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Trial record 1 of 1 for:    CX-072
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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

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by CytomX Therapeutics
Sponsor:
Information provided by (Responsible Party):
CytomX Therapeutics
ClinicalTrials.gov Identifier:
NCT03013491
First received: December 26, 2016
Last updated: August 22, 2017
Last verified: August 2017
  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-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.


Condition Intervention Phase
Solid Tumor Lymphoma Drug: CX-072 Drug: ipilimumab Drug: vemurafenib Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by CytomX Therapeutics:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: January 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CX-072
Monotherapy CX-072
Drug: CX-072
Experimental: CX-072 with Ipilimumab #1
Combination CX-072 + ipilimumab (Schedule 1)
Drug: CX-072 Drug: ipilimumab
Experimental: CX-072 with Ipilimumab #2
Combination CX-072 + ipilimumab (Schedule 2)
Drug: CX-072 Drug: ipilimumab
Experimental: CX-072 with Vemurafenib
Combination CX-072 + vemurafenib
Drug: CX-072 Drug: vemurafenib
Experimental: CX-072 expansion
Monotherapy CX-072 expansion
Drug: CX-072

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03013491

Contacts
Contact: Lori Carman clinicaltrials@cytomx.com

  Show 30 Study Locations
Sponsors and Collaborators
CytomX Therapeutics
Investigators
Study Director: Matthias Will, M.D. CytomX Therapeutics
  More Information

Responsible Party: CytomX Therapeutics
ClinicalTrials.gov Identifier: NCT03013491     History of Changes
Other Study ID Numbers: CTMX-M-072-001
Study First Received: December 26, 2016
Last Updated: August 22, 2017

Keywords provided by CytomX Therapeutics:
CX-072
PROCLAIM-CX-072
cancer
checkpoint inhibitor
monotherapy
combination
PD-L1
CTLA-4
solid tumor
lymphoma
BRAF
PROCLAIM

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 19, 2017