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PIPELINE > TRIAL OVERVIEW

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, in Participants With Selected Advanced Solid Tumorsa
Related Resources:
Molecule Overview Trial Enrollment
NCT06400472 show modal icon
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): Ovarian cancer,c endometrial cancer, cervical cancer, NSCLC, TNBC, pancreatic cancer, or CRC
    • Cohort A2 (dose optimization), Cohorts B1 and B2 (dose expansion): Ovarian cancerc that is resistant to prior platinum treatment.d Individuals with platinum-refractory diseasee are not eligible
    • Cohort A3: Ovarian cancerc with high FRα expression (≥75% at ≥2+ intensity), no prior treatment with mirvetuximab soravtansine, and resistant to prior platinum treatment
    • Cohort A4 (combination cohort with bevacizumab): Ovarian cancerc sensitive to prior platinum treatment
    • Cohort A5 (dose escalation combination with carboplatin): Ovarian cancerc that is sensitive to prior platinum treatmentf
    • Cohorts C1 and C2 (dose expansion): 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
  • Any serious unresolved toxicities from prior therapy
  • History of pneumonitis/interstitial lung disease
  • Has significant cardiovascular disease
  • Has prolongation of the QTcF ≥470 ms
  • Has an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Evidence of corneal keratopathy or history of corneal transplant
  • 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.
c
Includes epithelial ovarian, primary peritoneal, and fallopian tube. 
d
Recurrence or progression within 6 months of last platinum dose. 
e
Progression on front-line platinum-based chemotherapy or within 3 months of completing front-line treatment.
f
Complete response (CR)/partial response (PR) or recurrence/progression-free interval of more than 6 months from last platinum dose.
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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