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

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)

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 Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

The number of subjects experiencing a dose limiting toxicity at various dose levels when given CX-2009 as a monotherapy

Secondary Outcome

 The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2009 as a monotherapy

Condition

Solid Tumor, Adult

Intervention

CX-2009

Study Arms / Comparison Groups

 CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation

Description:  Dose escalation and determination

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

June 1, 2017

Completion Date

September 10, 2020

Primary Completion Date

September 10, 2020

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.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ginny Paton, Pharm D, ,

Location Countries

Netherlands

Location Countries

Netherlands

Administrative Informations

NCT ID

NCT03149549

Organization ID

CTMX-M-2009-001

Responsible Party

Sponsor

Study Sponsor

CytomX Therapeutics

Study Sponsor

Ginny Paton, Pharm D, Study Director, CytomX Therapeutics

Verification Date

January 2021