Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Z650 · 1 trial · 1 indication
AEs assessment via monitoring changes in vital signs (e.g.body temperature, pulse rate, blood pressure, respiratory rate,etc.) and physical examinations(e.g.height, weight, BMI,etc.)
| Arm | Type | Description |
|---|---|---|
| Z650 , Single-arm | EXPERIMENTAL | Z650 will be administered daily, at dose of 350 mg orally |
| Name | Type | Description |
|---|---|---|
| Z650 | DRUG | receive oral Z650 once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days |
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 ...
Z650 is an investigational small molecule being developed for the treatment of Esophageal Squamous Cell Carcinoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Z650 targets EGFR, the epidermal growth factor receptor. It is being studied in patients with advanced Esophageal Squamous Cell Carcinoma who have EGFR overexpression or gene amplification.
Z650 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company. The company's stock trades under the ticker symbol SBFM.
Z650 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use. The Phase 1 trial has been completed.
Z650 has one completed Phase 1 clinical trial, NCT03888092, which studied the drug in advanced Esophageal Squamous Cell Carcinoma with EGFR overexpression or gene amplification. The trial enrolled 81 participants in China.
Z650 is the primary name for this investigational drug. No alternative names have been reported for this compound.