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LY4050784 for Advanced Cancer

Phase 1
Recruiting
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
Have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Have one of the following locally advanced or metastatic solid tumor malignancy with BRG1/SMARCA4 alteration
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 48 months or 4 years
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to determine if the drug LY4050784 is safe and effective for people with advanced solid tumors that have a specific genetic alteration. Participants in the trial have either tried standard treatments that didn

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
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer has a BRG1/SMARCA4 genetic change.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of heart rhythm problems.
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I am not pregnant, breastfeeding, planning to conceive, or father a child during the study or within 6 months after it ends.
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My cancer is linked to a specific genetic change in SMARCA2/BRM.
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I have untreated or uncontrolled brain involvement.
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I have a serious heart condition.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

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Who is running the clinical trial?

Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,900 Total Patients Enrolled
Eli Lilly and CompanyLead Sponsor
2,677 Previous Clinical Trials
3,465,471 Total Patients Enrolled
3 Trials studying Tumors
1,585 Patients Enrolled for Tumors
Amy Eun ChangStudy DirectorEli Lilly and Company
1 Previous Clinical Trials
220 Total Patients Enrolled
~107 spots leftby Oct 2027
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