Trial ID # | NCT02001623 |
Phase | I/II |
Drug Class | Antibody Drug Conjugates: Tissue Factor |
Drug Name | Tisotumab vedotin |
Alternate Drug Names | HuMax-TF-ADC, TF-011-MMAE |
Drugs in Trial | Tisotumab vedotin |
Eligible Participant | Advanced solid tumors |
Patients Enrolled | 174 [ovarian expansion: 36; median 4 prior therapies (3-6)] |
Therapy Setting | Recurrence |
Study Design | Open-Label, Non-randomized |
Endpoints | ORR, RP2D, evaluated per RECIST |
Efficacy | RP2D: 2.0 mg/kg Tis IV q3w ORR: 15.2% (5PR, n=33) |
Clinically Significant Adverse Events | SAE: any (27%), one death due to pneumonia possibly related to study drug |
Conclusion | Promising activity of tisotumab vedotin in heavily pretreated patients |
Reference | de Bono JS et al. Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial. Lancet (2019) 20: 383-393 |