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

Launched by ELI LILLY AND COMPANY · Jan 26, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new drug called LY4101174 to see if it is safe and effective for people with advanced solid tumors that have come back or spread to other parts of the body. The trial is divided into two parts: one where different doses of the drug are tested to find the best amount (called dose-escalation), and another part where more people will receive this dose to further assess its effectiveness. The study is open for participation and will continue for about four years.

To be eligible for this trial, participants should have specific types of advanced cancers, such as bladder, breast, lung, pancreatic, ovarian, cervical, head and neck, prostate, or renal cancers, and they should have received previous treatments. Participants will need to have measurable disease (meaning the cancer can be seen and tracked), and they should be in good overall health. Throughout the trial, participants will receive the study drug and be monitored closely for side effects and how well the drug works. It's important to note that individuals with certain health issues, such as uncontrolled brain metastases or serious heart problems, cannot participate.

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 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
• 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 history of corneal transplant
• • Any serious unresolved toxicities from prior therapy
• • Significant cardiovascular disease
• • Current of history of intestinal obstruction in the previous 3 months
• • Recent thromboembolic event and/or clinically significant bleeding
• • 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
• • Individual with active uncontrolled infection