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

Trial ID #	NCT02988817
Phase	I/II
Drug Class	Antibody Drug Conjugates: Axl
Drug Name	Enapotamab vedotin
Alternate Drug Names	anti-AXL/MMAE antibody-drug conjugate, anti-AXL monoclonal antibody-MMAE conjugate, HuMax-AXL-ADC
Drugs in Trial	Enapotamab vedotin
Eligible Participant	Advanced solid tumors
Patients Enrolled	47 [22 ovarian; median 4 prior therapies (1-9)]
Therapy Setting	Recurrence
Study Design	Open-Label, Non-randomized
Endpoints	ORR, RP2D, evaluated per RECIST
Efficacy	RP2D: 2.2 mg/kg 1Q3W Treatment arm 1Q3W: ORR: 13% (2PR, n=15)
Clinically Significant Adverse Events	Serious AE: overall (49%) Grade 3-4 AE: overall (53%), gastrointestinal disorders (constipation, vomiting, diarrhea) (34%), neutropenia (11%)
Conclusion	Manageable safety profile and encouraging anti-tumor activity in heavily pretreated patients
Reference	Ameratunga M et al. First in human, dose-escalation, phase (ph) I trial, to evaluate safety of anti-Axl antibody-drug-conjugate (ADC) enapotamab vedotin (EnaV) in solid tumors. J Clin Oncol 37 (2019) (suppl; abstr 2525) https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.2525