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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 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.

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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

Breast Cancer Solid Tumors, Adult

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

FieldValue
Enrollment Target 720 participants
Start Date 2023-04-17
Est. Completion 2030-07
Phase Phase 1

Sponsor

Eli Lilly and Company

1,341 total trials

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What the Registry Record Tells You About NCT05768139

The ClinicalTrials.gov registry entry for NCT05768139 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 720 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (74% lower). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.