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

Study Overview
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Brief Summary
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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

Official Title
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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)

Conditions
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Solid Tumor, Adult, Breast Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Ovarian Cancer

Intervention / Treatment
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* Drug: CX-2009


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation<br>Dose escalation and determination | Drug: CX-2009<br>* CX-2009 Monotherapy<br>|
| Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination<br>Additional enrollment into previously cleared monotherapy dose levels | Drug: CX-2009<br>* CX-2009 Monotherapy<br>|
| Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion<br>Dose expansion | Drug: CX-2009<br>* CX-2009 Monotherapy<br>|
| Experimental: CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion<br>Dose escalation and determination in selected tumor types | Drug: CX-2009<br>* CX-2009 Monotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of subjects experiencing a dose limiting toxicity at various dose levels when given CX-2009 as a monotherapy |  | 21 days (dose limiting toxicity period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug Conjugate, Antibody drug conjugate, CD166, cancer, solid tumor, PROCLAIM, CX-2009, PROBODY™ Therapeutic