LY4050784 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+21 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

Must not be taking: SMARCA2 inhibitors

Disqualifiers: SMARCA2 alterations, CNS involvement, cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants with locally advanced or metastatic solid tumors with a BRG1 (Brahma-related gene 1, also known as SMARCA4) alteration who have previously received, do not qualify for, or are refusing standard of care treatments, or there is no standard therapy available for the disease. The study is conducted in two parts - phase Ia (dose-escalation) and phase Ib (dose-optimization, dose-expansion). The study will last up to approximately 4 years.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Eligibility Criteria

This trial is for people with advanced or metastatic solid tumors, including non-small cell lung cancer, who have a BRG1 alteration. It's aimed at those who've had prior treatments, don't qualify for standard care, refuse it, or have no available standard therapy.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My cancer has a BRG1/SMARCA4 genetic change.

Exclusion Criteria

I have a history of heart rhythm problems.

I am not pregnant, breastfeeding, planning to conceive, or father a child during the study or within 6 months after it ends.

My cancer is linked to a specific genetic change in SMARCA2/BRM.

I have untreated or uncontrolled brain involvement.

I have a serious heart condition.

Participant Groups

The study drug LY4050784 is being tested to see if it's safe and effective in treating these types of tumors. The trial has two parts: phase Ia to find the right dose and phase Ib to confirm that dose and expand testing. It will last about 4 years.

3Treatment groups

Experimental Treatment

Group I: LY4050784 (Phase 1b - Dose Optimization/Part A)Experimental Treatment1 Intervention

Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.

Group II: LY4050784 (Phase 1b - Dose Expansion/Part B)Experimental Treatment1 Intervention

LY4050784 administered orally.

Group III: LY4050784 (Phase 1a - Dose Escalation)Experimental Treatment1 Intervention

Escalating doses of LY4050784 administered orally.