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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

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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

Tracking Information
First Submitted Date  ICMJE October 11, 2018
First Posted Date  ICMJE October 15, 2018
Last Update Posted Date July 30, 2019
Estimated Study Start Date  ICMJE January 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy [ Time Frame: 21 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03706274 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2018)
The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy [ Time Frame: 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors
Official Title  ICMJE A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Solid Tumor, Adult
Intervention  ICMJE Drug: CX-188
CX-188
Study Arms  ICMJE
  • Experimental: CX-188 Escalation
    Intervention: Drug: CX-188
  • Experimental: CX-188 Alternative Dosing Schedule
    Intervention: Drug: CX-188
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 11, 2018)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gary Albert 650-528-2929 clinicaltrials@cytomx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03706274
Other Study ID Numbers  ICMJE CTMX-M-188-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CytomX Therapeutics
Study Sponsor  ICMJE CytomX Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yifah Yaron, MD CytomX Therapeutics
PRS Account CytomX Therapeutics
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP