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

Status
Active
Cancer Type
Lung Cancer
Pancreatic Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03485209
Protocol IDs
SGNTV-001 (primary)
NCI-2018-00676
Study Sponsor
Seattle Genetics

Summary

This trial will study tisotumab vedotin to find out whether it is an effective treatment for certain solid tumors and what side effects (unwanted effects) may occur. The treatment will be given to patients every three weeks.

Objectives

The primary goal of this global, open label, multicenter trial is to assess the activity, safety, and tolerability of tisotumab vedotin for the treatment of selected solid tumors. Patients will be treated with single agent tisotumab vedotin every three weeks. Patients who meet eligibility criteria will be enrolled into one of 4 cohorts of tumor types known to express Tissue Factor. These include colorectal cancer, squamous non-small cell lung cancer (NSCLC), exocrine pancreatic adenocarcinoma, and squamous cell carcinoma of the head and neck (SCCHN).
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