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Poster display session

2496 - PROCLAIM-CX-2009: A First-in-Human Trial to Evaluate CX-2009 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors

Date

11 Sep 2017

Session

Poster display session

Presenters

Javier Garcia-Corbacho

Citation

Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367

Authors

J. Garcia-Corbacho1, A. Spira2, V. Boni3, J. Feliu4, M. Middleton5, H. Burris6, A. Yang Weaver7, M. Will7, J. Harding8, F. Meric-Bernstam9, V. Heinemann10

Author affiliations

  • 1 Oncology, Hospital Clinic Barcelona, 8036 - Barcelona/ES
  • 2 Oncology, Virginia Cancer Specialists Research Institute, and Oncology Research, Fairfax/US
  • 3 Oncology, START Madrid-CIOCC, 28050 - Madrid/ES
  • 4 Oncology, Hospital Universitario La Paz, Madrid/ES
  • 5 Oncology, Oxford NIHR Biomedical Research Centre, University of Oxford, Oxford/GB
  • 6 Oncology, Sarah Cannon Research Institute, Nashville/US
  • 7 Oncology, CytomX Therapeutics, South San Francisco/US
  • 8 Oncology, Memorial Sloan Kettering Cancer Center, New York/US
  • 9 Oncology, University of Texas MD Anderson Cancer Center, Houston/US
  • 10 Oncology, Ludwig-Maximilians-University of Munich - Campus Grosshadern, 81377 - Munich/DE
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Resources

Abstract 2496

Background

CX-2009 is a novel recombinant Probody™ drug conjugate (PDC) derived from a humanized monoclonal antibody (mAb) against CD166 and conjugated to N-succinimidyl 4-(2-pyridyldithio) butanoate-N2′-deacetyl-N2′-(4-mercapto-4-methyl-1-oxopentyl)-maytansine (SPDB-DM4, licensed from Immunogen), a potent microtubule inhibitor. PDCs are fully recombinant mAb prodrugs designed to remain inactive until they are cleaved into an active mAb by tumor-associated proteases. This tumor-specific activation allows PDCs to target highly and homogeneously expressed tumor antigens while avoiding binding to these same targets on healthy tissue. An example is CD166 (also referred to as activated leukocyte cell adhesion molecule [ALCAM]), which is highly expressed in multiple cancers but also in healthy tissue. In preclinical studies, CX-2009 exhibited antitumor activity and reduced peripheral binding compared to the corresponding anti-CD166 ADC.

Trial design

PROCLAIM-CX-2009 (PRObody CLinical Assessment In Man) is an open-label, multicenter, dose-escalation study to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of CX-2009 in 7 selected tumor types with high CD166 expression (breast, lung, prostate, ovarian, endometrial, head and neck, and biliary carcinomas). Part A (n ≤ 50) will initiate with accelerated dose titration, followed by a standard 3 + 3 design to determine the MTD and ending in a modified toxicity probability interval 2-design cohort treated at the MTD to determine the RP2D. Part B of the study will be a dose expansion phase testing CX-2009 administered at the RP2D in the same 7 tumor types (up to 14 patients each, n ≤ 98). Eligibility is based on confirmed refractory metastatic or locally advanced unresectable tumor. Outcome measures include assessment of safety, tolerability, pharmacokinetics, and efficacy based on RECIST 1.1. Exploratory biomarkers will characterize tumor CD166 expression and mitotic markers as well as CX-2009 activation in tumor versus peripheral blood.

Clinical trial identification

NCT03149549

Legal entity responsible for the study

CytomX Therapeutics, South San Francisco, CA, USA

Funding

CytomX Therapeutics, South San Francisco, CA, USA

Disclosure

M. Middleton: Grants: Roche, AstraZeneca, GSK. Advisory board: Amgen, Novartis, Rigontec, CytomX. Personal fees: Amgen, Roche, GSK, Novartis, Bristol-Myers Squibb, Eisai, Merck, CytomX. A. Yang Weaver, M. Will: Employee of CytomX Therapeutics. J. Harding: Consultant to Bristol-Myers Squibb. All other authors have declared no conflicts of interest.

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