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Monoclonal Antibodies
LY4052031 for Cancer (NEXUS-01 Trial)
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 of 0 or 1
Measurability of disease: Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1). Cohorts A2, B1, B2, C: measurable disease required as defined by RECIST v1.1
Must not have
Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
Individual with uncontrolled diabetes
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 LY4052031 is safe and effective in treating advanced solid tumors, such as urothelial cancer. The study is divided into two parts - phase I
Who is the study for?
This trial is for people with advanced or metastatic solid tumors, including urothelial cancer and various other cancers like lung, breast, esophageal, and more. Participants should have a tumor that's progressed after treatment or be untreatable with standard therapies.
What is being tested?
The study tests LY4052031 to see if it's safe and works against different types of advanced cancers. It has two parts: first finding the right dose (phase Ia) and then seeing how well it works at that dose (phase Ib).
What are the potential side effects?
Possible side effects of LY4052031 are not specified but may include typical reactions to cancer drugs such as nausea, fatigue, allergic reactions, or issues related to the specific mechanism of action of the drug.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or have some restrictions but can still carry out light work.
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My cancer can be measured using specific criteria.
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I have one of the listed types of cancer.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had issues with my cornea and a corneal transplant.
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My diabetes is not under control.
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I have a serious heart condition.
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I have had a recent clotting event or bleeding problem.
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I have had lung inflammation or scarring before.
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I might have untreated cancer spread to my brain.
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I don't have ongoing serious side effects from past treatments.
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I have high calcium levels in my blood that aren't managed.
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I have experienced severe skin reactions from enfortumab vedotin treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 48 months or 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 48 months or 4 years
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 recommended phase 2 dose (RP2D) or optimal dose of LY4052031
Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)
Secondary study objectives
To characterize the PK properties of LY4052031: Area under the concentration versus time curve (AUC)
To characterize the pharmacokinetics (PK) properties of LY4052031: Minimum Plasma Concentration (Cmin)
To evaluate the preliminary antitumor activity of LY4052031: Disease control rate (DCR)
+5 moreAwards & 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: LY4052031 (Dose-optimization, Cohort A2)Experimental Treatment1 Intervention
Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.
Group II: LY4052031 (Dose-expansion, Cohort B1, B2, C1)Experimental Treatment1 Intervention
LY4052031 administered IV.
Group III: LY4052031 (Dose-escalation, Cohort A1)Experimental Treatment1 Intervention
Escalating doses of LY4052031 administered intravenously (IV).
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,164 Total Patients Enrolled
65 Trials studying Breast Cancer
36,728 Patients Enrolled for Breast Cancer
Loxo Oncology, Inc.Industry Sponsor
71 Previous Clinical Trials
10,840 Total Patients Enrolled
2 Trials studying Breast Cancer
193 Patients Enrolled for Breast Cancer
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,621 Total Patients Enrolled
22 Trials studying Breast Cancer
10,804 Patients Enrolled for Breast Cancer
Amy Eun ChangStudy DirectorLoxo Oncology, Inc.
1 Previous Clinical Trials
160 Total Patients Enrolled