First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Recruiting · NCT05768139 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
AbemaciclibAnastrozoleExemestaneFulvestrantImlunestrantLetrozoleMetforminPalbociclibRibociclibSTX-478Tamoxifen
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
- Key
Exclusion criteria
- Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied
- Has symptomatic brain or spinal metastases
- Has an established diagnosis of uncontrolled diabetes mellitus (defined as HbA1c ≥8% and/or FBG ≥140 mg/dL \[7.7 mmol/L\] and/or requiring or required insulin).
- Has had prior treatment with PI3K/AKT/mTOR inhibitor(s), except in certain circumstances
- Has had treatment with any local or systemic antineoplastic therapy or investigational anticancer agent within 14 days or 4 half-lives, whichever is longer, prior to the initiation of study treatment up to a maximum washout period of 28 days. Endocrine therapy does not require a washout period if the patient is enrolling in a cohort with the same combination endocrine therapy.
- Has toxicities from previous anticancer therapies that have not resolved to baseline levels or CTCAE grade ≤1, with the exception of alopecia and peripheral neuropathy.
- Has had radiotherapy within 14 days before the initiation of study treatment
Where it is running
60 locations listed across 17 US states.
- Ellison Clinic at Saint John's - Los Angeles, California, United States
- UCSF Medical Center at Mission Bay - San Francisco, California, United States
- University of Colorado Cancer Center - Aurora, Colorado, United States
- Yale-New Haven Hospital - New Haven, Connecticut, United States
- Florida Cancer Specialists ORLANDO/DDU - Lake Mary, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States
- Winship Cancer Institute, Emory University - Atlanta, Georgia, United States
- University of Iowa - Iowa City, Iowa, United States
- Louisiana State University Health Sciences Center - New Orleans, Louisiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Barbara Ann Karmanos Cancer Institute - Detroit, Michigan, United States
- START Midwest - Grand Rapids, Michigan, United States
- Saint Luke's Cancer Institute - Kansas City, Missouri, United States
- Washington University - St Louis, Missouri, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- UH Cleveland Medical Center - Cleveland, Ohio, United States
- Stefanie Spielman Comprehensive Breast Center - Columbus, Ohio, United States
- Providence Cancer Institute Franz Clinic - Portland, Oregon, United States
- The West Clinic, PLLC dba West Cancer Center - Germantown, Tennessee, United States
- Sarah Cannon Research Institute - Nashville, Tennessee, United States
- Mary Crowley Cancer Research Center - Dallas, Texas, United States
- Texas Oncology-Baylor Charles A. Sammons Cancer Center - Dallas, Texas, United States
- University of Texas Southwestern - Dallas, Texas, United States
- University of Texas MD Anderson Cancer Center - Houston, Texas, United States
- START San Antonio - San Antonio, Texas, United States
- START Mountain Region - West Valley City, Utah, United States
- USO-Virginia Cancer Specialists, PC - Fairfax, Virginia, United States
- Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo - Alessandria, Italy
- Netherlands Cancer Institute - Amsterdam, Netherlands
- Institut Jules Bordet - Anderlecht, Belgium
- Hospital Quiron Barcelona - Barcelona, Spain
- South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos - Barcelona, Spain
- Instituto Oncologico Dr Rosell (IOR) - Barcelona, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Spain
- Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - Bordeaux, France
- Spedali Civili di Brescia - Brescia, Italy
- Mater Misericordiae Hospital - Dublin, Ireland
- Universitätsklinikum Erlangen - Erlangen, Germany
- National Hospital Organization Kyushu Cancer Center - Fukuoka, Japan
- Kansai Medical University Hospital - Hirakata, Japan
- Kyoto University Hospital - Kyoto, Japan
- The Cancer Institute Hospital of JFCR - Kōtō City, Japan
- UZ Leuven - Leuven, Belgium
- Hospital San Pedro - Logroño, Spain
- Centre Leon Berard - Lyon, France
- MD Anderson Cancer Center - Madrid, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- Hospital Universitario Fundación Jiménez Díaz - Madrid, Spain
- Hospital Universitario HM Sanchinarro - Madrid, Spain
- Institut Paoli-Calmettes - Marseille, France
- Istituto Nazionale per lo Studio e la Cura dei Tumori - Milan, Italy
- Istituto Europeo di Oncologia - Milan, Italy
- Fondazione IRCCS San Gerardo dei Tintori - Monza, Italy
- Centre Antoine-Lacassagne - Nice, France
- Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara - Pisa, Italy
- Hospital Universitario Quironsalud Madrid - Pozuelo de Alarcón, Spain
- Ospedale Santa Maria delle Croci - Ravenna, Italy
- Hospital Universitari Sant Joan de Reus - Reus, Spain
- Fondazione Policlinico Universitario Agostino Gemelli - Roma, Italy
Showing 60 of 65 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →