A Study of LY4052031 in Participants With Advanced or Metastatic Urothelial Cancer or Other Solid Tumors

Korábbi kezelés

• Any serious unresolved toxicities from prior therapy

Más betegség

• Individual with uncontrolled diabetes
• Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant
• Significant cardiovascular disease
• Recent thromboembolic event and/or clinically significant bleeding disorder
• History of pneumonitis/interstitial lung disease
• History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation

Laborértékek

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

Egyéb

• 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/B/D: 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.
  • Cohort D: Treatment-naive for locally advanced or metastatic urothelial cancer.
• Prior enfortumab vedotin specific requirements:
  • Cohorts A1/A2/C/D: 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