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: Other
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 cancer, 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://meetinglibrary.asco.org/record/172858/abstract