R&D
Clinical Recruitment
Biostar is currently conducting several clinical trials, which are open recruiting.
Note: The above recruitment information only lists the main inclusion criteria for the trial. If you meet the above main inclusion criteria and wish to participate in the trial, with your written consent, you will be required to take a medical history inquiry, physical examination, laboratory examination, imaging evaluation (CT/MRI), etc., which will be paid by our company. If, after assessment, you meet all relevant criteria in the study protocol, you may participate in the study.
If you want to enroll in the clinical trial, you have the right to consult the relevant information during the medication period and the right to withdraw from this study at any time, and your privacy will be protected.
Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients with Advanced Solid Tumors
Clinical trial information
Our company is currently conducting a clinical trial to evaluate the tolerability of Utidelone Capsule (UTD2) in patients with advanced solid tumors. This study is an open-label phase I dose escalation study. Up to 28 participants with solid tumors will be enrolled. The primary objective of this study is to evaluate the safety and tolerability of UTD2 in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objective includes: to evaluate the pharmacokinetic profile of UTD2 in patients with advanced solid tumors; to preliminarily assess the anti-tumor activity of UTD2 in patients with advanced solid tumors; to recommend the dose and dosage regimen for subsequent clinical trials.
Main inclusion criterion
- Patients with histologic or pathologic documentation of incurable, locally advanced, or metastatic solid tumors for which standard therapies are not available, no longer effective, and not tolerated, and for those patients who have declined the standard therapies;
- Male or female subjects aged ≥18, with ECOG performance status scored 0–1;
- Expected survival time ≥ 12 weeks;