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LY4050784 (Phase 1a - Dose Escalation) for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months or 4 years
Awards & highlights

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.

Who is the study for?
This trial is for people with advanced or metastatic solid tumors, including non-small cell lung cancer, who have a BRG1 alteration. It's aimed at those who've had prior treatments, don't qualify for standard care, refuse it, or have no available standard therapy.
What is being tested?
The study drug LY4050784 is being tested to see if it's safe and effective in treating these types of tumors. The trial has two parts: phase Ia to find the right dose and phase Ib to confirm that dose and expand testing. It will last about 4 years.
What are the potential side effects?
Since this summary does not provide specific side effects of LY4050784, we can assume typical side effects may include nausea, fatigue, allergic reactions or other common drug-related issues observed in early-phase trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months or 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 48 months or 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Phase 1a: To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of LY4050784
Phase 1b (Dose optimization only): To confirm the RP2D/optimal dose based on safety and efficacy of LY4050784
Phase 1b: To assess the antitumor activity of LY4050784 Monotherapy: Overall response rate (ORR)
+1 more
Secondary study objectives
Phase Ia: To evaluate the preliminary antitumor activity of LY4050784: Overall response rate (ORR)
To characterize the PK properties of LY4050784: Area under the concentration versus time curve (AUC)
To characterize the PK properties of LY4050784: Time to Maximum Concentration (Tmax)
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: LY4050784 (Phase 1b - Dose Optimization/Part A)Experimental Treatment1 Intervention
Comparing 2 or more doses (evaluated during dose escalation) of LY4050784 administered orally.
Group II: LY4050784 (Phase 1b - Dose Expansion/Part B)Experimental Treatment1 Intervention
LY4050784 administered orally.
Group III: LY4050784 (Phase 1a - Dose Escalation)Experimental Treatment1 Intervention
Escalating doses of LY4050784 administered orally.

Find a Location

Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
69 Previous Clinical Trials
10,409 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,635 Previous Clinical Trials
3,222,085 Total Patients Enrolled
Amy Eun ChangStudy DirectorLoxo Oncology, Inc.
1 Previous Clinical Trials
220 Total Patients Enrolled
~107 spots leftby Oct 2027
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