PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investig

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

https://clinicaltrials.gov/ct2/show/NCT03149549

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Purpose
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 Intervention 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
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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)

Resource links provided by NLM:

Genetics Home Reference related topics: cholangiocarcinoma lung cancer
MedlinePlus related topics: Cancer
Genetic and Rare Diseases Information Center resources: Ovarian Cancer
U.S. FDA Resources

Further study details as provided by CytomX Therapeutics:

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

Estimated Enrollment: 150
Anticipated Study Start Date: June 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Eligibility

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
Agreement to provide mandatory archival tissue or fresh biopsy.
At least 18 years of age.
Exclusion Criteria:

Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
Serious concurrent illness, including clinically relevant active infection
History of or current active autoimmune diseases
Significant cardiac disease such as recent myocardial infarction
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;
Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
Currently receiving anticoagulation therapy with warfarin;
Major surgery (requiring general anesthesia) within 3 months prior to dosing.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03149549

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

Locations
United States, Virginia
Viriginia Cancer Specialists Not yet recruiting
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
CytomX Therapeutics
Investigators
Study Director: Matthias Will, MD CytomX Therapeutics
More Information

Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03149549 History of Changes
Other Study ID Numbers: CTMX-M-2009-001
Study First Received: May 4, 2017
Last Updated: May 9, 2017
Individual Participant Data
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

ClinicalTrials.gov processed this record on May 12, 2017