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

  • Recruiting
  • Treatment
  • Interventional
  • Non Randomized
  • Drug
  • PHASE1
  • Eli Lilly and Company
  • 18 Years -


Study Purpose

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.

Intervention

Drug : LY4052031


Eligibility Requirements

info icon Have one of the following solid tumor cancers: * Cohort A1: urothelial carcinoma, triple negative breast cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, ovarian cancer, cervical cancer (squamous cell carcinoma), head and neck squamous cell carcinoma or prostate cancer * Cohort A2/B1/B2: urothelial carcinoma * Cohort C: triple negative breast cancer, non-small cell lung cancer, ovarian cancer, cervical cancer, HNSCC (head and neck squamous cell carcinoma), esophageal cancer, pancreatic cancer, or prostate cancer

info icon Prior Systemic Therapy Criteria: * Cohort A1/C: Individual has received all standard therapies for which the participant was deemed to be an appropriate candidate by the treating investigator; OR there is no standard therapy available for the disease. There is no restriction on number of prior therapies * Cohort A2/B1/B2: Individual must have received at least one prior regimen in the advanced or metastatic setting. There is no restriction on number of prior therapies.

info icon 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.

info icon 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

info icon Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

info icon Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

info icon Minimum age: 18

info icon Individual with known or suspected uncontrolled CNS metastases

info icon Individual with uncontrolled hypercalcemia

info icon Individual with uncontrolled diabetes

info icon Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant

info icon Any serious unresolved toxicities from prior therapy

info icon Significant cardiovascular disease

info icon Recent thromboembolic event or bleeding disorder

info icon Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms

info icon History of pneumonitis/interstitial lung disease

info icon History of Grade ≥3 skin toxicity when receiving enfortumab vedotin

info icon Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Recruiting status

Recruiting

Estimated enrollment

420

 
Study start date

Jul 01, 2024

Study end date

May 31, 2027

Last updated

Mar 22, 2025

Primary purpose

Treatment

Design

Interventional

Intervention

Drug

Study phase

PHASE1

Allocation

Non Randomized

 

Sponsor:

Eli Lilly and Company

Collaborator:

N/A

Investigator:

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)

NCT06465069

Clinic Location Investigator Distance RECRUITING STATUS Contact