KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03927495
• Other study ID #: KN046-IST-01
• Status: Recruiting
• Phase: Phase 2
• Start date: May 22, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2019
• Source: Shanghai Chest Hospital
• Contact: Songbing Qin, MD
• Phone: 8651267780081
• Email: sdfyec[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Suzhou University	Suzhou

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Chest Hospital	The First Affiliated Hospital of Suzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose-limiting toxicity KN046		28 days after first dose
Primary	6-month progression free survival rate assessed by investigator based on RECIST 1.1		6 months after first dose
Primary	Objective response rate assessed by investigator based on RECIST 1.1		2 years