drugset / Trial / NCT06730581

Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

NCT06730581

Phase 2 Not yet recruiting 100 enrolled Beijing Biostar Pharmaceuticals Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-01
Primary completion
2026-12-31
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Epothilone D Small molecule 60 mg/m2
Subject Epothilone D Small molecule 75 mg/m2