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

Study testing Tersolisib alone and with other drugs for advanced tumors.

Recruiting
18 years and older
All
Phase 1/2

This study is testing a new medicine called Tersolisib (STX-478) for people with advanced solid tumors, which are cancers that have spread or can't be removed by surgery. The study has three parts:

  • Part 1: Tests Tersolisib alone to see if it's safe and how well it works.
  • Part 2: Combines Tersolisib with another drug called Fulvestrant for certain breast cancer patients.
  • Part 3: Combines Tersolisib with different hormone and cancer treatments for breast cancer.

To join, you must be 18 or older, have a specific cancer type, and meet health criteria. The study starts with a 28-day check-up period before treatment begins. The goal is to check the safety and effectiveness of the treatments.

  • Duration: Includes a 28-day screening period before starting treatments.
  • Eligibility: Must have advanced cancer with a specific mutation and meet health standards.
  • Risks: Cannot join if recent cancer treatments haven't resolved side effects to a safe level.
Study details
    Breast Cancer
    Solid Tumors
    Adult

NCT05768139

Eli Lilly and Company

12 September 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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