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Official Title

A Phase 1 Trial Investigating LY4101174, an Antibody-Drug Conjugate Targeting Nectin-4, in Participants With Recurrent, Advanced or Metastatic Solid Tumors

Phase
Phase 1
Sponsor
Eli Lilly and Company
Enrollment
490
Timeline
Mar 2024 → Mar 2027
About This Study

The purpose of this study is to find out whether the study drug, LY4101174, is safe, tolerable and effective in participants with select advanced or metastatic solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.

Eligibility Criteria

Inclusion Criteria

  • 1Have one of the following solid tumor cancers:
  • 2Cohort 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
  • 3Cohort A2/B1/B2: urothelial carcinoma
  • 4Cohort C1: triple negative breast cancer
  • 5Cohort C2: non-small cell lung cancer
  • 6Cohort C3: ovarian or fallopian tube cancer
  • 7Cohort C4: cervical cancer
  • 8Cohort C5: head and neck squamous cell carcinoma
  • 9Prior Systemic Therapy Criteria:
  • 10Cohort 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
  • 11Cohort 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.
  • 12Prior enfortumab vedotin specific requirements:
  • 13Cohorts A1/A2/C1-5: prior treatment with enfortumab vedotin is allowed, but not required
  • 14Cohort B1: individual must be enfortumab vedotin naive in the advanced/metastatic setting
  • 15Cohort B2: individual must have received enfortumab vedotin in the metastatic/advanced setting.
  • 16Measurability of disease
  • 17Cohort A1: measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors v1.1 (RECIST 1.1)
  • 18Cohorts A2, B1, B2, C1-5: measurable disease required as defined by RECIST v1.1
  • 19Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • 20Have adequate archival tumor tissue sample available or undergo a screening biopsy if allowed per country specific regulations

Exclusion Criteria

  • 1Individual with known or suspected uncontrolled CNS metastases
  • 2Individual with uncontrolled hypercalcemia
  • 3Individual with uncontrolled diabetes
  • 4Individual with evidence of corneal keratopathy or history of corneal transplant
  • 5Any serious unresolved toxicities from prior therapy
  • 6Significant cardiovascular disease
  • 7Current of history of intestinal obstruction in the previous 3 months
  • 8Recent thromboembolic event and/or clinically significant bleeding
  • 9Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 ms
  • 10History of pneumonitis/interstitial lung disease
  • 11History of Grade ≥3 skin toxicity when receiving enfortumab vedotin
  • 12Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
  • 13Individual with active uncontrolled infection

Locations

28 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

AdventHealth Orlando

Orlando, Florida 32804

Recruiting

Massachusetts General Hospital

Boston, Massachusetts 02114

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →