Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumors
Evaluate antitumor activity of tisotumab vedotin as measured by investigator-determined confirmed objective response rate using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- 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, a tyrosine kinase inhibitor, and a checkpoint inhibitor (CPI), if eligible. Patients 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.
- 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
Keywordscolon cancer, pancreatic cancer, metastatic cancer
Principal InvestigatorThomas J George, Jr, M.D.
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