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A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors
Trial Status: active
The purpose of this study is to find out whether the study drug, LY4101174, is safe,
tolerable and effective in participants with select advanced or metastatic solid tumors.
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 C1: triple negative breast cancer
Cohort C2: non-small cell lung cancer
Cohort C3: ovarian or fallopian tube cancer
Cohort C4: cervical cancer
Cohort C5: head and neck squamous cell carcinoma
Prior Systemic Therapy Criteria:
Cohort A1/C1-5: 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/C1-5: 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)
Cohorts A2, B1, B2, C1-5: measurable disease required 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 history of corneal transplant
Any serious unresolved toxicities from prior therapy
Significant cardiovascular disease
Current of history of intestinal obstruction in the previous 3 months
