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

NCT03149549

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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
  • Prostate Cancer
  • Ovarian Cancer
  • Endometrial Cancer
  • Head and Neck Cancer
  • Cholangiocarcinoma

Interventions

DrugSynonymsArms
CX-2009CX-2009 Escalation

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

NameTypeDescriptionInterventions
CX-2009 EscalationExperimentalMonotherapy CX-2009
  • CX-2009
CX-2009 ExpansionExperimentalMonotherapy CX-2009
  • CX-2009

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:Recruiting
Lead Sponsor:CytomX Therapeutics

Trial Keywords

  • cancer
  • solid tumor
  • PROCLAIM
  • CX-2009
  • PROBODY™ Therapeutic
  • Drug Conjugate
  • Antibody drug conjugate
  • CD166

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