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ACTIVE NOT RECRUITING
NCT05674526
PHASE1

A Phase 1b Study of WU-NK-101 in Combination With Cetuximab

Sponsor: Wugen, Inc.

View on ClinicalTrials.gov

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

BIOLOGICAL

WU-NK-101 - Dose Escalation

WU-NK-101 administered on Days 1, 15, 30 and 44

DRUG

Cetuximab - Dose Escalation

Cetuximab 500mg/m2 administered on Days 29 and 43

BIOLOGICAL

WU-NK-101 - Cohort Expansion

WU-NK-101 administered on Days 2 and 16

BIOLOGICAL

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