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.
A Pivotal Phase II Clinical Trial of Utidelone Injection (UTD1) Plus Capecitabine (CAP) in HER2-negative Breast Cancer Patients with Brain Metastases
Clinical trial information
Our company is currently conducting a clinical trial to evaluate the tolerability of utidelone injection (UTD1) plus capecitabine (CAP) in HER2-negative breast cancer patients with brain metastases. This study is a multicenter, two-stage clinical study. A total of 120 participants with HER2-negative breast cancer with brain metastases will be enrolled. The primary objective of this study is to evaluate the intracranial objective response rate (IC-ORR). The secondary objective includes: to evaluate the IC-ORR, ORR, progression free survival (PFS), disease control rate (DCR), duration of response (DOR), IC-PFS, IC-DCR, IC-DOR, overall survival (OS), safety, and pharmacokinetic characteristics.
Main inclusion criterion
· Male or female aged ≥18 years
· Have histologically confirmed HER2-negative metastatic breast cancer. HER2-negative defined as immunohistochemical (IHC) score of 0 or 1+, or IHC2+ with negative HER2 expression on in situ hybridization (ISH)
· Based on screening contrast-enhanced brain MRI, patients must have at least one measurable intracranial lesion according to RECIST 1.1 (≥1.0 cm in size) and must have one of the following:
Untreated brain metastases not needing immediate local therapy.
Brain metastases progressing after prior local therapy
· ≤ 3 prior lines of chemotherapy in advanced or metastatic setting.
A Multi-national, Open-label, Randomized Phase II/III Clinical Study of Utidelone Capsule (UTD2) Combined with Capecitabine and Oxaliplatin in First-line Treatment of Patients with PD-L1-negative Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Clinical trial information
Our company is currently conducting a clinical trial to evaluate the efficacy and safety of UTD2 combined with capecitabine and oxaliplatin in patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This is a multi-national, open-label, randomized, phase II/III clinical study. Approximately 778 participants will be enrolled in the study. 78 participants will be enrolled in phase II and 700 participants will be recruited in phase III.
In phase II, the primary objective is to evaluate and confirm the doses of UTD2 and capecitabine in combination with oxaliplatin. The secondary objective includes: to evaluate the objective response rate (ORR), safety and pharmacokinetic characteristics.
In phase III, the primary objective is to evaluate the overall survival (OS), The secondary objective includes: to evaluate the progression free survival (PFS), objective response rate (ORR), safety and pharmacokinetic characteristics.
Main inclusion criterion
· Male or female aged ≥18 years
· Have unresectable, advanced or metastatic GC or GEJ and have histologically/pathologic confirmed predominant adenocarcinoma.
· PD-L1 Combined Positive Score (CPS) < 1.
· Her2 negative.
· Have at least one measurable lesion per RECIST 1.1.
· No previous systemic treatment in the advanced setting.