A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

Trial Title: A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors

NCT ID: NCT06561685

Condition: Metastatic Solid Tumor
Advanced Solid Tumor
Non-small Cell Lung Cancer
SMARCA4-Deficient Tumor

Conditions: Official terms:
Neoplasms

Conditions: Keywords:
SMARCA2
SMARCA4
Lung cancer
BRM
BRG1
Adenocarcinoma
Squamous cell carcinoma
Targeted therapy

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: LY4050784
Description: Oral
Arm group label: LY4050784 (Phase 1a - Dose Escalation)
Arm group label: LY4050784 (Phase 1b - Dose Expansion/Part B)
Arm group label: LY4050784 (Phase 1b - Dose Optimization/Part A)

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.

Criteria for eligibility:
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. - 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. - 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 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 or recently treated (within 2 years) second primary malignancy and/or treated for an additional 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: USO-Virginia Cancer Specialists, PC

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Start date: September 19, 2024

Completion date: October 2027

Lead sponsor:
Agency: Eli Lilly and Company
Agency class: Industry

Source: Eli Lilly and Company

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06561685
https://trials.lilly.com/en-US/trial/528616