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KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927495
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
The First Affiliated Hospital of Suzhou University
Information provided by (Responsible Party):
Xiaolong Fu, Shanghai Chest Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Drug: KN046 Radiation: palliative radiotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Other Name: Cisplatin+paclitaxel

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.

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.
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.
Other Name: Cisplatin+paclitaxel




Primary Outcome Measures :
  1. dose-limiting toxicity KN046 [ Time Frame: 28 days after first dose ]
  2. 6-month progression free survival rate assessed by investigator based on RECIST 1.1 [ Time Frame: 6 months after first dose ]
  3. Objective response rate assessed by investigator based on RECIST 1.1 [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927495


Contacts
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Contact: Songbing Qin, MD 8651267780081 ext 8651267780081 sdfyec@163.com

Locations
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China
The First Affiliated Hospital of Suzhou University Recruiting
Suzhou, China
Contact: Songbing Qin    8651267780081 ext 8651267780081    sdfyec@163.com   
Sponsors and Collaborators
Shanghai Chest Hospital
The First Affiliated Hospital of Suzhou University
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Responsible Party: Xiaolong Fu, Director, Department of Radiation Oncology, Shanghai Chest Hospital
ClinicalTrials.gov Identifier: NCT03927495    
Other Study ID Numbers: KN046-IST-01
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action