First-in-human, Dose-escalating Safety Study of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax® TF ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor

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
Grade 3-4 AE: any (59%), fatigue (10%)
69% of patients experienced low grade epitaxis, 60% of patients experienced low grade ocular events and 43% of patients experienced low grade neuropathy

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
https://www.ncbi.nlm.nih.gov/pubmed/30745090

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