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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
Nectin-4 Antibody-Drug Conjugate 2
LY4052031
Phase
1
Enrolling

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†

Related Resources:
Molecule Overview Trial Enrollment
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Key Inclusion Criteria
  • Prior systemic therapy criteria:
    • Cohorts A1 and C1: Participant 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
    • Cohorts A2, B1, and B2: Participant 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, and C1: Prior treatment with enfortumab vedotin is allowed, but not required
    • Cohort B1: Participant must be enfortumab vedotin naïve in the advanced/metastatic setting
    • Cohort B2: Participant must have received enfortumab vedotin in the metastatic/advanced setting
  • Measurability of disease
    • Cohort A1: Measurable or nonmeasurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
    • Cohorts A2, B1, B2, and C1: Measurable disease required as defined by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate archival tumor tissue sample available or undergo a screening biopsy if deemed safe and allowed per country-specific regulations
Key Exclusion Criteria
  • Known or suspected uncontrolled central nervous system metastases
  • Uncontrolled hypercalcemia
  • Uncontrolled diabetes
  • Evidence of corneal keratopathy or keratitis, and history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Current or prior intestinal obstruction in the previous 3 months
  • Recent thromboembolic event or bleeding disorder
  • Prolongation of the 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
  • Pregnant, breastfeeding, or plan to breastfeed during study or within 30 days of last dose of study intervention
*
LY4052031 is administered intravenously as monotherapy.
†
This clinical trial is being conducted globally.
‡
One of the following solid tumor cancers: 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.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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or visit www.clinicaltrials.gov for more information on this trial