Clinical Trials Directory

Trials / Completed

CompletedNCT04474470

A Study to Evaluate NT219 Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer

A Phase 1/2 Study with Open-Label, Dose Escalation Phase Followed by Single-Arm Expansion At the Maximum Tolerated Dose to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of NT219 Injection Alone and in Combination with ERBITUX® (Cetuximab) in Adults with Advanced Solid Tumors and Head and Neck Cancer

Status
Completed
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
52 (actual)
Sponsor
TyrNovo Ltd. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is a phase 1/2, multi-center study with an open-label, dose escalation phase followed by a single-arm expansion phase to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of NT219 alone and in combination with ERBITUX® (cetuximab) in adults with recurrent and/or metastatic solid tumors.

Conditions

Interventions

TypeNameDescription
DRUGNT219Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors
DRUGNT219 and ERBITUX® - Dose EscalationDose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma
DRUGNT219 and ERBITUX® - ExpansionExpansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck

Timeline

Start date
2020-09-03
Primary completion
2024-05-08
Completion
2024-05-08
First posted
2020-07-16
Last updated
2024-09-19

Locations

10 sites across 2 countries: United States, Israel

Regulatory

Source: ClinicalTrials.gov record NCT04474470. Inclusion in this directory is not an endorsement.