LY4052031 for Cancer

(NEXUS-01 Trial)

Recruiting at 31 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Uncontrolled CNS metastases, Hypercalcemia, Diabetes, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

420 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the purpose of this trial?

The purpose of this study is to find out whether the study drug, LY4052031, is safe, tolerable and effective in participants with advanced, or metastatic solid tumors including urothelial cancer. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

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.

Inclusion Criteria

I am fully active or have some restrictions but can still carry out light work.

Prior enfortumab vedotin specific requirements: Cohorts A1/A2/C: prior treatment with enfortumab vedotin is allowed, but not required. Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting. Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.

I have one of the listed types of cancer.

Exclusion Criteria

I have had issues with my cornea and a corneal transplant.

My diabetes is not under control.

I have a serious heart condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation and Dose Optimization (Phase 1a)

Participants receive escalating doses of LY4052031 to assess safety, tolerability, and pharmacokinetics, and determine the recommended phase 2 dose

21 days per cycle

Multiple visits per cycle (in-person)

Dose Expansion (Phase 1b)

Participants receive LY4052031 at the recommended phase 2 dose to evaluate efficacy and safety in expansion cohorts

Up to 48 months

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY4052031

Trial Overview 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).

Participant Groups

Group I: LY4052031 (Dose-optimization, Cohort A2) Experimental Treatment 1 Intervention

Comparing 2 or more doses (evaluated during dose escalation) of LY4052031 administered IV.

Group II: LY4052031 (Dose-expansion, Cohort B1, B2, C1) Experimental Treatment 1 Intervention

LY4052031 administered IV.

Group III: LY4052031 (Dose-escalation, Cohort A1) Experimental Treatment 1 Intervention

Escalating doses of LY4052031 administered intravenously (IV).

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Loxo Oncology, Inc.

Industry Sponsor

Trials

72

Recruited

11,600+

Jacob Van Naarden

Loxo Oncology, Inc.

Chief Executive Officer since 2019

A.B. in Molecular Biology from Princeton University

Dr. Jennifer Low

Loxo Oncology, Inc.

Chief Medical Officer since 2014

MD and PhD from Georgetown University; Undergraduate degree from California Institute of Technology