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

Launched by ELI LILLY AND COMPANY · Jun 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called LY4052031 to see if it is safe and effective for patients with advanced or metastatic solid tumors, including types of bladder, breast, lung, and pancreatic cancer. The trial is divided into two parts: the first part looks at different doses of the drug to find out which is best, and the second part will test the drug on a larger group of participants. The study is expected to last up to four years, and they are currently looking for patients aged 65 and older who have specific types of cancer and have already tried standard treatments.

To be eligible for this trial, participants need to have certain types of solid tumors and should have received at least one previous treatment. They must also have a good performance status, meaning they are relatively fit and able to carry out daily activities. During the trial, participants will receive the study drug and be monitored for its effects. It’s important to know that certain health conditions or recent medical issues may prevent someone from joining the study. Overall, this trial aims to offer new hope for patients with challenging cancer diagnoses.

Gender

ALL

Eligibility criteria

• 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 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.
• * Prior enfortumab vedotin specific requirements:
• • Cohorts A1/A2/C: 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
• 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 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 ms
• • History of pneumonitis/interstitial lung disease
• • History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
• • Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention