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

Open to people ages 18 years and up

• 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, irinotecan, 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. Patients should have received no more than 2 systemic regimens in the metastatic setting.
• Patients eligible for a tyrosine kinase inhibitor should have received such therapy. These patients should have received no more than 3 systemic regimens in the 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 3 systemic regimens in the recurrent/metastatic setting.

• Active bleeding conditions
• Ocular surface disease at the time of enrollment (Note: cataract is not considered active ocular surface disease for this protocol)
• 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