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Clinical Trials

Date: 2017-05-17

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago

Company: CytomX Therapeutics (USA - CA)

Product: CX-072 in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib)

Action mechanism: immune checkpoint inhibitor.

Disease: solid tumors, lymphoma

Therapeutic area: Cancer - Oncology

Country: USA

Trial details: The PROCLAIM-072 Trial s an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib) in patients with all types of cancers. 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. This is the first clinical trial under the international umbrella program, PROCLAIM. (NCT03013491)

Latest news:

  • • On May 17, 2017, CytomX Therapeutics announced an upcoming poster presentation for its lead product candidate, CX-072, a PD-L1 targeting Probody therapeutic for the treatment of cancer, at the American Society of Clinical Oncology Annual Meeting from June 2-6, 2017 in Chicago, Illinois. This poster presentation at ASCO will review the design and objectives of the ongoing PROCLAIM-CX-072 study.” As part of the study, CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial:
  • Tolerability: Demonstrate that CX-072 is well tolerated in patients and potentially improves safety, particularly in the combination setting.
  • Anti-cancer activity: Demonstrate initial evidence of CX-072’s anti-cancer activity as monotherapy and in combination.
  • Translational program and Probody platform proof-of-concept: Explore mechanistic aspects of Probody activity in patients as observed in preclinical studies. • On February 2, 2017, CytomX Therapeutics announced the treatment of the first patient in the PROCLAIM (Probody Clinical Assessment In Man) CX-072 study, a Phase 1/2 clinical trial evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib) in patients with all types of cancers.
  • • On December 14, 2016, CytomX Therapeutics announced that the FDA has cleared the company’s Investigational New Drug (IND) application for CX-072. The company plans to immediately initiate the study and open clinical sites to support patient enrollment. PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics. The first module to be initiated is the PROCLAIM-072 clinical study, an open-label, dose-finding phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. Clinical data from PROCLAIM-072 is expected to begin to emerge in late 2017 and throughout 2018.
 

Is general: Yes