A Phase I/II Study of CX-2009 to Treat Patients with Inoperable or Metastatic Solid Tumors

Full Title

CTMX-M-2009-001: 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)

Purpose

The purpose of this study is to assess the safety and effectiveness of the investigational drug CX-2009 in patients with inoperable or metastatic breast, non-small cell lung, prostate, ovarian, endometrial, head and neck, or bile duct cancers. CX-2009 is a “probody,” a drug designed to be inactive until it reaches a tumor.

CX-2009 targets a protein on many cancer cells called CD166. Once in the tumor, special proteins activate the drug to kill cancer cells. It is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic breast, non-small cell lung, prostate, ovarian, endometrial, head and neck, and bile duct cancers that continue to grow despite other therapies.
  • At least 30 days must pass between the completion of previous treatment and entry into the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. James Harding at 646-888-4314.

Protocol

17-357

Phase

I

Investigator

Co-Investigators