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A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors
This is the first study in humans for an investigational drug called CX-2009. This means that CX-2009 is still being tested and is not approved to become a routine therapy for treating patients by any regulatory authority, including the United States Food and Drug Administration (FDA). CX-2009 is allowed to be used only by researchers in clinical studies like this one. Different doses of CX-2009 will be given in the study depending on results found in earlier stages of the study for each dose.
CX-2009 is a Probody therapeutic containing a masked antibody (an antibody is a protein naturally occurring in the human body to fight infections and in some cases tumors) attached to maytansine (a cancer killing therapy). Probody therapeutics are drugs that when administered are not active, but later become active in your body when the mask is removed. The CX-2009 Probody is designed to be activated by enzymes that occur in the region of the cancer, but not elsewhere in the body. Therefore, the drug will mostly be activated in areas where your cancer is. The specific antibody that is a part of CX-2009 targets an antigen (marker on cells) called CD166. CD166 is common on many tumors. Once the active antibody recognizes cells it will deliver the cancer killing therapy, maytansine, to your tumor with the aim of shrinking your cancer.
Separate groups of patients will be tested with one of up to seven different doses of CX-2009 (study drug). You will receive the study drug for a period of time until your disease worsens, or your study doctor believes that you are no longer receiving benefit. It is estimated that this period will be approximately six months. During this period, you will have study procedures/tests performed and you will receive the study drug every 21 days by infusion.
- Histologically confirmed diagnosis of any active metastatic or locally advanced unresectable solid tumor
- Agrees to provide tumor tissue; archival, new, or recent acquisition confirmed to be available prior to initiation of study drug
- Subjects with treated brain metastases are eligible if the brain metastases are stable and the subject does not require radiation therapy, or steroids
- At least 18 years of age
- Women of childbearing potential and males must agree to use a highly effective method of contraception prior to study entry, while on study drug, and for a period of 50 days following the last treatment
- Patients with neuropathy greater than Grade 1 are excluded
- Patients with active or chronic corneal disorder are excluded
- Patients with advanced or metastatic Stage IV NSCLC subjects with epidermal growth factor receptor or
anaplastic lymphoma kinase genomic alterations unless they have progressed on treatment with
appropriate targeted therapy are excluded
- Patients with any other anti-cancer treatment such as chemotherapy, immunotherapy, biochemotherapy,
radiotherapy, investigative therapy, or high-dose steroids within 30 days of receiving study are excluded
- Patients with a history of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy are excluded
- Patients who are currently receiving anticoagulation therapy with warfarin are excluded
- Patients who have undergone major surgery (requiring general anesthesia) within 3 months prior to dosing are excluded. Subjects who have undergone major surgery within this time period may be enrolled, if, in the Investigators judgment, wound healing has largely resolved
- Women who are pregnant or breast feeding are excluded
Applicable Disease Sites
Breast; Cervix; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Lung; Ovary; Prostate
UW Hospital and Clinics