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

Official Title

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

Summary:

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumours and what side effects (unwanted effects) may occur. There are three parts to this study. In Part A, the treatment will be given to participants every 3 weeks (3-week cycles). In Part B, participants will receive tisotumab vedotin on Days 1, 8, and 15 every 4-week cycle. In Part C, participants may receive tisotumab vedotin on Days 1 and 15 or Days 1, 8, and 15 on a 4-week cycle.

Trial Description

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).

View this trial on ClinicalTrials.gov