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
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- TyrNovo Ltd.
- Enrollment
- 110
- Locations
- 10
- Primary Endpoint
- Part 2: Incidence of treatment emergent adverse events
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose escalation of NT219 as a single agent
Intervention: NT219 (Drug)
Dose escalation of NT219 in combination with ERBITUX®
Intervention: NT219 and ERBITUX® - Dose Escalation (Drug)
Expansion cohort of NT219 in combination with ERBITUX®
Intervention: NT219 and ERBITUX® - Expansion (Drug)
Outcomes
Primary Outcomes
Part 2: Incidence of treatment emergent adverse events
Time Frame: 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
Time Frame: Up to 24 months
Incidence of treatment emergent adverse events with single agent NT219
Part 3: Objective Response Rate
Time Frame: 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 Outcomes
- Plasma clearance [Cl](Up to 45 days after first study drug administration)
- 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)
- Volume of distribution at stead-state [Vss](Up to 45 days after first study drug administration)
- 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)
- Plasma half-life [t1/2](Up to 45 days after first study drug administration)
- 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)