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NCT05674526 · ClinicalTrials.gov registry record · Phase 1
A Phase 1b Study of WU-NK-101 in Combination With Cetuximab
A Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Colorectal Cancer Metastatic, sponsored by Wugen.
- Active
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT05674526: Active Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Colorectal Cancer Metastatic, sponsored by Wugen.
NCT05674526 is a Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Colorectal Cancer Metastatic that is active but no longer recruiting, run by Wugen. The registered enrollment target is 30 participants, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05674526, a Phase 1 study of Squamous Cell Carcinoma of Head and Neck and Colorectal Cancer Metastatic, is active but no longer recruiting, sponsored by Wugen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
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 |
What the registry record for NCT05674526 still lists
NCT05674526 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 170-participant average among 37 other Squamous Cell Carcinoma of Head and Neck trials with a reported enrollment target (82% lower).
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.
NCT05674526 reports a single indexed study location in California, New York.
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.
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).
Who is sponsoring clinical trial NCT05674526?
This trial is sponsored by Wugen, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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