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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
SMARCA2 (BRM) Inhibitor
LY4050784
Phase
1
Recruiting
An Open-Label, Multicenter Study of LY4050784, a Selective SMARCA2 (BRM) Inhibitor, in Advanced Solid Tumor Malignancies with SMARCA4 (BRG1) Alterationsa
Related Resources:
Molecule Overview Trial Enrollment
NCT06561685
Key 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): 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 nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors (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
Key Exclusion Criteria
  • Participants with known 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 enrollment
  • 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 allogeneic stem cell/organ transplant or compromised immune system within past 2 years (Part C only)
a
This clinical trial is being conducted in the United States and Japan.
b
Each dose level will enroll 3-6 DLT-evaluable patients. 
c
Administered orally.
d
Prior platinum doublet, immunotherapy, and antibody-drug conjugate therapy allowed. Sponsor may initiate a randomized dose optimization cohort within Phase 1b across 2 or more dose levels.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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