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
Description
Brief Summary
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.
Phase
N/AInclusion and Exclusion 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.
- 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.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
Presentado por
SC CTSI