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A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
Trial Status: active
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.
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/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 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
