Trial | NCT03013491  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    300
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.
Study Started
Jan 31
2017
Primary Completion
Oct 06
2021
Study Completion
Oct 06
2021
Last Update
Feb 09
2022

Drug CX-072

Drug ipilimumab

Drug vemurafenib

CX-072 Experimental

Monotherapy CX-072

CX-072 with Ipilimumab #1 Experimental

Combination CX-072 + ipilimumab (Schedule 1)

CX-072 with Ipilimumab #2 Experimental

Combination CX-072 + ipilimumab (Schedule 2)

CX-072 with Vemurafenib Experimental

Combination CX-072 + vemurafenib

CX-072 expansion Experimental

Monotherapy CX-072

Criteria 

Inclusion Criteria:

Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
Agreement to provide mandatory archival tissue or fresh biopsy.
At least 18 years of age.

Exclusion Criteria:

Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.
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.
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.
History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.
History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.
Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.
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.
No Results Posted