Actively Recruiting
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Led by Eli Lilly and Company · Updated on 2026-04-23
880
Participants Needed
66
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or older at the time of signing the informed consent form
- Has an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 at screening
- Has adequate organ function as defined per protocol
You will not qualify if you...
- Has history (within 2 years before screening) of a solid tumor or blood cancer that is different 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 fasting blood glucose ≥140 mg/dL [7.7 mmol/L] and/or requiring or required insulin)
- Has had prior treatment with PI3K/AKT/mTOR inhibitors, except in certain circumstances
- Has had treatment with any local or systemic anticancer therapy or investigational agent within 14 days or 4 half-lives (whichever is longer) before starting study treatment, up to a maximum of 28 days; endocrine therapy does not require a washout if enrolling with the same combination endocrine therapy
- Has toxicities from previous anticancer therapies that have not resolved to baseline or grade 1 or less by CTCAE, except alopecia and peripheral neuropathy
- Has had radiotherapy within 14 days before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 66 locations
1
Ellison Clinic at Saint John's
Los Angeles, California, United States, 90064
Actively Recruiting
2
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94143
Actively Recruiting
3
University of Colorado Cancer Center
Aurora, Colorado, United States, 80045
Actively Recruiting
4
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Completed
5
Florida Cancer Specialists ORLANDO/DDU
Lake Mary, Florida, United States, 32746
Completed
6
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
7
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
8
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
9
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
Actively Recruiting
10
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
11
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Terminated
13
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
14
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111-3220
Actively Recruiting
15
Washington University
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
17
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
18
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
19
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States, 97213
Actively Recruiting
20
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States, 38138
Actively Recruiting
21
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
22
Mary Crowley Cancer Research Center
Dallas, Texas, United States, 75230
Completed
23
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246-2092
Actively Recruiting
24
University of Texas Southwestern
Dallas, Texas, United States, 75390
Not Yet Recruiting
25
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
26
START San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
27
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
28
USO-Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Actively Recruiting
29
Institut Jules Bordet
Anderlecht, Belgium, 1070
Not Yet Recruiting
30
UZ Leuven
Leuven, Belgium, 3000
Not Yet Recruiting
31
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, France, 33000
Actively Recruiting
32
Centre Leon Berard
Lyon, France, 69008
Actively Recruiting
33
Institut Paoli-Calmettes
Marseille, France, 13009
Not Yet Recruiting
34
Centre Antoine-Lacassagne
Nice, France, 06189
Not Yet Recruiting
35
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
36
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
37
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Not Yet Recruiting
38
Universitätsmedizin Mannheim
Mannheim, Germany, 68167
Not Yet Recruiting
39
Mater Misericordiae Hospital
Dublin, Ireland
Actively Recruiting
40
Azienda Ospedaliera Nazionale Santi Antonio e Biagio e Cesare Arrigo
Alessandria, Italy, 15100
Not Yet Recruiting
41
Spedali Civili di Brescia
Brescia, Italy, 25123
Not Yet Recruiting
42
Istituto Nazionale per lo Studio e la Cura dei Tumori
Milan, Italy, 20133
Actively Recruiting
43
Istituto Europeo di Oncologia
Milan, Italy, 20141
Actively Recruiting
44
Fondazione IRCCS San Gerardo dei Tintori
Monza, Italy, 20900
Actively Recruiting
45
Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara
Pisa, Italy, 56126
Actively Recruiting
46
Ospedale Santa Maria delle Croci
Ravenna, Italy, 48121
Not Yet Recruiting
47
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 168
Actively Recruiting
48
Centro Ricerche Cliniche di Verona s.r.l.
Verona, Italy, 37134
Actively Recruiting
49
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Actively Recruiting
50
Kansai Medical University Hospital
Hirakata, Japan, 573-1191
Actively Recruiting
51
The Cancer Institute Hospital of JFCR
Kōtō City, Japan, 135-8550
Actively Recruiting
52
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
53
Netherlands Cancer Institute
Amsterdam, Netherlands, 1066CX
Actively Recruiting
54
Erasmus MC
Rotterdam, Netherlands, 3015GD
Actively Recruiting
55
Hospital Quiron Barcelona
Barcelona, Spain, 08023
Actively Recruiting
56
South Texas Accelerated Research Therapeutics (START) Barcelona- HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
57
Instituto Oncologico Dr Rosell (IOR)
Barcelona, Spain, 08028
Actively Recruiting
58
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
59
Hospital San Pedro
Logroño, Spain, 26006
Actively Recruiting
60
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
61
Hospital Clinico San Carlos
Madrid, Spain, 28040
Actively Recruiting
62
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Actively Recruiting
63
Hospital Universitario HM Sanchinarro
Madrid, Spain, 28050
Actively Recruiting
64
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain, 28223
Actively Recruiting
65
Hospital Universitari Sant Joan de Reus
Reus, Spain, 43204
Actively Recruiting
66
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
P
Physicians interested in becoming principal investigators please contact
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here