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OncoMatch/Clinical Trials/NCT06465069

A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Official title: A Phase 1a/1b Study of LY4052031, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Advanced or Metastatic Urothelial Carcinoma or Other Solid Tumors

Is NCT06465069 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including LY4052031 and Pembrolizumab for metastatic solid tumor.

Phase 1RecruitingEli Lilly and CompanyNCT06465069Data as of Oct 2026Location: International · 8 countries

Treatment: LY4052031 · Pembrolizumab — 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Pembrolizumab

Other

LY4052031

Cancer type

Tumor Agnostic

Urothelial Carcinoma

Triple-Negative Breast Cancer

Breast Carcinoma

Non-Small Cell Lung Carcinoma

Esophageal Carcinoma

Pancreatic Cancer

Ovarian Cancer

Cervical Cancer

Head and Neck Squamous Cell Carcinoma

Prostate Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: enfortumab vedotin

Exception: history of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation

History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation

Lab requirements

Cardiac function

Significant cardiovascular disease; QTcF ≥ 470 ms

Significant cardiovascular disease; Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • City of Hope National Medical Center · Duarte, California
  • University of California, San Diego (UCSD) - Moores Cancer Center · La Jolla, California
  • UCLA Department of Medicine-Hematology/Oncology · Los Angeles, California
  • Sarah Cannon Research Institute at HealthOne · Denver, Colorado
  • Florida Cancer Specialists and Research Institute · St. Petersburg, Florida

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06465069 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior enfortumab vedotin disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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