KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Overview

This is an open-label, phase II study of KN046 combined with chemotherapy and palliative radiotherapy in patients with recurrent or metastatic esophageal squamous cell carcinoma to evaluate the safety, efficacy and tolerance.

Full Title of Study: “Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2021

Interventions

  • Drug: KN046
    • Cisplatin+paclitaxel will be administered once every three weeks for four cycles. During the period of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.
  • Radiation: palliative radiotherapy
    • 3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
  • Drug: KN046
    • Cisplatin+paclitaxel will be administered once every three weeks for four cycles. After completion of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.

Arms, Groups and Cohorts

  • Experimental: Concurrent chemoradiotherapy and KN046
    • Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
  • Experimental: chemoradiotherapy and sequential KN046
    • Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.

Clinical Trial Outcome Measures

Primary Measures

  • dose-limiting toxicity KN046
    • Time Frame: 28 days after first dose
  • 6-month progression free survival rate assessed by investigator based on RECIST 1.1
    • Time Frame: 6 months after first dose
  • Objective response rate assessed by investigator based on RECIST 1.1
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Signed inform consent form(ICF) – Age ≥ 18 years and ≤ 75 years, male or female – Histologically or cytologically documented recurrent or metastatic esophageal squamous cell carcinoma, with indications of radiotherapy and without prior systemic treatment – At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1 – Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 – Adequate organ function – Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. – Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures Exclusion Criteria:

  • Known brain metastasis or another Central Nervous System (CNS) metastasis that is either symptomatic or untreated. – Patients who are participating or have participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment. – Patients who have received immune checkpoint proteins/antibody/medicine for treatment. – Patients who have interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management. – Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded – Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection. – Known HIV infection or known history of acquired immune deficient syndrome (AIDS) – Any unresolved the Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 toxicities from prior anti-cancer therapy except for vitiligo, alopecia – Patients who have serious hypersensitive reaction to monoclonal antibodies and have history of uncontrolled allergic asthma

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai Chest Hospital
  • Collaborator
    • First Affiliated Hospital of Suzhou Medical College
  • Provider of Information About this Clinical Study
    • Principal Investigator: Xiaolong Fu, Director, Department of Radiation Oncology – Shanghai Chest Hospital
  • Overall Contact(s)
    • Songbing Qin, MD, 8651267780081, sdfyec@163.com

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