KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

May 27, 2019 updated by: Xiaolong Fu, Shanghai Chest Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Songbing Qin, MD
  • Phone Number: 8651267780081 8651267780081
  • Email: sdfyec@163.com

Study Locations

  • China
      • Suzhou, China
        • Recruiting
        • The first affiliated hospital of suzhou University
        • Contact:
          • Songbing Qin
          • Phone Number: 8651267780081 8651267780081
          • Email: sdfyec@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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 Names:
  • Cisplatin+paclitaxel
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.
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 Names:
  • 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.
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 Names:
  • Cisplatin+paclitaxel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
dose-limiting toxicity KN046
Time Frame: 28 days after first dose
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
6 months after first dose
Objective response rate assessed by investigator based on RECIST 1.1
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Chest Hospital

Collaborators

First Affiliated Hospital of Suzhou Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 22, 2019

Primary Completion (ANTICIPATED)

June 30, 2021

Study Completion (ANTICIPATED)

December 31, 2021

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (ACTUAL)

April 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2019

Last Update Submitted That Met QC Criteria

May 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KN046-IST-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Esophageal Squamous Cell Carcinoma

Clinical Trials on KN046

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe