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), 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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
  2. Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
  3. Agreement to provide mandatory archival tissue or fresh biopsy.
  4. At least 18 years of age.

Exclusion Criteria:

  1. Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
  2. Serious concurrent illness, including clinically relevant active infection
  3. History of or current active autoimmune diseases
  4. Significant cardiac disease such as recent myocardial infarction
  5. 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;
  6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
  7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
  8. Currently receiving anticoagulation therapy with warfarin;
  9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.
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