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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

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 below

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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:

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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

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 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 more

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).

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,640 Previous Clinical Trials

3,221,424 Total Patients Enrolled

Loxo Oncology, Inc.Industry Sponsor

69 Previous Clinical Trials

10,082 Total Patients Enrolled

Amy Eun ChangStudy DirectorLoxo Oncology, Inc.

1 Previous Clinical Trials

160 Total Patients Enrolled

~147 spots leftby May 2027

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