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 (PROCLAIM-CX-2009)
| Sponsor: |
CytomX Therapeutics, Inc. |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
AAAR5081 |
| U.S. Govt. ID: |
NCT03149549 |
| Contact: |
Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu |
This is the first study in humans for an investigational drug called CX-2009. 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 a maytansine derivative (a cancer killing therapy). The study is being done to look at the possible side effects, safety and tolerability of CX-2009. If you qualify for the study, you will be placed in one of 3 study parts (Part A, A2, and B). Each study part will consist of a screening period, treatment period, and follow-up period. Cancer types: breast cancer, castration-resistant prostate cancer, non-small cell lung cancer, epithelial ovarian cancer, endometrial cancer, head and neck squamous cell cancer, or cholangiocarcinoma (bile duct cancer).
This study is closed
Investigator
Emerson Lim, MD
| Are you 18 years or older? |
Yes |
No |
| Have you been diagnosed with one of the cancers listed in the description? |
Yes |
No |
| Does your cancer continue to grow? |
Yes |
No |