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A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
NCT05674526 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- BIOLOGICAL WU-NK-101 - Dose Escalation
- DRUG Cetuximab - Dose Escalation
- BIOLOGICAL WU-NK-101 - Cohort Expansion
- BIOLOGICAL Cetuximab - Cohort Expansion
Study Locations (2)
California
- UCSF — San Francisco
New York
- Montefiore Medical Center — The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-05-21 |
| Est. Completion | 2026-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05674526
The ClinicalTrials.gov registry entry for NCT05674526 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wugen, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Squamous Cell Carcinoma of Head and Neck appearing as the primary indexed condition, and to 4 interventions — of which WU-NK-101 - Dose Escalation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05674526 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05674526 about?
NCT05674526 is a clinical study titled "A Phase 1b Study of WU-NK-101 in Combination With Cetuximab". 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). Th...
What is the current status of trial NCT05674526?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-05-21. Estimated completion is 2026-06-01.
What conditions does trial NCT05674526 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of Head and Neck, Colorectal Cancer Metastatic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05674526?
The interventions under investigation include: WU-NK-101 - Dose Escalation (BIOLOGICAL), Cetuximab - Dose Escalation (DRUG), WU-NK-101 - Cohort Expansion (BIOLOGICAL), Cetuximab - Cohort Expansion (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05674526?
This trial is sponsored by Wugen, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05674526 being conducted?
This trial has 2 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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