TerminatedPhase 1 / Phase 2NCT03149549
Official study title

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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCX-2009

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 5, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?26 U.S. locations

Locations may change over time.

Who runs it?CytomX Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
CytomX Therapeutics
Interventions being studied
Drug: CX-2009
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.

Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • USC Norris Comprehensive Cancer CenterLos Angeles, California
  • Yale University School of Medicine - Yale Cancer CenterNew Haven, Connecticut
  • Rush University Medical CenterChicago, Illinois
  • University of ChicagoChicago, Illinois
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
  • New York University (NYU) Clinical Cancer CenterNew York, New York
  • Columbia University College of Physicians & Surgeons, Columbia UniversityNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Providence Portland Medical CenterPortland, Oregon
  • The Sarah Cannon Research InstituteNashville, Tennessee
  • MD Anderson Cancer CenterHouston, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 5, 2024. Always confirm current availability with the study team.

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