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PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

NCT03013491

Description:

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a trademark of CytomX Therapeutics, Inc.

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: PROCLAIM-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas
  • Official Title: An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: CTMX-M-072-001
  • NCT ID: NCT03013491

Conditions

  • Solid Tumor
  • Lymphoma

Interventions

DrugSynonymsArms
CX-072CX-072
ipilimumabCX-072 with Ipilimumab #1
vemurafenibCX-072 with Vemurafenib

Purpose

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-001: PRObody CLinical Assessment In Man CX-072 clinical trial 001 CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity. PROBODY is a trademark of CytomX Therapeutics, Inc.

Trial Arms

NameTypeDescriptionInterventions
CX-072ExperimentalMonotherapy CX-072
  • CX-072
CX-072 with Ipilimumab #1ExperimentalCombination CX-072 + ipilimumab (Schedule 1)
  • CX-072
  • ipilimumab
CX-072 with Ipilimumab #2ExperimentalCombination CX-072 + ipilimumab (Schedule 2)
  • CX-072
  • ipilimumab
CX-072 with VemurafenibExperimentalCombination CX-072 + vemurafenib
  • CX-072
  • vemurafenib
CX-072 expansionExperimentalMonotherapy CX-072 expansion
  • CX-072

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that
             progressed on standard therapy

          2. Agreement to provide mandatory archival tissue or fresh biopsy.

          3. At least 18 years of age.

        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. Active or history of uveal, mucosal, or ocular melanoma. 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, including but not limited to
             inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune
             hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis,
             autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.

          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 multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
Time Frame:28 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 multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib
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
  • checkpoint inhibitor
  • monotherapy
  • combination
  • PD-L1
  • CTLA-4
  • solid tumor
  • lymphoma
  • BRAF
  • PROCLAIM
  • CX-072
  • PROCLAIM-072

Last Updated

March 24, 2017