 75230
United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas 75246-2092
United States
University of Texas Southwestern
Dallas, Texas 75390
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
START San Antonio
San Antonio, Texas 78229
United States
START Mountain Region
West Valley City, Utah 84119
United States
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Institut Jules Bordet
Anderlecht, 1070
Belgium
UZ Leuven
Leuven, 3000
Belgium
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33000
France
Centre Leon Berard
Lyon, 69008
France
Institut Paoli-Calmettes
Marseille, 13009
France
Centre Antoine-Lacassagne
Nice, 06189
France
Institut Claudius Regaud
Toulouse, 31059
France
Gustave Roussy
Villejuif, 94805
France
Universitätsklinikum Erlangen
Erlangen, 91054
Germany
Mater Misericordiae Hospital
Dublin,
Ireland
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, 15100
Italy
Spedali Civili di Brescia
Brescia, 25123
Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, 20133
Italy
Istituto Europeo di Oncologia
Milan, 20141
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, 20900
Italy
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, 56126
Italy
Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 168
Italy
Centro Ricerche Cliniche di Verona s.r.l.
Verona, 37134
Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka, 811-1395
Japan
Kansai Medical University Hospital
Hirakata, 573-1191
Japan
The Cancer Institute Hospital of JFCR
Kōtō City, 135-8550
Japan
Kyoto University Hospital
Kyoto, 606-8507
Japan
Netherlands Cancer Institute
Amsterdam, 1066CX
Netherlands
Erasmus MC
Rotterdam, 3015GD
Netherlands
Hospital Quiron Barcelona
Barcelona, 08023
Spain
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, 08023
Spain
Instituto Oncologico Dr Rosell (IOR)
Barcelona, 08028
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital San Pedro
Logroño, 26006
Spain
MD Anderson Cancer Center
Madrid, 28033
Spain
Hospital Clinico San Carlos
Madrid, 28040
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario HM Sanchinarro
Madrid, 28050
Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223
Spain
Hospital Universitari Sant Joan de Reus
Reus, 43204
Spain
Hospital Universitario Virgen Macarena
Seville, 41009
Spain