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Trial NCT06465069

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

Phase
Phase 1
Sponsor
Eli Lilly and Company
Conditions
Metastatic Solid Tumor; Recurrent Solid Tumor; Advanced Solid Tumor; Urinary Bladder Neoplasm; Triple Negative Breast Cancer; Non-small Cell Lung Cancer; Esophageal Cancer; Pancreatic Cancer; Ovarian Cancer; Cervical Cancer; Head and Neck Squamous Cell Carcinoma; Prostate Cancer; Renal Pelvis Cancer; Bladder Cancer
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

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/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 1Performance status * 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 metastasesBrain metastases * Individual with uncontrolled hypercalcemia * Individual with uncontrolled diabetesDiabetes * Individual with evidence of corneal keratopathy or keratitis, and history of corneal transplant * Any serious unresolved toxicities from prior therapy * Significant cardiovascular disease * Recent thromboembolic event and/or clinically significant bleeding disorder * Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 msCardiac * History of pneumonitis/interstitial lung disease * History of Grade ≥3 skin toxicity associated with enfortumab vedotin that required treatment discontinuation * Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study interventionPregnancy

Restrictions found (5)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County