A Study of LY4101174 in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Prior treatment

• Any serious unresolved toxicities from prior therapy
• Current of history of intestinal obstruction in the previous 3 months
• History of Grade ≥3 skin toxicity when receiving enfortumab vedotin

Other illness

• Individual with uncontrolled diabetes
• Individual with evidence of corneal keratopathy or history of corneal transplant
• Significant cardiovascular disease
• Recent thromboembolic event and/or clinically significant bleeding
• History of pneumonitis/interstitial lung disease
• Individual with active uncontrolled infection

Lab values

• Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms

Other

• Individual with known or suspected uncontrolled CNS metastases
• Individual with uncontrolled hypercalcemia
• Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

• 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