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First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05768139 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Ribociclib
- DRUG STX-478
Study Locations (20)
California
- Ellison Clinic at Saint John's — Los Angeles
- UCSF Medical Center at Mission Bay — San Francisco
Florida
- Florida Cancer Specialists ORLANDO/DDU — Lake Mary
- Moffitt Cancer Center — Tampa
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Michigan
- Barbara Ann Karmanos Cancer Institute — Detroit
- START Midwest — Grand Rapids
Missouri
- Saint Luke's Cancer Institute — Kansas City
- Washington University — St Louis
Ohio
- UH Cleveland Medical Center — Cleveland
- Stefanie Spielman Comprehensive Breast Center — Columbus
Colorado
- University of Colorado Cancer Center — Aurora
Connecticut
- Yale-New Haven Hospital — New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 720 participants |
| Start Date | 2023-04-17 |
| Est. Completion | 2030-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05768139
The ClinicalTrials.gov registry entry for NCT05768139 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions — of which Letrozole is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05768139 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05768139 about?
NCT05768139 is a clinical study titled "First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors". 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 monotherap...
What is the current status of trial NCT05768139?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 720 participants. The study started on 2023-04-17. Estimated completion is 2030-07.
What conditions does trial NCT05768139 study?
This clinical trial studies the following conditions: Breast Cancer, Solid Tumors, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05768139?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Ribociclib (DRUG), STX-478 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05768139?
This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05768139 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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