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)
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- CytomX Therapeutics
- Enrollment
- 99
- Locations
- 26
- Primary Endpoint
- The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination
Additional enrollment into previously cleared monotherapy dose levels
Intervention: CX-2009 (Drug)
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
Dose escalation and determination
Intervention: CX-2009 (Drug)
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion
Dose expansion
Intervention: CX-2009 (Drug)
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion
Dose escalation and determination in selected tumor types
Intervention: CX-2009 (Drug)
Outcomes
Primary Outcomes
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy
Time Frame: 21 days for the Q3W schedule, 28 days for the Q2W schedule
All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.
Secondary Outcomes
- Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy(Median total on-study follow-up of 18.4 weeks.)