West Cancer Center

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

NCT03371979

Malignancy

Small cell lung cancer, SCLC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd line

Investigational Agent

Pegzilarginase and pembrolizumab

Drug Class

Augmented enzyme and PD-1 inhibitor

Dan Vaena, MD

Sponsor

Aeglea Biotherapeutics

Phase

Phase 1

Status

Closed to Accrual

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

Assessment Frequency Link

Path

small cell lung cancer, extensive stage

Dosing Frequency

Control Agents

Study Protocol

Randomized