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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last up to approximately 4 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether LY4052031 is safe, how well people handle it, and whether it works against cancer. It is for people with cancer that has grown or spread, including cancer of the urinary tract and certain other solid tumors. The study will last up to about 4 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a cancer allowed in your study group: urinary tract, triple-negative breast, non-small cell lung, esophageal (food pipe), pancreatic, ovarian, cervical, head and neck, or prostate cancer. Some groups require specific cancer types.
  • Groups A1/C: Have had all standard treatments that your doctor thinks are right for you, or have no standard treatment available.
  • Groups A2/B1/B2: Have had at least one drug treatment for advanced or spread cancer.
  • Group D: Have had no treatment for urinary tract cancer that has grown nearby or spread.
  • Prior use of the drug enfortumab vedotin depends on your group. B1 must not have used it for advanced or spread cancer; B2 must have used it. Other groups allow it but do not require it.
  • Have cancer that can be measured under study rules. Group A1 may allow cancer that cannot be measured.
  • Be fully active, or able to walk and do light work even if hard physical activity is limited.
  • Have a saved tumor sample, or have a new sample taken if local rules allow it.

Who can't join

  • Known or suspected cancer spread to the brain or spinal cord that is not controlled.
  • High blood calcium or diabetes that is not controlled.
  • Damage or swelling in the cornea (the clear front of the eye), or a past cornea transplant.
  • Serious side effects from past treatment that have not gone away; or severe skin side effects from enfortumab vedotin that required stopping it.
  • Serious heart or blood vessel disease, or a heart test showing a certain delay between beats (QTcF of 470 milliseconds or more).
  • A recent blood clot or a serious bleeding disorder.
  • A history of lung inflammation or scarring, called pneumonitis or interstitial lung disease.
  • Pregnant, breastfeeding, or planning to breastfeed during the study or within 30 days after the last study dose.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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/B/D: 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. * Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer. * Prior enfortumab vedotin specific requirements: * Cohorts A1/A2/C/D: 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 Criteria: * 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 associated with enfortumab vedotin that required treatment discontinuation * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Study sites (23)

CA

CO

FL

GA

IL

IN

MA

MI

MO

NY

OH

TN

TX

UT