Efficacy and Safety Study of Tisotumab Vedotin for Patients With Solid Tumours

Titre officiel

Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumours

Sommaire:

Cet essai portant sur le tisotumab vedotin visera à déterminer s’il s’agit d’un traitement efficace pour lutter contre certaines tumeurs solides et quels sont les effets secondaires (indésirables) potentiels. Le traitement sera administré aux patients toutes les trois semaines.

Description de l'essai

Primary Outcome:

• Confirmed Objective Response Rate (ORR)

Secondary Outcome:

• Incidence of Adverse Events
• Confirmed and Unconfirmed ORR
• Disease Control Rate (DCR)
• Duration of Response (DOR)
• Time to Response (TTR)
• Progression-free survival (PFS)
• Overall Survival (OS)
• Cmax
• Ctrough
• Incidence of ATAs

The primary goal of this trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumours. Patients will be treated with single agent tisotumab vedotin. Patients who meet eligibility criteria will be enrolled into cohorts based on tumour type. Tumour types to be evaluated include colorectal cancer, squamous non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).

Voir cet essai sur ClinicalTrials.gov