Brief Title
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)
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
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
The number of subjects experiencing a dose limiting toxicity at various dose levels when given CX-2009 as a monotherapy
Secondary Outcome
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy
Condition
Solid Tumor, Adult
Intervention
CX-2009
Study Arms / Comparison Groups
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
Description: Dose escalation and determination
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
99
Start Date
June 1, 2017
Completion Date
December 2020
Primary Completion Date
October 2020
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ginny Paton, Pharm D, ,
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03149549
Organization ID
CTMX-M-2009-001
Responsible Party
Sponsor
Study Sponsor
CytomX Therapeutics
Study Sponsor
Ginny Paton, Pharm D, Study Director, CytomX Therapeutics
Verification Date
July 2020