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A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
Sponsor: Wugen, Inc.
Summary
This study is a Phase 1b open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic CRC (Cohort 1), and in patients with advanced and/or metastatic SCCHN (Cohort 2). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.
Official title: A Phase 1b Study of WU-NK-101 in Combination With Cetuximab for Advanced and/or Metastatic Colorectal Cancer (CRC) and Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2024-05-21
Completion Date
2026-06-01
Last Updated
2025-04-15
Healthy Volunteers
No
Interventions
WU-NK-101 - Dose Escalation
WU-NK-101 administered on Days 1, 15, 30 and 44
Cetuximab - Dose Escalation
Cetuximab 500mg/m2 administered on Days 29 and 43
WU-NK-101 - Cohort Expansion
WU-NK-101 administered on Days 2 and 16
Cetuximab - Cohort Expansion
Cetuximab 500mg/m2 administered on Days 1 and 15
Locations (2)
UCSF
San Francisco, California, United States
Montefiore Medical Center
The Bronx, New York, United States