Tests LY4050784 in adults with advanced solid tumors carrying SMARCA4 changes
Tests LY4050784, alone or with other cancer drugs, in adults with SMARCA4 tumors.
Plain-language title generated from the registry record
Registry title: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
Key facts
- Where
- Berlin, Essen, and Frankfurt am Main, GermanySee the 3 sites
- Phase
- Phase 1
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNo longer taking part
- Universitaetsklinikum Essen (AoR)Essen, GermanyNo longer taking part
- Krankenhaus Nordwest GmbHFrankfurt am Main, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Eli Lilly and Company
- Trial code
- NCT06561685EU 2024-519727-18-00
- Record updated
- 10 November 2026
- Original description
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, 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.Read full original descriptionShow less
An Open-label, Multicenter Study of LY4050784, a Selective SMARCA2/BRM Inhibitor, in Advanced Solid Tumor Malignancies With SMARCA4/BRG1 Alterations
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants alone or in combination with other anticancer agents. In addition, 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.
Inclusion: 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: Prior exposure to SMARCA2 (BRM) inhibitor(s) and/or degrader(s) (prior exposure may be permitted for dose escalation); Participants with active and/or treated for an additional primary malignancy within 2 years prior to enrolment; Participants with known or likely loss of function alteration of SMARCA2 (BRM) or malignancy with known association with SMARCA2 (BRM) alterations; Participants with known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement; Significant cardiovascular disease; 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); Participants with history of increased risk of prolonged QT or significant arrythmia; 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.