First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has an advanced or refractory solid tumor malignancy that is metastatic or locally advanced and unresectable (as specified by Cohort)
• Has a new or recent tumor biopsy (collected at screening, if feasible) or will provide an adequate tissue sample prior to screening
• Has a tumor that harbors a documented PI3Kα mutation (cohort specific criterion for cohort-specific mutation types)
• Is ≥18 years of age at the time of signing the ICF
• Has an ECOG performance status score of 0 or 1 at screening
• Has adequate organ function as defined per protocol
Locations
United States
California
The Angeles Clinic & Research Institute
RECRUITING
Los Angeles
UCSF Medical Center at Mission Bay
RECRUITING
San Francisco
Colorado
University of Colorado Cancer Center
RECRUITING
Aurora
Connecticut
Yale-New Haven Hospital
COMPLETED
New Haven
Florida
Florida Cancer Specialists ORLANDO/DDU
RECRUITING
Lake Mary
Moffitt Cancer Center
RECRUITING
Tampa
Georgia
Winship Cancer Institute, Emory University
NOT_YET_RECRUITING
Atlanta
Iowa
University of Iowa
RECRUITING
Iowa City
Louisiana
Louisiana State University Health Sciences Center
RECRUITING
New Orleans
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Barbara Ann Karmanos Cancer Institute
RECRUITING
Detroit
START Midwest
RECRUITING
Grand Rapids
Missouri
Saint Luke's Cancer Institute
RECRUITING
Kansas City
Washington University
NOT_YET_RECRUITING
St Louis
New York
Memorial Sloan Kettering Cancer Center
RECRUITING
New York
Ohio
UH Cleveland Medical Center
RECRUITING
Cleveland
Stefanie Spielman Comprehensive Breast Center
RECRUITING
Columbus
Oklahoma
University of Oklahoma Health Sciences Center
RECRUITING
Oklahoma City
Oregon
Providence Cancer Institute Franz Clinic
RECRUITING
Portland
Tennessee
The West Clinic, PLLC dba West Cancer Center
RECRUITING
Germantown
Sarah Cannon Research Institute
RECRUITING
Nashville
Texas
Mary Crowley Cancer Research Center
COMPLETED
Dallas
Texas Oncology-Baylor Charles A. Sammons Cancer Center
RECRUITING
Dallas
University of Texas Southwestern
NOT_YET_RECRUITING
Dallas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
START San Antonio
RECRUITING
San Antonio
Utah
START Mountain Region
RECRUITING
West Valley City
Virginia
USO-Virginia Cancer Specialists, PC
RECRUITING
Fairfax
Vermont
University of Vermont Medical Center
NOT_YET_RECRUITING
Burlington
Other Locations
Belgium
Institut Jules Bordet
NOT_YET_RECRUITING
Anderlecht
UZ Leuven
NOT_YET_RECRUITING
Leuven
France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
RECRUITING
Bordeaux
Centre Leon Berard
RECRUITING
Lyon
Institut Claudius Regaud
RECRUITING
Toulouse
Gustave Roussy
RECRUITING
Villejuif
Germany
Universitätsklinikum Erlangen
NOT_YET_RECRUITING
Erlangen
Ireland
Mater Misericordiae Hospital
RECRUITING
Dublin
Italy
Istituto Europeo di Oncologia
RECRUITING
Milan
Istituto Nazionale per lo Studio e la Cura dei Tumori
* Cohort A0: Advanced Solid tumors expressing PI3Kα mutations~* Cohort A1: HR+ breast cancer expressing PI3Kα mutations
Experimental: Dose Expansion
* Cohort A1: HR+/HER2- breast cancer expressing PI3Ka mutations~* Cohort A2: Gynecologic cancers~* Cohort A3: Head and Neck Squamous Cell Carcinoma~* Cohorts A4/A5: Other solid tumors not included in Cohorts A1, A2, or A3 expressing PI3Kα mutations~* Cohort A6: Endometrial cancer