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

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).

Inclusion Criteria:

• Relapsed, locally-advanced or metastatic colorectal or pancreatic cancer, squamous NSCLC, or SCCHN patients who are not candidates for standard therapy.
• All patients must have experienced disease progression on or after their most recent systemic therapy.
• Baseline measurable disease as measured by RECIST v1. 1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
• Colorectal cancer patients must have received prior therapy with each of following agents, if eligible: a fluoropyrimidine, oxaliplatin, irinotecean, and/or bevacizumab. Patients should have received no more than 3 systemic regimens in the metastatic setting.
• Patients with NSCLC must have predominant squamous histology. Patients must have received prior therapy with a platinum-based treatment and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the locally advanced or metastatic setting.
• Patients with exocrine pancreatic adenocarcinoma must have predominant adenocarcinoma histology. Patients must have received prior therapy with a gemcitabine-based or 5FU-based regimen, if eligible, and should have received no more than 1 systemic regimen in the unresectable or metastatic setting.
• Patients with SCCHN must have received prior therapy with a platinum-based regimen and a checkpoint inhibitor (CPI), if eligible, and should have received no more than 2 systemic regimens in the recurrent/metastatic setting.

Exclusion Criteria:

• Active bleeding conditions
• Ocular surface disease at the time of enrollment
• Pulmonary disease requiring chronic medical therapy, unrelated to underlying cancer
• Uncontrolled tumor-related pain
• Peripheral neuropathy greater than or equal to Grade 2
• History of another malignancy within 3 years of the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
• Active or previous brain metastasis
• Patients who are breastfeeding, pregnant, or planning to become pregnant from the time of informed consent until 6 months after the final study dose is administered
• For patients with SCCHN or NSCLC, ongoing anticoagulant therapy