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
The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors.
Cancer (Oncology) - Breast,
Cancer (Oncology) - Lung,
Cancer (Oncology) - Prostate,
Cancer (Oncology) - Gynecology,
Cancer (Oncology) - Cholangiocarcinoma,
Cancer (Oncology) - Head and Neck
Erin Ellis, MD
Swedish Cancer Institute
|Ages Eligible for Study:
||18 Years and older (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
- Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
- Agreement to provide mandatory archival tissue or fresh biopsy.
- At least 18 years of age.
- Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
- Serious concurrent illness, including clinically relevant active infection
- History of or current active autoimmune diseases
- Significant cardiac disease such as recent myocardial infarction
- History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
- Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
- History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
- Currently receiving anticoagulation therapy with warfarin;
- Major surgery (requiring general anesthesia) within 3 months prior to dosing.