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)

NOT ENROLLING
Protocol # :
17-368
Conditions
Solid Tumor, Adult
Breast Cancer
Non Small Cell Lung Cancer
Head and Neck Cancer
Ovarian Cancer
Phase
I/II
Disease Sites
Lip, Oral Cavity and Pharynx
Esophagus
Stomach
Small Intestine
Colon
Rectum
Anus
Liver
Pancreas
Other Digestive Organ
Larynx
Lung
Other Respiratory and Intrathoracic Organs
Bones and Joints
Soft Tissue
Mycosis Fungoides
Other Skin
Breast
Cervix
Corpus Uteri
Ovary
Other Female Genital
Prostate
Other Male Genital
Urinary Bladder
Kidney
Other Urinary
Eye and Orbit
Brain and Nervous System
Thyroid
Unknown Sites
Ill-Defined Sites
Other Endocrine System
Kaposi's Sarcoma
Melanoma, Skin
Principal Investigator
Liu, Joyce, F
Site Research Nurses
Bowes, Brittany, N.
Cavanaugh, Cathleen
Hindenach, Sarah
Hurley-Whalen, Christin
Keis, Rylee
Morrissey, Stephanie, C.
Reyes, Kaitlen, A.

Trial Description

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. PROCLAIM:
PRObody CLinical Assessment In Man CX-2009 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc

Eligibility Requirements

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.

17-368