WU-NK-101 - Dose Escalation: WU-NK-101 administered on Days 1, 15, 30 and 44
Cetuximab - Dose Escalation: Cetuximab 500mg/m2 administered on Days 29 and 43
WU-NK-101 - Cohort Expansion: WU-NK-101 administered on Days 2 and 16
Cetuximab - Cohort Expansion: Cetuximab 500mg/m2 administered on Days 1 and 15
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
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.
Exclusion Criteria:
Experienced toxicities related to prior cetuximab treatment which required permanent discontinuation of cetuximab per the current label.
Primary outcome measure(s)
Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5 — 24 months 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.
Maximum Tolerated Dose — up to 56 days from first dose Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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