Home › Trials › NCT06561685

Testing LY4050784 for advanced or metastatic solid tumors

An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations

Phase 1 Interventional Eli Lilly and Company · NCT06561685

This study is testing a new drug called LY4050784 to see if it can help people with advanced or metastatic solid tumors, especially those with specific gene changes, by trying it alone or with other cancer treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment340 (estimated)
Ages18 Years and up
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations33 sites (Santa Monica, California and 32 other locations)
Trial IDNCT06561685 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and effectiveness of the drug LY4050784 in patients with advanced or metastatic solid tumors, particularly those with alterations in the SMARCA4 (BRG1) gene. The study is divided into two parts: a dose-escalation phase (Phase 1a) and a dose-optimization and expansion phase (Phase 1b). Participants may receive LY4050784 alone or in combination with other anticancer agents such as Pembrolizumab, Cisplatin, Carboplatin, or Pemetrexed. The study aims to enroll patients who have previously received or are not eligible for standard treatments.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced or metastatic solid tumors exhibiting SMARCA4 (BRG1) alterations who have exhausted standard treatment options.

Not a fit: Patients with solid tumors that do not have SMARCA4 (BRG1) alterations or those who are eligible for standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited or no effective therapies.

How similar studies have performed: While this approach is novel in targeting SMARCA4 alterations, similar studies have shown promise in treating other genetic alterations in solid tumors.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have one of the following locally advanced or metastatic solid tumor malignancy with SMARCA4 (BRG1) alteration:

  * Phase 1a dose escalation: Presence of any alteration in SMARCA4 (BRG1)
  * Phase 1b expansion: Part A: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
  * Phase 1b expansion: Part B: Any tumor type (other than NSCLC) that has the presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
  * Phase 1b expansion: Part C: Non-small Cell Lung Cancer (NSCLC) that is locally advanced and not suitable for definitive locoregional therapy, or metastatic with presence of a known or likely loss of function alteration in SMARCA4 (BRG1) or loss of protein expression.
* Prior Systemic Therapy Criteria:

  * Phase 1a dose escalation and Phase 1b (Part B): Participants who received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating Investigator; or the individual is refusing the remaining most appropriate standard of care treatment; or there is no standard therapy available for the disease.
  * Phase 1b expansion (Part A): Participants must have received at least one line of therapy for advanced or metastatic disease.
  * Phase 1b expansion (Part C): Participants may be treatment naïve or have received therapy for advanced or metastatic disease
* Measurability of disease

  * Phase 1a dose escalation (excluding backfill): measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
  * Phase 1a backfill and Phase 1b expansion: Measurable disease required as defined by RECIST v1.1
* Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Exclusion Criteria:

* Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations
* Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation)
* Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
* Participants with history of increased risk of prolonged QT or significant arrythmia
* Significant cardiovascular disease
* Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolment
* Participants who are pregnant, breastfeeding or plan to breastfeed or expecting to conceive or father children during study or within 6 months after the last dose of study intervention
* Participants with history of active autoimmune diseases, history of allogenic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)

Where this trial is running

Santa Monica, California and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Solid TumorAdvanced Solid TumorNon-small Cell Lung CancerSMARCA4-Deficient TumorSMARCA2SMARCA4Lung cancerBRM
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.