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Poster Discussion session - Immunotherapy of cancer 2

1456 - Phase I Study of KN035, a novel fusion Anti-PD-L1 Antibody administered subcutaneously in Patients with Advanced Solid Tumors in the USA


22 Oct 2018


Poster Discussion session - Immunotherapy of cancer 2


Clinical Research;  Immunotherapy

Tumour Site


Kyri Papadopoulos


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


K.P. Papadopoulos1, W. Harb2, N. Lu3, X. Ma4, Y. He3, L. Yuan4, M. Fu5, Y. Lin6, W. Xu7, X. Wang8, P. Wang9, T. Xu10, R. Dong11, J. Gong12

Author affiliations

  • 1 Clinical research Department, South Texas Accelerated Research Therapeutics (START), 78229 - San Antonio/US
  • 2 Horizon Oncology Research, Llc., Horizon BioAdvance, 47905 - Lafayette/US
  • 3 Clinical Operation Department, 3D Medicines Co., Ltd., 100176 - Beijing/CN
  • 4 Medical Affairs Department, 3D Medicines Co., Ltd., 201114 - Shanghai/CN
  • 5 Clinical Operation Department, 3D Medicines Co., Ltd., 20854 - Potomac, MD/US
  • 6 Preclinical Research Department, 3D Medicines Co., Ltd., 201114 - Shanghai/CN
  • 7 Research & Development, 3D Medicines Co., Ltd., 100176 - Beijing/CN
  • 8 Department Of Early Discovery, Suzhou Alphamab Co., Ltd., 215125 - Suzhou/CN
  • 9 Department Of Pharmacology, Suzhou Alphamab Co., Ltd., 215125 - Suzhou/CN
  • 10 -, Suzhou Alphamab Co., Ltd., 215125 - Suzhou/CN
  • 11 Medical Affairs Department, 3D Medicines Co., Ltd., Shanghai/CN
  • 12 -, 3D Medicines Co., Ltd., Shanghai/CN

Abstract 1456


KN035 is a novel fusion protein of anti-PD-L1 single domain antibody and Fc, formulated for subcutaneous (SC) injection. A phase 1 dose escalation study was performed in the USA to evaluate and characterize the safety and tolerability, MTD, PK, PD and preliminary antitumor activity of single agent KN035 in patients (pts) with locally advanced or metastatic solid tumors.


A modified 3 + 3 dose-escalation design was adopted with the DLT evaluation period of 28 days after the first dose of KN035, with 8 dose levels planned at 0.01, 0.03, 0.1, 0.3, 1.0, 2.5, 5 and 10 mg/kg SC weekly. Single patient cohorts were planned at the dose levels of 0.01, 0.03 and 0.1 mg/kg/dose; unless a ≥ G2 drug-related AE occurred in the first 28-day cycle, then 2 additional pts would be enrolled. Response was evaluated by RECIST 1.1 every 12 weeks.


As of May 4, 2018, a total of 18 pts have been enrolled (including prostate cancer [n = 5], non-small cell lung cancer (NSCLC) [n = 2], breast cancer [n = 2], gastrointestinal cancers [n = 5], melanoma, cervical, head and neck and bladder cancer). Planned maximum dose of 10 mg/kg has been administered (n = 3) without DLT. Most common treatment-related AEs were G1/2 (61.1%). Adverse Events experienced by more than 1 patient were fatigue (n = 4, 22%), aspartate aminotransferase increased, alanine aminotransferase increased and nausea (each n = 2, 11%). The only treatment–related G3 AE was lymphopenia (n = 1), which occurred at 0.1 mg/kg and resolved one week later despite continued dosing. Overall, the emergence of AEs was not dose-related. The exposure to KN035 was dose-dependent and increased proportionally. Average half-life (t1/2) of KN035 was approximately 200 hours. Among 13 evaluable pts, 2 pts had confirmed PR, including 1 NSCLC pt at 0.3mg/kg (response duration 9 months) and 1 MSI-H prostate cancer pt at 2.5mg/kg (ongoing response 5 months), and 5 pts achieved SD.


KN035 exhibits a favorable safety profile in patients with advanced malignancies and preliminary results demonstrate encouraging anti-tumor activity.

Clinical trial identification

Protocol Number: KN035-US-001, NCT02827968.

Legal entity responsible for the study

3D Medicines (Sichuan) Co., Ltd.


3D Medicines (Sichuan) Co., Ltd.

Editorial Acknowledgement


W. Harb: Consulting for advisory role (Institution/Self): Boston Biomedical, Pfizer, Vigeo. R. Dong: CMO: 3D Medicines (Sichuan) Co., Ltd; Advisor: Newbay Biopharma; CEO: Haihe Biopharma. J. Gong: Independent board of directors: Staidson (Beijing) Biopharmaceuticals Co., Ltd, Shandong Jincheng Pharmaceutical Group Co., Ltd. And Accendatech Co, Ltd. All other authors have declared no conflicts of interest.

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