KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Chest Hospital
• Collaborators: First Affiliated Hospital of Suzhou Medical College; The First Affiliated Hospital of Suzhou University
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

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