Clinical trial NCT03149549: PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
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
Lead sponsor: CytomX Therapeutics
Sponsor class: INDUSTRY
First posted: 2017-05-11
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
timeFrame: 21 days for the Q3W schedule, 28 days for the Q2W schedule
Secondary outcomes:
measure: Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy
timeFrame: Median total on-study follow-up of 18.4 weeks.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine - Yale Cancer Center
state: Connecticut
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: New York
country: United States
facility: New York University (NYU) Clinical Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University College of Physicians & Surgeons, Columbia University
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
city: Fairfax
country: United States
facility: Viriginia Cancer Specialists
state: Virginia
city: Seattle
country: United States
facility: Swedish Cancer Institute (SCI)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin-Carbone Cancer Center
state: Wisconsin
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Locatie VUmc
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarre
city: Barcelona
country: Spain
facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Madrid
country: Spain
facility: Centro Integral Oncologico Clara Campal
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncologia
city: Glasgow
country: United Kingdom
facility: Beatson, West of Scotland Cancer Centre
city: London
country: United Kingdom
facility: Sarah Cannon Research Institute UK Limited
city: Newcastle Upon Tyne
country: United Kingdom
facility: Northern Centre for Cancer Care
Study officials:
affiliation: CytomX Therapeutics
name: Monika Vainorius, MD
role: STUDY_DIRECTOR
References: