Description:
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
Title
- 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)
Clinical Trial IDs
- ORG STUDY ID:
CTMX-M-2009-001
- NCT ID:
NCT03149549
Conditions
- Solid Tumor, Adult
- Breast Cancer
- Non Small Cell Lung Cancer
- Head and Neck Cancer
- Ovarian Cancer
Interventions
Drug | Synonyms | Arms |
---|
CX-2009 | | CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion |
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
Trial Arms
Name | Type | Description | Interventions |
---|
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation | Experimental | Dose escalation and determination | |
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination | Experimental | Additional enrollment into previously cleared monotherapy dose levels | |
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion | Experimental | Dose expansion | |
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion | Experimental | Dose escalation and determination in selected tumor types | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | CytomX Therapeutics |
Trial Keywords
- cancer
- solid tumor
- PROCLAIM
- CX-2009
- PROBODY™ Therapeutic
- Drug Conjugate
- Antibody drug conjugate
- CD166
Last Updated
August 4, 2021