KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

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.

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