KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KN046
palliative radiotherapy
KN046
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma
Eligibility 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
Sites / Locations
- The First Affiliated Hospital of Suzhou UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Concurrent chemoradiotherapy and KN046
chemoradiotherapy and sequential KN046
Arm Description
Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Outcomes
Primary Outcome Measures
dose-limiting toxicity KN046
6-month progression free survival rate assessed by investigator based on RECIST 1.1
Objective response rate assessed by investigator based on RECIST 1.1
Secondary Outcome Measures
Full Information
NCT ID
NCT03927495
First Posted
April 23, 2019
Last Updated
May 27, 2019
Sponsor
Shanghai Chest Hospital
Collaborators
First Affiliated Hospital of Suzhou Medical College
1. Study Identification
Unique Protocol Identification Number
NCT03927495
Brief Title
KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Official Title
Phase II Study of KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma to Evaluate Safety, Efficacy and Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 22, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
Collaborators
First Affiliated Hospital of Suzhou Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Concurrent chemoradiotherapy and KN046
Arm Type
Experimental
Arm Description
Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Arm Title
chemoradiotherapy and sequential KN046
Arm Type
Experimental
Arm Description
Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
KN046
Other Intervention Name(s)
Cisplatin+paclitaxel
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
palliative radiotherapy
Intervention Description
3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
Intervention Type
Drug
Intervention Name(s)
KN046
Other Intervention Name(s)
Cisplatin+paclitaxel
Intervention Description
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.
Primary Outcome Measure Information:
Title
dose-limiting toxicity KN046
Time Frame
28 days after first dose
Title
6-month progression free survival rate assessed by investigator based on RECIST 1.1
Time Frame
6 months after first dose
Title
Objective response rate assessed by investigator based on RECIST 1.1
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songbing Qin, MD
Phone
8651267780081
Ext
8651267780081
Email
sdfyec@163.com
Facility Information:
Facility Name
The First Affiliated Hospital of Suzhou University
City
Suzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Songbing Qin
Phone
8651267780081
Ext
8651267780081
Email
sdfyec@163.com
12. IPD Sharing Statement
Learn more about this trial
KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
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