A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
NCT Number: NCT06561685
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Solid Tumor|Advanced Solid Tumor|Non-small Cell Lung Cancer|SMARCA4-Deficient Tumor
Interventions: DRUG: LY4050784
Sponsor: Eli Lilly and Company
Collaborators: Loxo Oncology, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 160
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2027-10
Locations: USO-Virginia Cancer Specialists, PC, Fairfax, Virginia, 22031, United States

Summary:
The main purpose of this study is to find out whether the study drug, LY4050784, is safe, tolerable and effective in participants 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.

Primary Outcome Measures: Phase Ia: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs), A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, Up to Approximately 48 Months or 4 Years|Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784, Number of participants with dose-limiting toxicities (DLTs), Up to Approximately 48 Months or 4 Years|Phase 1b: To assess the antitumor activity of LY4050784 Monotherapy: Overall response rate (ORR), ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), Up to Approximately 48 Months or 4 Years|Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784, A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module, ORR and Duration of Response (DOR) per Investigator, Up to Approximately 48 Months or 4 Years
Secondary Outcome Measures: To characterize the pharmacokinetics (PK) properties of LY4050784: Maximum Concentration (Cmax), PK: Cmax of LY4050784, Cycle 1 (Day 8)|To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax), PK: Tmax of LY4050784, Cycle 1 (Day 8)|To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC), PK: AUC of LY4050784, Cycle 1 (Day 8)|Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: Overall response rate (ORR), ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4050784: Duration of response (DOR), DOR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4050784: Time to response (TTR), TTR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4050784: Disease control rate (DCR), DCR per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years|To evaluate the preliminary antitumor activity of LY4050784: Progression free survival (PFS), PFS per investigator assessed RECIST 1.1, Up to Approximately 48 Months or 4 Years