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Utidelone Capsule Monotherapy for Patients with Advanced Solid Tumors

NCT06730581 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-12-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Beijing Biostar Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06730581 on ClinicalTrials.gov