KN046 in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Phase 2
- Conditions
- Esophageal Squamous Cell Carcinoma
- Interventions
- Radiation: palliative radiotherapy
- Registration Number
- NCT03927495
- Lead Sponsor
- Shanghai Chest Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Concurrent chemoradiotherapy and KN046 palliative radiotherapy Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. chemoradiotherapy and sequential KN046 palliative radiotherapy Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. Concurrent chemoradiotherapy and KN046 KN046 Participants in the Arm I will receive chemoradiotherapy and concurrent KN046. Radiotherapy will be completed within the four-cycle of chemotherapy. chemoradiotherapy and sequential KN046 KN046 Participants in the Arm II will receive chemoradiotherapy and sequential KN046. Radiotherapy will be completed within the four-cycle of chemotherapy.
- Primary Outcome Measures
Name Time Method dose-limiting toxicity KN046 28 days after first dose 6-month progression free survival rate assessed by investigator based on RECIST 1.1 6 months after first dose Objective response rate assessed by investigator based on RECIST 1.1 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The First Affiliated Hospital of Suzhou University
🇨🇳Suzhou, China