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

Part of paid clinical trials in Los Angeles, California.

Sponsor
CytomX Therapeutics
Study ID
NCT03013491
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CX-072 — DRUG
    Solution for infusion
  • ipilimumab — DRUG
    Solution for infusion
  • vemurafenib — DRUG
    Tablet

Study Details

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.

Key Dates

Start date
Jan 19, 2017
Status verified
May 2025
Primary completion
Oct 27, 2020
Completion
Oct 27, 2020

Study Design

Enrollment
196 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CX-072 #1
    Monotherapy CX-072 (Part A)
  • Experimental: CX-072 #2
    Monotherapy CX-072 (Part A2)
  • Experimental: CX-072 with Ipilimumab #1
    Combination CX-072 + ipilimumab (Part B1)
  • Experimental: CX-072 with Ipilimumab #2
    Combination CX-072 + ipilimumab (Part B2)
  • Experimental: CX-072 with Vemurafenib
    Combination CX-072 + vemurafenib (Part C)
  • Experimental: CX-072 expansion
    Monotherapy CX-072 (Part D)
  • Experimental: CX-072 long-term extension
    Monotherapy CX-072

Primary Outcome Measure

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 [ Time Frame: 28 days (dose limiting toxicity period) ]

Locations (16)

FacilityCityStateZIPSite coordinators
PROCLAIM Investigative SiteLos AngelesCalifornia90025-
PROCLAIM Investigative SiteLos AngelesCalifornia90033-
PROCLAIM Investigative SiteNew HavenConnecticut06520-
PROCLAIM Investigative SiteChicagoIllinois60612-
PROCLAIM Investigative SiteIndianapolisIndiana46202-
PROCLAIM Investigative SiteBostonMassachusetts02215-
PROCLAIM Investigative SiteDetroitMichigan48201-
PROCLAIM Investigative SiteNew YorkNew York10016-
PROCLAIM Investigative SiteNew YorkNew York10032-
PROCLAIM Investigative SiteNew YorkNew York10065-
PROCLAIM Investigative SitePortlandOregon97213-
PROCLAIM Investigative SiteNashvilleTennessee37203-
PROCLAIM Investigative SiteDallasTexas75230-
PROCLAIM Investigative SiteHoustonTexas77030-
PROCLAIM Investigative SiteFairfaxVirginia22031-
PROCLAIM Investigative SiteMadisonWisconsin53579-

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By research site
PROCLAIM Investigative Site· Los Angeles, CAPROCLAIM Investigative Site· New Haven, CTPROCLAIM Investigative Site· Chicago, ILPROCLAIM Investigative Site· Indianapolis, INPROCLAIM Investigative Site· Boston, MAPROCLAIM Investigative Site· Detroit, MI

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