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Clinical Trials in the USA / NCT05674526
Active, not recruiting Phase 1

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

NCT05674526 · tracked via the Priya Life Science USA tracker
Sponsor
Allotera Therapeutics
Phase
Phase 1
Started
2024-05-21
Last updated
2025-04-15

Condition(s) studied

Colorectal Cancer MetastaticSquamous Cell Carcinoma of Head and Neck

Investigational drug(s) / intervention(s)

WU-NK-101 - Dose EscalationCetuximab - Dose EscalationWU-NK-101 - Cohort ExpansionCetuximab - Cohort Expansion

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

Trial sites (2)

FacilityCityRegionStatus
UCSF San Francisco California
Montefiore Medical Center The Bronx New York

More Allotera Therapeutics trials in the USA

A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex) Recruiting
A Long-Term Safety Follow-Up Study for Patients Treat With WU-CART-007 Enrolling by invitation

Other trials for the same condition

A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Head and Neck Cancer Recruiting
A Study Evaluating AB248 Alone or in Combination With Pembrolizumab in Adult Patients With Solid Tumors Active, not recruiting
Phase II Trial of Neoadjuvant and Adjuvant IO102-IO103 and Pembrolizumab KEYTRUDA® in Patients With Resectable Tumors Recruiting
A Study of DM005 in Patients With Advanced Solid Tumors Recruiting
A Study of MGC026 in Participants With Advanced Solid Tumors Recruiting
Official registry record

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.

View NCT05674526 on ClinicalTrials.gov ↗ ← All trials in the USA