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Monoclonal Antibodies

WU-NK-101 + Cetuximab for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by Wugen, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2 at screening.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Summary

This trial aims to test the safety and effectiveness of a new treatment called WU-NK-101 in combination with cetuximab in patients with advanced colorectal cancer (CRC) and head and

Who is the study for?
This trial is for adults with advanced colorectal cancer (CRC) or squamous cell carcinoma of the head and neck (SCCHN) that has worsened despite standard treatments. Participants must have tried all appropriate targeted therapies, have a life expectancy over 12 weeks, measurable disease per RECIST 1.1 criteria, be physically capable of daily activity with limited assistance (ECOG ≤2), and have good heart function.
What is being tested?
The study tests WU-NK-101 in combination with cetuximab to evaluate safety and early anti-tumor effects in two groups: one with CRC and another with SCCHN. It includes a Dose Escalation Phase to find the safe dosage level followed by a Cohort Expansion Phase to further assess its effectiveness.
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions due to cetuximab administration, fatigue, skin rash or itching associated with cetuximab use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and am up and about more than half of the day.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5
Maximum Tolerated Dose
Secondary outcome measures
Duration of Response
Overall Response Rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: WU-NK-101 Monotherapy/Cetuximab combo Run-inExperimental Treatment2 Interventions
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.
Group II: WU-NK-101 /Cetuximab ComboExperimental Treatment2 Interventions
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.

Find a Location

Who is running the clinical trial?

Wugen, Inc.Lead Sponsor
6 Previous Clinical Trials
261 Total Patients Enrolled
Jan Davidson, MD, PhDStudy DirectorWugen, Inc.
2 Previous Clinical Trials
134 Total Patients Enrolled
~20 spots leftby Sep 2025
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