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

NCT04474470 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-09-19

No results posted yet for this study

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

  • Solid Tumor, Adult
  • Squamous Cell Carcinoma of Head and Neck
  • Colorectal Adenocarcinoma
  • Metastatic Solid Tumor
  • Recurrent Solid Tumor
  • Head and Neck Cancer

Interventions

DRUG

NT219

Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors

DRUG

NT219 and ERBITUX® - Dose Escalation

Dose 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

DRUG

NT219 and ERBITUX® - Expansion

Expansion 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

Sponsors & Collaborators

  • TyrNovo Ltd.

    lead INDUSTRY

Principal Investigators

  • Michael Schickler, PhD · TyrNovo Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-03
Primary Completion
2024-05-08
Completion
2024-05-08
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474470 on ClinicalTrials.gov