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

Protocol: 
AAAR5081
Phase: 
I/II

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

This is a multicenter, dose-finding, and proof of concept study for CX-2009
as monotherapy in subjects with advanced solid tumors. CX-2009 is a Probody
therapeutic 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.

Are you Eligible? (Inclusion Criteria)

Participants must:
1. Be age 18 or older
2. Have histologically confirmed diagnosis of any active metastatic or
locally advanced unresectable solid tumor.
3. Have advanced or metastatic solid tumors with disease progression after
treatment with available therapies that are known to confer clinical
benefit, or are intolerant to treatment in the following indications:
- Breast carcinoma
- Castration-resistant prostate cancer
- Non-small cell lung cancer, including adenocarcinoma and squamous cell
subtypes

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States