LY4052031 for Cancer
(NEXUS-01 Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Eli Lilly and Company

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

No Placebo Group

Trial Summary

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.

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.

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.

+3 more

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.

+8 more

Trial 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

Participant Groups

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).

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).