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

NCT ID: NCT03149549

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-09-10

Brief 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

Conditions

Solid Tumor, Adult; Breast Cancer; Non Small Cell Lung Cancer; Head and Neck Cancer; Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation

Dose escalation and determination

Group Type: EXPERIMENTAL

CX-2009

Intervention Type: DRUG

CX-2009 Monotherapy

CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination

Additional enrollment into previously cleared monotherapy dose levels

Group Type: EXPERIMENTAL

CX-2009

Intervention Type: DRUG

CX-2009 Monotherapy

CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion

Dose expansion

Group Type: EXPERIMENTAL

CX-2009

Intervention Type: DRUG

CX-2009 Monotherapy

CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion

Dose escalation and determination in selected tumor types

Group Type: EXPERIMENTAL

CX-2009

Intervention Type: DRUG

CX-2009 Monotherapy

Interventions

CX-2009

CX-2009 Monotherapy

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytomX Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Monika Vainorius, MD

Role: STUDY_DIRECTOR

CytomX Therapeutics

Locations

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

New York University (NYU) Clinical Cancer Center

New York, New York, United States

Columbia University College of Physicians & Surgeons, Columbia University

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

Viriginia Cancer Specialists

Fairfax, Virginia, United States

Swedish Cancer Institute (SCI)

Seattle, Washington, United States

University of Wisconsin-Carbone Cancer Center

Madison, Wisconsin, United States

Amsterdam UMC - Locatie VUmc

Amsterdam, , Netherlands

Universitair Medisch Centrum Groningen

Groningen, , Netherlands

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Instituto Catalan de Oncologia - Hospital Duran i Reynals

Barcelona, , Spain

Hospital Clinic Barcelona

Barcelona, , Spain

Centro Integral Oncologico Clara Campal

Madrid, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Beatson, West of Scotland Cancer Centre

Glasgow, , United Kingdom

Sarah Cannon Research Institute UK Limited

London, , United Kingdom

Northern Centre for Cancer Care

Newcastle upon Tyne, , United Kingdom

Countries

United States; Netherlands; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CTMX-M-2009-001

Identifier Type: -

Identifier Source: org_study_id