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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

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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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