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

Breast Cancer Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03149549
• Other study ID #: CTMX-M-2009-001
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 1, 2017
• Est. completion date: September 10, 2020

Study information

• Verified date: January 2024
• Source: CytomX Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 99
• Est. completion date: September 10, 2020
• Est. primary completion date: September 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• CX-2009
CX-2009 Monotherapy

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC - Locatie VUmc	Amsterdam
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Instituto Catalan de Oncologia - Hospital Duran i Reynals	Barcelona
Spain	Centro Integral Oncologico Clara Campal	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarre
Spain	Instituto Valenciano de Oncologia	Valencia
United Kingdom	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 States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Viriginia Cancer Specialists	Fairfax	Virginia
United States	MD Anderson Cancer Center	Houston	Texas
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Wisconsin-Carbone Cancer Center	Madison	Wisconsin
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale University School of Medicine - Yale Cancer Center	New Haven	Connecticut
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	New York University (NYU) Clinical Cancer Center	New York	New York
United States	Providence Portland Medical Center	Portland	Oregon
United States	Huntsman Cancer Institute	Salt Lake City	Utah
United States	Swedish Cancer Institute (SCI)	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Countries where clinical trial is conducted

United States,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy	Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.; >; > For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per; > RECIST Version 1.1	Median total on-study follow-up of 18.4 weeks.