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)

B
Bert O'Neil, MD

Primary Investigator

Overview

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.

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.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Solid Tumor, Cancer
  • Age: Between 18 Years - 100 Years
  • Gender: All

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
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

Updated on 19 Apr 2024. Study ID: 1704232682 (CTMX-M-2009-001)

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