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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03149549
Recruitment Status : Terminated (Covid Pandemic; Business Decision to separate Phase 2 to new study)
First Posted : May 11, 2017
Results First Posted : January 5, 2024
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics

Study Description
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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


Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Breast Cancer Non Small Cell Lung Cancer Head and Neck Cancer Ovarian Cancer Drug: CX-2009 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : September 10, 2020
Actual Study Completion Date : September 10, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation
Dose escalation and determination
 Drug: CX-2009
CX-2009 Monotherapy
Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination
Additional enrollment into previously cleared monotherapy dose levels
 Drug: CX-2009
CX-2009 Monotherapy
Experimental: CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion
Dose expansion
 Drug: CX-2009
CX-2009 Monotherapy
Experimental: CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion
Dose escalation and determination in selected tumor types
 Drug: CX-2009
CX-2009 Monotherapy


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy [ Time Frame: Median total on-study follow-up of 18.4 weeks. ]

    Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.

    >

    > For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per

    > RECIST Version 1.1



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149549


Locations
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Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Monika Vainorius, MD CytomX Therapeutics
  Study Documents (Full-Text)

Documents provided by CytomX Therapeutics:
Study Protocol  [PDF] February 20, 2020
Statistical Analysis Plan  [PDF] October 7, 2020

More Information
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03149549    
Other Study ID Numbers: CTMX-M-2009-001
First Posted: May 11, 2017    Key Record Dates
Results First Posted: January 5, 2024
Last Update Posted: January 5, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CytomX Therapeutics:
cancer
solid tumor
PROCLAIM
CX-2009
 PROBODY™ Therapeutic
Drug Conjugate
Antibody drug conjugate
CD166