LY4050784 for Advanced Cancer

Recruiting at 21 trial 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.

Research Team

Amy Eun Chang

Principal Investigator

Eli Lilly and Company

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

Measurability of disease: Measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

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

I have tried or cannot take all standard treatments for my condition.

Exclusion Criteria

I have a history of heart rhythm problems.

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

I have previously been treated with SMARCA2/BRM inhibitors or degraders.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a - Dose Escalation

Escalating doses of LY4050784 administered orally to determine the maximum tolerated dose

Up to 48 months

Phase 1b - Dose Optimization/Expansion

Comparing 2 or more doses of LY4050784 for dose optimization and expansion

Up to 48 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY4050784 (Other)

Trial Overview 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.

Participant Groups

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

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

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

LY4050784 administered orally.

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

Escalating doses of LY4050784 administered orally.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology