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

Phase 1

Active, not recruiting

• Conditions: Squamous Cell Carcinoma of Head and Neck; Colorectal Adenocarcinoma; Head and Neck Cancer; Solid Tumor, Adult; Metastatic Solid Tumor; Recurrent Solid Tumor
• Interventions: Drug: NT219; Drug: NT219 and ERBITUX® - Dose Escalation; Drug: NT219 and ERBITUX® - Expansion

• Registration Number: NCT04474470
• Lead Sponsor: TyrNovo Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-30
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-16
• Study Start: 2020-09-03
• Status Verified: 2024-05
• Primary Completion: 2024-05-08
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-09
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose escalation of NT219 as a single agent	NT219	-
Dose escalation of NT219 in combination with ERBITUX®	NT219 and ERBITUX® - Dose Escalation	-
Expansion cohort of NT219 in combination with ERBITUX®	NT219 and ERBITUX® - Expansion	-

Primary Outcome Measures

Name	Time	Method
Part 2: Incidence of treatment emergent adverse events	Up to 24 months	Incidence of treatment emergent adverse events with NT219 administered in combination with ERBITUX®
Part 1: Incidence of treatment emergent adverse events	Up to 24 months	Incidence of treatment emergent adverse events with single agent NT219
Part 3: Objective Response Rate	Up to 24 months	Objective Response Rate when phase 2 dose of NT219 is used in combination with ERBITUX® in adults with recurrent and/or metastatic SCCHN

Secondary Outcome Measures

Name	Time	Method
Plasma clearance [Cl]	Up to 45 days after first study drug administration	Plasma clearance \[Cl\] of NT219
Objective Response Rate when NT219 is used as monotherapy	Up to 24 months
Overall Survival when NT219 is used in combination with ERBITUX®	Up to 24 months
Maximum plasma concentration [Cmax]	Up to 45 days after first study drug administration	Maximum plasma concentration \[Cmax\] of NT219
Volume of distribution at stead-state [Vss]	Up to 45 days after first study drug administration	Volume of distribution at stead-state \[Vss\] of NT219
Disease Control Rate when NT219 is used as monotherapy	Up to 24 months
Progression Free Survival when NT219 is used as monotherapy	Up to 24 months
Duration of Response when NT219 is used in combination with ERBITUX®	Up to 24 months
Time to Response when NT219 is used in combination with ERBITUX®	Up to 24 months
Disease Control Rate when NT219 is used in combination with ERBITUX®	Up to 24 months
Progression Free Survival when NT219 is used in combination with ERBITUX®	Up to 24 months
Time to Progression when NT219 is used in combination with ERBITUX®	Up to 24 months
Area under the plasma concentration curve [AUC]	Up to 45 days after first study drug administration	Area under the plasma concentration curve \[AUC\] of NT219
Plasma half-life [t1/2]	Up to 45 days after first study drug administration	Plasma half-life \[t1/2\] of NT219
Duration of Response when NT219 is used as monotherapy	Up to 24 months
Time to Response when NT219 is used as monotherapy	Up to 24 months
Time to Progression when NT219 is used as monotherapy	Up to 24 months
Overall Survival when NT219 is used as monotherapy	Up to 24 months
Objective Response Rate when NT219 is used in combination with ERBITUX®	Up to 24 months

Trial Locations

Locations (10)

California Cancer Associates for Research and Excellence; 🇺🇸 Encinitas, California, United States

The Angeles Clinic and Research Institute; 🇺🇸 Los Angeles, California, United States

UCSD Moores Cancer Center; 🇺🇸 San Diego, California, United States

MedStar Georgetown University Hospital; 🇺🇸 Washington, D.C., District of Columbia, United States

The University of Chicago and Biological Sciences; 🇺🇸 Chicago, Illinois, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Hadassah University Medical Center; 🇮🇱 Jerusalem, Israel

Rabin Medical Center; 🇮🇱 Petah tikva, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel