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PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03706274
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : July 30, 2019
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-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: PROCLAIM: PRObody Clinical Assessment in Man CX-188 clinical trial 001

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: CX-188 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CX-188 Escalation Drug: CX-188
CX-188
Experimental: CX-188 Alternative Dosing Schedule Drug: CX-188
CX-188


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-188 as a monotherapy [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy [ Time Frame: 2 years ]

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 advanced unresectable solid tumors that progressed on standard therapy
  2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old

Exclusion Criteria:

  1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
  2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
  3. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
  4. History of or current active autoimmune diseases
  5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications
  6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
  7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
  8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug
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): NCT03706274


Contacts
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Contact: Gary Albert 650-528-2929 clinicaltrials@cytomx.com

Locations
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United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Sponsors and Collaborators
CytomX Therapeutics
Investigators
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Study Director: Yifah Yaron, MD CytomX Therapeutics
More Information
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Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03706274    
Other Study ID Numbers: CTMX-M-188-001
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: March 2019
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
Additional relevant MeSH terms:
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Neoplasms