Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 165
Summary
- Conditions
- Cervical Cancer
- Endometrial Cancer
- Melanoma
- Non -Small Cell Lung Cancer
- Ovarian Cancer
- Sarcoma
- Thyroid Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The trial consists of two parts; a dose escalation part (phase I, first in- human (FIH)) and an expansion part (phase IIa). The dose escalation part has two dose escalation arms: the first arm investigates a once every 3 weeks (1Q3W) dosing schedule and the second arm investigates a three administra...
The trial consists of two parts; a dose escalation part (phase I, first in- human (FIH)) and an expansion part (phase IIa). The dose escalation part has two dose escalation arms: the first arm investigates a once every 3 weeks (1Q3W) dosing schedule and the second arm investigates a three administrations over 4 weeks (3Q4W) dosing schedule. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in Part 1
Tracking Information
- NCT #
- NCT02988817
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ignace Vergote, Professor Universitair Ziekenhuizen Leuven