SHS_492384 ELLE CCTX 17117

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)

PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors.

Inclusion Criteria:

• Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors

• Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,

• Agreement to provide mandatory archival tissue or fresh biopsy.

• At least 18 years of age.


Exclusion Criteria:

• Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring

• Serious concurrent illness, including clinically relevant active infection

• History of or current active autoimmune diseases

• Significant cardiac disease such as recent myocardial infarction

• 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;

• Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;

• History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;

• Currently receiving anticoagulation therapy with warfarin;

• Major surgery (requiring general anesthesia) within 3 months prior to dosing.
Phase I/II
NCT03149549
Cancer
Breast
Erin Ellis, M.D.
CytomX Therapeutics, Inc.
Mai Berenfeld
  • Swedish Medical Center