Lung: Small Cell: Phase 1 (EXPANSION): Second Line: Immunotx: KEYNOTE PN758

A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

Title
Aeglea CAEB1101-101B (KEYNOTE PN758 Small cell)
Study Title

A Phase 1/2 Study of Pegzilarginase (AEB1102, Co-ArgI-PEG) in Combination With Pembrolizumab in the Treatment of Patients With Extensive Disease (ED) Small Cell Lung Cancer (SCLC)

Site Link
Malignancy
Small cell lung cancer, SCLC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd line
Investigational Agent
Pegzilarginase and pembrolizumab
Drug Class
Augmented enzyme and PD-1 inhibitor
PI
Dan Vaena, MD
Sponsor
Aeglea Biotherapeutics
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Extensive stage small-cell lung cancer
  • Has progressed within 6 months of receiving platinum based therapy or intolerant of platinum based therapy
  • ECOG PS 0-1
  • No more than 2 platinum-based regimens for SCLC
  • No prior receipt of PD-1/L-1 agents or CTLA-4 inhibitors
  • No active CNS mets
    • If history of CNS mets, must be stable for at least 4 weeks, and off steroids for at least 7 days
  • No active autoimmune disease requiring treatment in previous 2 years
  • Cannot be receiving more than 3 anti-hypertensive agents
  • No known HIV/HBV/HCV
Objective

Primary (Phase 1): Incidence of treatment-related AE. (Phase 2): ORR.  Secondary- ORR, CBR, TtR, DoR, PFS, OS, Safety

Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
small cell lung cancer, extensive stage
Dosing Frequency
Control Agents
Study Protocol
Randomized
No
X