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

NCT03149549 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: CTMX-M-2009-001
• Study Type: interventional
• Target: 99
• Locations: 4 countries
• Sites: 26

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

Keywords

cancer; solid tumor; PROCLAIM; CX-2009; PROBODY™ Therapeutic; Drug Conjugate; Antibody drug conjugate; CD166

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy

  All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

  21 days for the Q3W schedule, 28 days for the Q2W schedule

Secondary Outcomes (1)

• Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy

  Median total on-study follow-up of 18.4 weeks.

Study Arms (4)

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

EXPERIMENTAL

Dose escalation and determination

Drug: CX-2009

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

EXPERIMENTAL

Additional enrollment into previously cleared monotherapy dose levels

Drug: CX-2009

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

EXPERIMENTAL

Dose expansion

Drug: CX-2009

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

EXPERIMENTAL

Dose escalation and determination in selected tumor types

Drug: CX-2009

Interventions

CX-2009 DRUG

CX-2009 Monotherapy

CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion; CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination; CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation; CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (26)

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Yale University School of Medicine - Yale Cancer Center

New Haven, Connecticut, 06520, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

New York University (NYU) Clinical Cancer Center

New York, New York, 10016, United States

Location

Columbia University College of Physicians & Surgeons, Columbia University

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Viriginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Swedish Cancer Institute (SCI)

Seattle, Washington, 98104, United States

Location

University of Wisconsin-Carbone Cancer Center

Madison, Wisconsin, 53579, United States

Location

Amsterdam UMC - Locatie VUmc

Amsterdam, 1007, Netherlands

Location

Universitair Medisch Centrum Groningen

Groningen, 9713 GZ, Netherlands

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Instituto Catalan de Oncologia - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hospital Clinic Barcelona

Barcelona, 8036, Spain

Location

Centro Integral Oncologico Clara Campal

Madrid, 28050, Spain

Location

Instituto Valenciano de Oncologia

Valencia, 46009, Spain

Location

Beatson, West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Sarah Cannon Research Institute UK Limited

London, W1G 6AD, United Kingdom

Location

Northern Centre for Cancer Care

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Ovarian Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Limitations and Caveats

This study was terminated early due to the Covid Pandemic and the company's business decision to separate the Phase 2 (part B) course of the study to a separate, new Phase 2 study. The Phase 1 (part A) course of the study was completed and the RP2D was determined. Part B only enrolled 3 patients and the Secondary and other Outcomes were not analyzed.

Results Point of Contact

• Title: Monika Vainorius
• Organization: CytomX Therapeutics

clinicaltrials@cytomx.com

(650) 515-3185

Study Officials

• Monika Vainorius, MD

  CytomX Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 11, 2017
• Study Start: June 1, 2017
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); US (16); ES (5); NL (2)