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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 Tumorsa

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
a
This clinical trial is being conducted globally.
b
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.
c
Administered intravenously as monotherapy.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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