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A Study of LY4052031 for Advanced Solid Tumors

This study is testing a drug called LY4052031 for people with advanced or metastatic (spread to other parts of the body) solid tumors, including urothelial cancer (bladder cancer) and triple-negative breast cancer. LY4052031 is an antibody-drug conjugate, which means it's designed to deliver medicine directly to cancer cells that have a specific protein called nectin-4. The main goals are to find a safe and effective dose of LY4052031 and to see how well it shrinks tumors. The study is currently recruiting and plans to enroll up to 420 participants aged 18 and older. You may be eligible if you have certain types of solid tumors, such as urothelial carcinoma or triple-negative breast cancer.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It has two parts: Phase 1a to find the right dose, and Phase 1b to see how well the drug works.
What's involved
The study will last up to approximately 4 years. The primary endpoint for dose finding is measured at Cycle 1 (21 Days), and for anti-tumor activity, it's measured for up to approximately 48 months or 4 years.
Compensation
Not stated in the trial record.
Follow-up
The study will assess anti-tumor activity for up to approximately 48 months or 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06465069

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eli Lilly and Company
~420 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:LY4052031

At a glance

Recruiting sites
35 of 39 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031
Measured over Cycle 1 (21 Days)
+1 more outcome measured

Conditions

Metastatic Solid Tumor
Recurrent Solid Tumor
Advanced Solid Tumor
Urinary Bladder Neoplasm
Triple Negative Breast Cancer
Non-small Cell Lung Cancer
Esophageal Cancer
Pancreatic Cancer
Ovarian Cancer
Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Prostate Cancer
Renal Pelvis Cancer
Bladder Cancer

Explore related trials

Cervical CarcinomaEsophageal CarcinomaHead and Neck Squamous Cell CarcinomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmPancreatic CarcinomaProstate CarcinomaSolid NeoplasmTriple-negative breast cancerUrothelial Carcinoma

Where it's being run

39 sites across 20 states
New York5
Japan4
Spain4
California3
China3
Tennessee2
Texas2
Utah2

Study leadership

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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.
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.
Measurability of disease
Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
Measurable disease is required as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1) for all Cohorts. Cohort A1 may permit non-measurable disease as defined by RECIST v1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion

Individual with known or suspected uncontrolled CNS metastases
Individual with uncontrolled hypercalcemia
Individual with uncontrolled diabetes
Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Recent thromboembolic event and/or clinically significant bleeding disorder
Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
History of pneumonitis/interstitial lung disease
History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

What this trial measures

  • Phase 1a: To determine the recommended phase 2 dose (RP2D) optimal dose(s) of LY4052031Cycle 1 (21 Days)

    Number of participants with dose-limiting toxicities (DLTs)

  • Phase 1b: To assess the antitumor activity of LY4052031 Monotherapy: Overall response rate (ORR)Up to Approximately 48 Months or 4 Years

    ORR per investigator assessed Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)