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390 COM701 (a novel immune checkpoint inhibitor) in patients with advanced solid tumors
  1. A Elnaggar1,
  2. J Luke2,
  3. E Hamilton3,
  4. B Chmielowski4,
  5. E Ileana-Dumbrava5,
  6. A Patnaik6,
  7. E Lim7,
  8. A Adewoye8,
  9. J Hunter9,
  10. J Olweny8,
  11. M Sharma10,
  12. R Sullivan11,
  13. D Vaena12 and
  14. D Rasco6
  1. 1West Cancer Center., Gynecologic Oncology., Memphis- TN., USA
  2. 2University of Chicago., Medical Oncology., Chicago-IL., USA
  3. 3Sarah Cannon Research Institute., Medical Oncology., Nashville- TN., USA
  4. 4University of California Los Angeles., Medical Oncology, Los Angeles- CA., USA
  5. 5The University of Texas MD Anderson Cancer Center., Department of Investigational Cancer Therapeutics., Houston- TX., USA
  6. 6South Texas Accelerated Research Therapeutics START., Medical Oncology., San Antonio- TX., USA
  7. 7Columbia University., Medical Oncology., New York- NY., USA
  8. 8Compugen USA Inc., Clinical Development., South San Francisco, USA
  9. 9Compugen USA Inc., Research and Development., South San Francisco, USA
  10. 10START Midwest., Medical Oncology., Grand Rapids- MI., USA
  11. 11Massachusetts General Hospital., Medical Oncology., Boston- MA., USA
  12. 12West Cancer Center., Director of Phase 1 Research, Memphis- TN., USA


Objectives Novel therapies are needed for the treatment of pts with relapse/refractory disease following treatment with approved checkpoint inhibitors. COM701 is a 1st in class novel immune checkpoint inhibitor of PVRIG, part of the DNAM axis. Key primary objectives/endpoints: safety and tolerability of COM701 monotherapy and in combination with nivolumab (doublet), measured by the incidence of pts with adverse events (AEs) and dose-limiting toxicities (DLTs). The recommended dose for expansion of COM701 monotherapy and in combination with nivolumab. Key secondary objectives/endpoints: the preliminary antitumor activity of COM701 monotherapy and doublet in pts with selected tumor types (endometrial, ovarian, breast and lung cancer).

Methods Study design: dose escalation hybrid single subject accelerated titration design and 3+3 design. Key inclusion criteria: Age ≥18 yrs, histologically confirmed, advanced solid tumor and has exhausted all available standard therapy or not a candidate for available standard therapy, prior checkpoint inhibitor permissible. Key exclusion criteria: inflammatory pneumonitis, history of immune-related events that led to immunotherapy treatment discontinuation. We report on COM701 monotherapy dose escalation. Expansion cohorts will enroll pts with the selected tumor types (above). Identifier: NCT03667716.

Results At time of this submission no DLTs observed up to 5th COM701 monotherapy dose level pt cohort.

Conclusions Study enrollment ongoing.

COM701 monotherapy safe and tolerable at the doses tested. Updated results will be presented at the meeting.

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