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

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, 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

• Breast Cancer
• Solid Tumors, Adult

Interventions

DRUG

STX-478

STX-478 is a mutant-selective PI3Kα inhibitor

DRUG

Fulvestrant

Fulvestrant

DRUG

Ribociclib

Ribociclib

DRUG

Palbociclib

Palbociclib

DRUG

Letrozole

Letrozole

DRUG

Anastrozole

Anastrozole

DRUG

Exemestane

Exemestane

DRUG

Tamoxifen

Tamoxifen

DRUG

Abemaciclib

Abemaciclib

DRUG

Imlunestrant

Imlunestrant

DRUG

Metformin

Metformin

Sponsors & Collaborators

• Eli Lilly and Company

  lead INDUSTRY

Principal Investigators

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2030-07-31

Completion

2030-07-31

FDA Drug

Yes

Countries

• United States
• Belgium
• France
• Germany
• Ireland
• Italy
• Japan
• Netherlands
• Spain

Study Locations