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PIPELINE > TRIAL OVERVIEW

NCT06400472

Breast Cancer | NSCLC | Cervical Cancer | Colorectal Cancer | Endometrial Cancer | Ovarian Cancer | Pancreatic Cancer | Triple-Negative Breast Cancer

Trial Information
Molecule Overview
FRα Antibody-Drug Conjugate
LY4170156
Phase
1
Recruiting
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4170156, an Antibody-Drug Conjugate Targeting Folate Receptor α-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumorsa
Related Resources:
Molecule Overview Trial Enrollment
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Key Inclusion Criteria
  • Participants aged ≥18 years with historic diagnosis of locally advanced or metastatic solid tumor malignancy as defined below for each cohort:
    • Cohort A1 (dose escalation): Histological diagnosis of ovarian cancer (includes epithelial ovarian, primary peritoneal, and fallopian tube), endometrial cancer, cervical cancer, non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), pancreatic cancer, or colorectal cancer (CRC)
    • Cohort A2 (dose optimization), Cohorts B1 and B2 (dose expansion): Histological diagnosis of ovarian cancer (includes epithelial ovarian, primary peritoneal, and fallopian tube) that is resistant to prior platinum treatment (defined as recurrence or progression within 6 months of last platinum dose). Individuals with platinum-refractory disease (progression on front-line platinum-based chemotherapy or within 3 months of completing front-line treatment) are not eligible
    • Cohorts C1 and C2 (dose expansion): Histological or cytological diagnosis of endometrial cancer, cervical cancer, NSCLC, TNBC, pancreatic cancer, or CRC
Key Exclusion Criteria
  • Known or suspected uncontrolled central nervous system (CNS) metastases
  • History of carcinomatous meningitis
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Evidence of corneal keratopathy or history of corneal transplant
  • Any serious unresolved toxicities from prior therapy
  • Significant cardiovascular disease
  • Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) >470 milliseconds (ms)
  • History of pneumonitis/interstitial lung disease
  • Individuals who are pregnant, breastfeeding, or plan to breastfeed during study or within 30 days of last dose of study intervention
a
This clinical trial is being conducted globally.
b
Administered intravenously.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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