340 Participants Needed

LY4050784 for Advanced Cancer

Recruiting at 26 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY4050784, to determine its safety and effectiveness for treating certain advanced cancers. It targets cancers with changes in the SMARCA4 gene, such as some lung cancers. The study includes different parts to identify the best dose and evaluate how the drug works alone or with other cancer treatments. Individuals with advanced cancer involving SMARCA4 changes, who have tried other treatments or lack other options, might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that LY4050784 is likely to be safe for humans?

In a previous study, LY4050784, when used alone, was generally safe for people with advanced cancer. Researchers tested different doses to assess tolerance levels. The study found no major safety issues, but this remains early research.

For LY4050784 combined with pembrolizumab, early studies showed they worked well together without unexpected side effects. Pembrolizumab is already approved for some cancers, increasing researchers' confidence in its safety.

When LY4050784 was combined with pembrolizumab, pemetrexed, and platinum, past studies of these other drugs demonstrated their safety together. This suggests that adding LY4050784 may not cause major problems.

Lastly, adding LY4050784 to pembrolizumab, paclitaxel/nab-paclitaxel, and carboplatin appears promising. Past research on these drugs showed safety for people with certain lung cancers, making the addition of LY4050784 a hopeful step.

Overall, while these studies are still early, they provide some safety signals for LY4050784 alone and in combinations. However, more research is needed to confirm these findings.12345

Why do researchers think this study treatment might be promising for advanced cancer?

Researchers are excited about LY4050784 because it offers a fresh approach to treating advanced cancer. Unlike standard treatments that often target cancer cells broadly, LY4050784 is being tested for its potential to be combined with pembrolizumab, an immunotherapy drug. This combination could enhance the immune system's ability to fight cancer more effectively. The various arms of the trial explore how LY4050784 works alone and in combination with other chemotherapy agents, like pemetrexed and platinum-based drugs, potentially offering more tailored and effective treatment options for patients. This innovative approach might provide new hope for those who have not responded well to existing therapies.

What evidence suggests that LY4050784 might be an effective treatment for advanced cancer?

Research shows that LY4050784, a pill, targets specific changes in some cancer cells by blocking a protein called SMARCA2, which can help slow or stop cancer cell growth. This trial includes several treatment arms to evaluate LY4050784. One arm uses LY4050784 alone, while others combine it with pembrolizumab, a drug that boosts the immune system and shows promising effects against tumors. Additional arms explore combining LY4050784 with standard chemotherapy drugs like pemetrexed and platinum, which may enhance its effectiveness. Early lab studies demonstrated its potential effectiveness when combined with these treatments.36789

Who Is on the Research Team?

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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)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 4 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • LY4050784
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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: LY4050784 (Phase 1b - Dose Optimization/Part A)Experimental Treatment1 Intervention
Group II: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2bExperimental Treatment5 Interventions
Group III: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C2aExperimental Treatment5 Interventions
Group IV: LY4050784 (Phase 1b - Dose Expansion/Part C) Cohort C1Experimental Treatment2 Interventions
Group V: LY4050784 (Phase 1b - Dose Expansion/Part B)Experimental Treatment1 Intervention
Group VI: LY4050784 (Phase 1a - Dose Escalation)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

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

Citations

Foghorn Therapeutics Provides Third Quarter 2025 ...Ongoing FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1)-mutated cancer remains on track with non-small cell lung cancer ...
A Study of LY4050784 in Participants With Advanced ...A first-in-human phase 1 study of LY4050784, an oral, potent, and selective SMARCA2 inhibitor, in patients with advanced solid tumors with SMARCA4 alterations.
Foghorn Therapeutics Provides Second Quarter 2025 ...The primary target population is NSCLC. Synergistic preclinical data of FHD-909 in combination with pembrolizumab and KRAS inhibitors.
Foghorn Therapeutics Provides Third Quarter 2025 FinancialOngoing FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1)-mutated cancer remains on track with non-small cell lung cancer ...
Release DetailsFHD-909 (LY4050784) advancing in Phase 1 trial in SMARCA4 (BRG1) mutated cancers, with non-small cell lung cancer (NSCLC) as the primary ...
A first-in-human phase 1 study of LY4050784, an oral, ...▫ Have a locally advanced or metastatic cancer and measurable or non-measurable disease (phase 1a dose escalation only) per RECIST v1.1.
Abstract 3779: LY4050784, a selective inhibitor of SMARCA2 ...LY4050784, a selective inhibitor of SMARCA2, demonstrates synergistic activity in combinations with pembrolizumab or KRAS inhibitors.
An Open-Label, Multicenter Study of LY4050784, a Selective ...The purpose of this study is to test the safety of an investigational treatment called LY4050784 in subjects with solid tumors that have a particular ...
LY4050784The safety and efficacy of the agents for uses under investigation have not been established. Pipeline molecules may not receive regulatory approval and ...
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