Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Larotinib, Lerotinib
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 being studied for the treatment of advanced esophageal squamous cell carcinoma, a type of esophageal cancer. It is an investigational small molecule developed by Sunshine Biopharma Inc. The clinical program has focused on patients whose tumors show EGFR over expression or gene amplification, meaning the therapy is aimed at a biomarker-selected population.
Z650 is being developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor of the clinical program for this small molecule in oncology.
Z650 is in Phase 1 clinical development. It is an investigational drug and is not approved for commercial use. The Phase 1 study in advanced esophageal squamous cell carcinoma has been completed, and no trials for Z650 are currently listed as active.
Z650 has been evaluated in one clinical trial, NCT03888092, titled Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification. The Phase 1 study enrolled 81 patients in China, was uncontrolled and non-randomized, and is now completed.
Yes. The Z650 Phase 1 trial, NCT03888092, specifically enrolled patients with advanced esophageal squamous cell carcinoma whose tumors had EGFR over expression or gene amplification. This biomarker-selected design means study participants were chosen based on the presence of these EGFR features.