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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

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ClinicalTrials.gov Identifier: NCT03149549
Recruitment Status : Recruiting
First Posted : May 11, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

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


Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Breast Cancer Non Small Cell Lung Cancer Prostate Cancer Ovarian Cancer Endometrial Cancer Head and Neck Cancer Cholangiocarcinoma Drug: CX-2009 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: CX-2009 Escalation
Monotherapy CX-2009
Drug: CX-2009
CX-2009 Monotherapy

Experimental: CX-2009 Expansion
Monotherapy CX-2009
Drug: CX-2009
CX-2009 Monotherapy




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149549


Contacts
Contact: Lori Carman 650-515-3185 clinicaltrials@cytomx.com

  Show 29 Study Locations
Sponsors and Collaborators
CytomX Therapeutics
Investigators
Study Director: Matthias Will, MD CytomX Therapeutics

Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03149549     History of Changes
Other Study ID Numbers: CTMX-M-2009-001
First Posted: May 11, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CytomX Therapeutics:
cancer
solid tumor
PROCLAIM
CX-2009
PROBODY™ Therapeutic
Drug Conjugate
Antibody drug conjugate
CD166

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Head and Neck Neoplasms
Endometrial Neoplasms
Cholangiocarcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Genital Diseases, Female
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type