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PIPELINE > TRIAL OVERVIEW

Trial Information
Molecule Overview
PTK7 Antibody-Drug Conjugate
LY4175408
Phase
1
Recruiting
A First-in-Human, Phase 1a/1b Trial to Assess the Safety, Tolerability and Preliminary Efficacy of LY4175408, an Antibody-Drug Conjugate Targeting Protein Kinase 7-Expressing Tumor Cells, in Participants With Selected Advanced Solid Tumorsa
Related Resources:
Trial Enrollment
NCT07046923 Trial
Key Inclusion Criteria
  • Participants aged ≥18 years with histological or cytological diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), endometrial cancer, or triple-negative breast cancer (TNBC)
    • For dose optimization and dose expansion cohorts: Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Received all standard therapies for which the individual was deemed to be an appropriate candidate by the treating investigator; OR the individual is refusing the remaining most appropriate standard of care treatment; OR there is no standard therapy available for the disease
  • For dose optimization/dose expansion, previously treated with:
    • NSCLC: Platinum-based chemotherapy and programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor (if no actionable genomic alterations) or targeted therapy (if actionable genomic alteration is present)
    • SCLC: Platinum-based chemotherapy and PD-1/PD-L1 inhibitor
    • Endometrial cancer: Taxane- and platinum-based chemotherapy and PD-1/PD-L1 inhibitor
    • TNBC: Chemotherapy and PD-1/PD-L1 inhibitor (if PD-L1 combined positive score [CPS] ≥10)
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Adequate organ function as defined per protocol
Key Exclusion Criteria
  • Prior treatment with a protein tyrosine kinase-7 (PTK7) antibody-drug conjugate (ADC) with a topoisomerase I inhibitor payload
    • Prior therapy with a PTK7 ADC with a non-topoisomerase I inhibitor payload OR non-PTK7 ADC with any payload is permitted  
  • Any unresolved toxicities >Grade 1 from prior therapy
  • Known or suspected history of uncontrolled central nervous system (CNS) metastases
  • Has an active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Has prolongation of the QTcF >470 ms
  • Significant cardiovascular disease
  • 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
LY4175408 is administered intravenously. 
For information on trial enrollment, locations, and more, call 1-800-545-5979.
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