LY4050784 for Advanced Cancer
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1a - Dose Escalation
Escalating doses of LY4050784 administered orally to determine the maximum tolerated dose
Phase 1b - Dose Optimization/Expansion
Comparing 2 or more doses of LY4050784 for dose optimization and expansion
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
6
Treatment groups
Experimental Treatment
Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
LY4050784 administered orally in combination in combination with pembrolizumab, paclitaxel/nab-paclitaxel and carboplatin administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY4050784 administered orally in combination in combination with pembrolizumab, pemetrexed, and platinum (cisplatin or carboplatin) administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY4050784 administered orally in combination in combination with pembrolizumab administered IV in 21-day cycles. Participants may continue to receive treatment until discontinuation criteria are met.
LY4050784 administered orally.
Escalating doses of LY4050784 administered orally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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
1.
ir.foghorntx.com
ir.foghorntx.com/news-releases/news-release-details/foghorn-therapeutics-provides-third-quarter-2025-financial-andFoghorn 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.
4.
globenewswire.com
globenewswire.com/news-release/2025/11/05/3181279/0/en/Foghorn-Therapeutics-Provides-Third-Quarter-2025-Financial-and-Corporate-Update.htmlFoghorn Therapeutics Provides Third Quarter 2025 Financial
Ongoing FHD-909 (LY4050784) Phase 1 dose escalation trial in SMARCA4 (BRG1)-mutated cancer remains on track with non-small cell lung cancer ...
5.
ir.foghorntx.com
ir.foghorntx.com/news-releases/news-release-details/foghorn-therapeutics-presents-new-preclinical-data-selectiveRelease Details
FHD-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.
7.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_1/3779/755917/Abstract-3779-LY4050784-a-selective-inhibitor-ofAbstract 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 ...
9.
lillyoncologypipeline.com
lillyoncologypipeline.com/flashcards/SMARCA2_Flashcard_Aug_2025_v1.00.pdfLY4050784
The 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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