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 U.S. registered trademark of CytomX Therapeutics, Inc.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
196
Solution for infusion
Solution for infusion
Tablet
PROCLAIM Investigative Site
Los Angeles, California, United States
PROCLAIM Investigative Site
Los Angeles, California, United States
PROCLAIM Investigative Site
New Haven, Connecticut, United States
PROCLAIM Investigative Site
Chicago, Illinois, United States
PROCLAIM Investigative Site
Indianapolis, Indiana, United States
The Number of Subjects Experiencing a Dose Limiting Toxicity (DLT) at Various Dose Levels When Given Multiple Doses of CX-072 as a Monotherapy or in Combination With Ipilimumab or Vemurafenib
Adverse events (AEs) that were considered DLTs: * Grade 5 AEs * Grade 4 AEs judged by the Investigator to be treatment-related or judged by the Sponsor as a DLT, regardless of Investigator-attribution (with some exceptions) • Any Grade 4 endocrinopathy. * Grade 3 AEs judged by the Investigator to be treatment-related or by the Sponsor, regardless of Investigator-attribution (with some exceptions) • Any Grade 3 central nervous system event, regardless of duration or reversibility. * Grade 2 pneumonitis necessitating CX-072 discontinuation * Grade 2 ocular toxicity necessitating CX-072 discontinuation
Time frame: 28 days (dose limiting toxicity period)
The Percentage of Subjects Experiencing Anti-cancer Activity (ORR) When Given 10 mg/kg CX-072 as Monotherapy
The primary efficacy endpoint, ORR, was defined as the proportion of subjects with complete response (CR) or partial response (PR) on two consecutive tumor assessments according to RECIST v1.1.
Time frame: 2 years
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PROCLAIM Investigative Site
Boston, Massachusetts, United States
PROCLAIM Investigative Site
Detroit, Michigan, United States
PROCLAIM Investigative Site
New York, New York, United States
PROCLAIM Investigative Site
New York, New York, United States
PROCLAIM Investigative Site
New York, New York, United States
...and 21 more locations