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

NCT05674526 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-15

No results posted yet for this study

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.

Conditions

  • Colorectal Cancer Metastatic
  • Squamous Cell Carcinoma of Head and Neck

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

Sponsors & Collaborators

  • Wugen, Inc.

    lead INDUSTRY

Principal Investigators

  • Cherry Thomas, MD · Wugen, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-21
Primary Completion
2025-09-30
Completion
2026-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05674526 on ClinicalTrials.gov