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
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)
- Brain metastasesConditionalexclusionShow in the text
- CardiacOutrightexclusion
QTcF >= 470 ms
Show in the text - DiabetesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG 0 or 1
Show in the text - PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County