First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

ClinicalTrials.gov ID: NCT05768139

Public ClinicalTrials.gov record NCT05768139. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 1:03 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05768139
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 880 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Apr 16, 2023
Primary completion: Jun 30, 2030
Completion: Jun 30, 2030
Last update posted: Jul 6, 2026

2023 – 2030

United States locations

U.S. sites: 28
U.S. states: 17
U.S. cities: 25

Facility	City	State	ZIP	Site status
Ellison Clinic at Saint John's	Los Angeles	California	90064	Recruiting
UCSF Medical Center at Mission Bay	San Francisco	California	94143	Recruiting
University of Colorado Cancer Center	Aurora	Colorado	80045	Recruiting
Yale-New Haven Hospital	New Haven	Connecticut	06510	Completed
Florida Cancer Specialists ORLANDO/DDU	Lake Mary	Florida	32746	Completed
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
Winship Cancer Institute, Emory University	Atlanta	Georgia	30322	Recruiting
University of Iowa	Iowa City	Iowa	52242	Recruiting
Louisiana State University Health Sciences Center	New Orleans	Louisiana	70112	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	02115	Recruiting
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	Recruiting
Barbara Ann Karmanos Cancer Institute	Detroit	Michigan	48201	Terminated
START Midwest	Grand Rapids	Michigan	49546	Recruiting
Saint Luke's Cancer Institute	Kansas City	Missouri	64111-3220	Recruiting
Washington University	St Louis	Missouri	63110	Recruiting
Memorial Sloan Kettering Cancer Center	New York	New York	10065	Recruiting
UH Cleveland Medical Center	Cleveland	Ohio	44106	Recruiting
Stefanie Spielman Comprehensive Breast Center	Columbus	Ohio	43212	Recruiting
Providence Cancer Institute Franz Clinic	Portland	Oregon	97213	Recruiting
The West Clinic, PLLC dba West Cancer Center	Germantown	Tennessee	38138	Recruiting
Sarah Cannon Research Institute	Nashville	Tennessee	37203	Recruiting
Mary Crowley Cancer Research Center	Dallas	Texas	75230	Completed
Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas	75246-2092	Recruiting
University of Texas Southwestern	Dallas	Texas	75390	Recruiting
University of Texas MD Anderson Cancer Center	Houston	Texas	77030	Recruiting
START San Antonio	San Antonio	Texas	78229	Recruiting
START Mountain Region	West Valley City	Utah	84119	Recruiting
USO-Virginia Cancer Specialists, PC	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05768139, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 6, 2026 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05768139 live on ClinicalTrials.gov.

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