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NCT05768139 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of STX-478 as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
A Phase 1 study of Breast Cancer and Solid Tumors, Adult, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 720
- Enrollment target
- 20
- Study locations
NCT05768139: Recruiting Phase 1 study of Breast Cancer and Solid Tumors, Adult, sponsored by Eli Lilly and Company.
NCT05768139 is a Phase 1 study of Breast Cancer and Solid Tumors, Adult that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 720 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05768139, a Phase 1 study of Breast Cancer and Solid Tumors, Adult, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 720 participants
- Enrollment target
- 20
- Study locations
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 |
What NCT05768139 shows while recruiting
NCT05768139 is an interventional study that assigns participants to a tested intervention. The registered 720 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (74% lower).
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.
NCT05768139 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
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.
What interventions are being tested in trial NCT05768139?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Ribociclib (DRUG), STX-478 (DRUG).
Who is sponsoring clinical trial NCT05768139?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05768139's enrollment target sits among peer trials
720 157th of 1224 higher than 1,067 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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