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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

NCT03706274

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CTMX-M-188-001
  • NCT ID: NCT03706274

Conditions

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
CX-188CX-188 Escalation

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
CX-188 EscalationExperimental
  • CX-188
CX-188 Alternative Dosing ScheduleExperimental
  • CX-188

Eligibility 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
      
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-188 as a monotherapy
Time Frame:21 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy
Time Frame:2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:CytomX Therapeutics

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