NCT06730581

Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

Phase II Clinical Trial of Utidelone Capsule in the Treatment of Advanced Solid Tumor Patients

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beijing Biostar Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with advanced solid tumors. The target population of the study is patients with advanced solid tumors (gastric cancer, ovarian cancer, cholangiocarcinoma and other tumors (esophageal cancer, hepatocellular carcinoma, colorectal cancer, cervical cancer). The number of evaluable cases for tumor enrollment in gastric, ovarian, and bile duct cancers will be 20 cases each, and the total number of other tumors (including esophageal, liver, colorectal, and cervical cancers) will be no more than 40 cases. Patients who met the enrollment criteria received Utidelone capsule (UTD2) monotherapy.

Conditions

• Gastric Cancer Adenocarcinoma Metastatic
• Ovarian Cancer
• Bile Duct Cancer

Interventions

Type	Name	Description
DRUG	Utidelone Capsule 60mg/m2/d	60mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
DRUG	Utidelone capsule 75mg/m2	75mg/m2/d, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
DRUG	Utidelone Capsule	Dosing regimens were determined based on the results of gastric and ovarian cancer dosing regimens.D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-12
• Last updated: 2024-12-12