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First-in-Human, Open-Label, Dose-Escalation Trial with Expansion Cohorts to Evaluate Safety of Axl-Specific Antibody-Drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients with Solid Tumors
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
Primary Objective: To determine the MTD and to establish the safety profile of enapotamab vedotin in amixed population of patients with specified solid tumors. Secondary Objectives: To evaluate the safety laboratory parameters of enapotamab vedotin in a mixed population of patients with specified solid tumors. To establish the PK profile and evaluate immunogenicity of enapotamab vedotin after single and multiple infusions. To evaluate the antitumor activity of enapotamab vedotin in a mixed population of patients with specified solid tumors. To evaluate Axl expression in tumor biopsies from a mixed population of patients with specified solid tumors. Exploratory Objective: To explore biomarkers predictive of response and resistance to enapotamab vedotin.
Enapotamab Vedotin ()