Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification

• Status: Active, not recruiting
• Trial end date: 2021-06-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunshine Lake Pharma Co., Ltd.

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed Stage IIIB or IV ESCC

• At least experienced one regimens of chemotherapy prior to study

• Histological or cytological evidence of EGFR overexpression or gene copy number increased

• Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1)

• Toxicity recovered to NCI CTCAE v.4.03 Grade ≤1 from previous treatments (except alopecia)

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

• Life expectancy of ≥ 12 weeks

• Adequate organ function

• Subject Consent

• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to performing this study.

• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

• Prior treatments

• EGFR targeted therapy, or major surgery within 4 weeks prior to study treatment

• Nitrosourea and mitomycin chemotherapy within 6 weeks prior to study treatment

• Had received any investigational agent from other clinical study within 4 weeks prior to study treatment or are currently participating in other clinical trials

• Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction);

• Symptomatic, untreated or unstable central nervous system metastases (patient are only permitted if treated, asymptomatic and stable for at least 4 weeks prior to start of study treatment)

• History of interstitial lung disease

• Uncontrolled hypertension that require more than two anti-hypertensive agents to control, or systolic blood pressure (BP) >140mmHg or diastolic BP >90 mmHg before the first administration

• Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%

• Male with QTc interval > 450 ms or female with QTc interval > 470 ms

• History of immunodeficiency, or other acquired or congenital immunodeficiency, or history of organ transplantation

• Any disease of the following bellowed within 6 months prior to administration:

Myocardial infarction, or unstable angina, coronary or peripheral artery bypass graft, congestive heart failure, or cerebrovascular events (including transient ischemic attack)

• Active infection of hepatitis B virus (HBV)/hepatitis C virus (HCV), or infection of Human immunodeficiency virus (HIV)

• Other malignancies within 5 years prior to enrollment, with the exception of carcinoma in situ of the cervix, basal or squamous cell skin cancer

• History of serious allergic reactions attributed to excipients of Z650, including mannitol, sodium carboxymethyl starch, aerosol, magnesium stearate and silicified microcrystalline cellulose

• Pregnant women, or patients not agree to use of effective contraceptions during the study or within 6 month after the study

• Any other reason the investigator considers the patient is not suitable to participate in the study