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

NCT05674526 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: WUN101-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

NK cells; allogeneic NK cells; cetuximab

Outcome Measures

Primary Outcomes (2)

• Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5

  Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until the end of the study visit or at the end of treatment visit.

  24 months

• Maximum Tolerated Dose

  Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab

  up to 56 days from first dose

Secondary Outcomes (2)

• Duration of Response

  24 months

• Overall Response Rate

  24 months

Study Arms (2)

WU-NK-101 Monotherapy/Cetuximab combo Run-in

EXPERIMENTAL

WU-NK-101 is a non-engineered Natural Killer (NK) cell derived from peripheral blood mononuclear cells (PBMC) that is cytokine-reprogrammed, expanded, and cryopreserved to create an allogeneic enhanced memory-like anti-tumor NK cell therapy product. Each 8 week cycle in dose escalation is divided into two 28- days segments. Patients will receive WU-NK-101 (Days 1 and 15) in the first segment and a combination of cetuximab (500mg/m2 on Days 29 and 43) plus WU-NK-101 (Days 30 and 44) in the second segment.

Biological: WU-NK-101 - Dose Escalation; Drug: Cetuximab - Dose Escalation

WU-NK-101 /Cetuximab Combo

EXPERIMENTAL

Patients will receive cetuximab dosed at 500 mg/m2 on Days 1 and 15, and WU-NK-101 on Days 2 and 16, in each 4-week cycle. Depending on response patients may receive up to 6 cycles of treatment.

Biological: WU-NK-101 - Cohort Expansion; Biological: Cetuximab - Cohort Expansion

Interventions

WU-NK-101 - Dose Escalation BIOLOGICAL

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

WU-NK-101 Monotherapy/Cetuximab combo Run-in

Cetuximab - Dose Escalation DRUG

Cetuximab 500mg/m2 administered on Days 29 and 43

WU-NK-101 Monotherapy/Cetuximab combo Run-in

WU-NK-101 - Cohort Expansion BIOLOGICAL

WU-NK-101 administered on Days 2 and 16

WU-NK-101 /Cetuximab Combo

Cetuximab - Cohort Expansion BIOLOGICAL

Cetuximab 500mg/m2 administered on Days 1 and 15

WU-NK-101 /Cetuximab Combo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed diagnosis of advanced and/or metastatic CRC that has failed or progressed beyond first line or higher line standard of care therapy including bevacizumab combination, cetuximab combination, 5-FU based regimens, or checkpoint inhibitors alone or in combination. Patients must have received all targeted therapies for which they are eligible. Patients may be included in this study regardless of mutation status (e.g., RAS-mutant, wild-type, or unknown status, BRAF V600E, etc.) and EGFR expression.
• Or,
• Patients must have a histologically confirmed diagnosis of SCCHN that has failed or progressed beyond first or higher line standard of care therapy including cetuximab alone or in combination, checkpoint inhibitors alone and in combination, or regimens containing radiotherapy. Patients may be included in this study regardless of EGFR expression.

You may not qualify if:

• Experienced toxicities related to prior cetuximab treatment which required permanent discontinuation of cetuximab per the current label.

Sponsors & Collaborators

• Wugen, Inc.: lead

Study Sites (2)

UCSF

San Francisco, California, 94143, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Cherry Thomas, MD

  Wugen, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In dose expansion patients will be enrolled in 2 parallel, disease specific cohorts to further characterize the safety, tolerability and preliminary anti- tumor activity of WU-NK-101 in combination with cetuximab

Study Record Dates

• First Submitted: December 30, 2022
• First Posted: January 6, 2023
• Study Start: May 21, 2024
• Primary Completion: September 30, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

US (2)