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Trial Summary

Protocol No.CTMX-M-072-001
StatusOPEN TO ACCRUAL
Principal InvestigatorO'Neil, Bert
ScopeNational
PhasePhase I
Age GroupAdult
TitleAN 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 ANTI-PD-1/PD-L1 INHIBITOR NAIVE SUBJECTS WITH ADVANCED OR RECURRENT SOLID TUMORS OR LYMPHOMAS
DescriptionThe 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-001: PRObody CLinical Assessment In Man CX-072 clinical trial 001

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.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy
  • Agreement to provide mandatory archival tissue or fresh biopsy.
For a full list of participation criteria, please visit clinicaltrials.gov.
Applicable Disease SitesAny Site
Participating InstitutionsIndiana University (IU)
  • Indiana University Hospital / IU Simon Cancer Center
Treatment TypeTreatment
ContactAnne E. Younger, RNPhone: 317-274-0951
Pager: 317-312-1946
Email: anefoste@iupui.edu