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A First-in-Human Study of a Novel Monoclonal Antibody INCSHR01210 Directed Against Programmed Cell Death Protein 1 (PD-1) in Patients with Advanced or Metastatic Cancer

Date

10 Sep 2017

Session

Poster display session

Presenters

Jason Lickliter

Citation

Annals of Oncology (2017) 28 (suppl_5): v403-v427. 10.1093/annonc/mdx376

Authors

J. Lickliter1, H. Gan2, B. Gao3, P. Grimison4, J. Zou5, H. Kallender6, K. Sun6, X. Chen6, A. Behren2, P. Fernandez-Penas7, A. Nagrial8, M. Voskoboynik1, K. Woods9, M. Millward10, T. Meniawy10

Author affiliations

  • 1 Oncology, Nucleus Network, 3004 - Melbourne/AU
  • 2 Oncology, Austin Hospital/Olivia Newton-John Cancer Research Institute, Heidelberg/AU
  • 3 Oncology, Blacktown Hospital, 2148 - Blacktown/AU
  • 4 Oncology, Chris O’Brien Life House, Camperdown/AU
  • 5 Oncology, Jiangsu Hengrui Medicine Co.,Ltd., Shanghai/CN
  • 6 Oncology, Incyte Corporation, 19803 - Wilmington/US
  • 7 Oncology, The University of Sydney, Camperdown/AU
  • 8 Oncology, Blacktown Hospital, Blacktown/AU
  • 9 Cancer Immunobiology, Austin Hospital/Olivia Newton-John Cancer Research Institute, Heidelberg/AU
  • 10 Oncology, Linear Clinical Research Limited, Nedlands/AU
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Resources

Background

INCSHR01210 is a novel PD-1 inhibitor with a safety and activity profile that may be different from that of other PD-1 inhibitors.

Methods

This is an ongoing, open-label, Phase1, dose-escalation/tumor-expansion study to evaluate the safety of INCSHR01210 in patients (pts) with relapsed/refractory solid tumors (NCT02492789). In Part 1, INCSHR01210 was administered IV at 1, 3, 6, or 10 mg/kg, initially on Day 1 of a 28-day cycle (for safety, PK and PD) and then Q2W, in a standard 3 + 3 dose-escalation design. Based on Part 1 data, Part 2 consisted of different tumor expansion cohorts, in which fixed doses of INCSHR01210 (600 mg and 200 mg Q4W) were evaluated.

Results

As of data cutoff (3Feb2017), 23 pts were treated in Part 1 (median age, 62 y [range, 32–73]; 74% women). Treatment-related AEs in ≥ 20% of pts (all Gr; Gr3/4) were skin capillary hemangioma (61%; 0%) and diarrhea (26%; 4%). Skin capillary hemangiomas were scattered and typically:

Conclusions

INCSHR01210 demonstrated manageable toxicity, but with Gr1/2 hemangioma not seen with prior PD-1 inhibitors. The recommended Phase 2 dose/schedule is 200 mg Q4W.

Clinical trial identification

NCT02492789

Legal entity responsible for the study

Incyte Europe Sàrl, Geneva, Switzerland

Funding

Incyte Europe Sàrl, Geneva, Switzerland

Disclosure

P. Grimison: Corporate-sponsored research: Tilray, Incyte, Gilead, Tigermed, Pfizer, Merck, Boston Biomedical, Medimmune, Halozyme, Specialised Therapeutics Australia. H. Kallender, K. Sun, X. Chen: Employee at Incyte Corporation. A. Behren: CSL Ltd: Stock ownership, Corporate-sponsored research. P. Fernandez-Penas: Advisory board member: Roche, Janssen, Abbvie, Lilly, Novartis Employee: The University of Sydney, Westmead Hospital Corporate-sponsored research: Incyte. K. Woods: Corporate-sponsored research: CSL Ltd. All other authors have declared no conflicts of interest.

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