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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149549
Recruitment Status : Completed
First Posted : May 11, 2017
Last Update Posted : August 4, 2021
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

Tracking Information
First Submitted Date  ICMJE May 4, 2017
First Posted Date  ICMJE May 11, 2017
Last Update Posted Date August 4, 2021
Actual Study Start Date  ICMJE June 1, 2017
Actual Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
The number of subjects experiencing a dose limiting toxicity at various dose levels when given CX-2009 as a monotherapy [ Time Frame: 21 days (dose limiting toxicity period) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2017)
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor, Adult
  • Breast Cancer
  • Non Small Cell Lung Cancer
  • Head and Neck Cancer
  • Ovarian Cancer
Intervention  ICMJE Drug: CX-2009
CX-2009 Monotherapy
Study Arms  ICMJE
  • Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
    Dose escalation and determination
    Intervention: Drug: CX-2009
  • Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination
    Additional enrollment into previously cleared monotherapy dose levels
    Intervention: Drug: CX-2009
  • Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion
    Dose expansion
    Intervention: Drug: CX-2009
  • Experimental: CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion
    Dose escalation and determination in selected tumor types
    Intervention: Drug: CX-2009
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2020)
99
Original Estimated Enrollment  ICMJE
 (submitted: May 9, 2017)
150
Actual Study Completion Date  ICMJE September 10, 2020
Actual Primary Completion Date September 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03149549
Other Study ID Numbers  ICMJE CTMX-M-2009-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CytomX Therapeutics
Study Sponsor  ICMJE CytomX Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ginny Paton, Pharm D CytomX Therapeutics
PRS Account CytomX Therapeutics
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP