Utidelone Capsules for Advanced Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the safety and tolerability of Utidelone Capsules in individuals with advanced solid tumors, which are cancers that have spread or cannot be cured by standard treatments. Researchers are examining how the body processes the drug and whether it can shrink tumors. Participants will receive varying doses of Utidelone to determine the optimal amount for future studies. This trial may suit those with advanced cancers who have not found success with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you cannot have received certain anti-tumor therapies like chemotherapy or radiotherapy within 2 weeks before starting the trial.
Is there any evidence suggesting that Utidelone Capsule is likely to be safe for humans?
Research has shown that Utidelone, a capsule treatment for advanced solid tumors, has undergone previous study. In those studies, patients generally tolerated the treatment well, with manageable side effects. Common side effects included tiredness and nausea, typical of many cancer treatments.
Utidelone has approval in China for treating advanced breast cancer, providing some confidence in its safety for humans. However, this trial aims to determine the highest dose people can take without serious side effects. While researchers continue to test the capsule form, the injectable version has been used safely in other studies.
Prospective participants should know that, despite existing safety data, the trial seeks to learn more about how people handle different doses.12345Why do researchers think this study treatment might be promising?
Researchers are excited about Utidelone Capsules for advanced cancer because they offer a new approach to treatment. Unlike traditional chemotherapy agents, Utidelone is a synthetic analog of epothilone, which works by stabilizing microtubules, disrupting cancer cell division. This unique mechanism could potentially overcome resistance seen with other chemotherapies like taxanes and anthracyclines. Additionally, the flexibility in dosage and treatment schedule in different cohorts allows for optimization of efficacy and tolerability, which is not typically seen with standard treatments.
What evidence suggests that this trial's treatments could be effective for advanced cancer?
Research shows that Utidelone, a new treatment under study in this trial, holds promise for advanced cancers. Studies on similar versions of Utidelone have shown positive effects in cancers such as stomach and breast cancer. Patients using Utidelone have experienced improvements in their conditions. The drug stops cancer cells from growing, which might explain its potential benefits. Although more information is needed, early results are encouraging.14567
Who Is on the Research Team?
Jacob Thomas, MD
Principal Investigator
University of Southern California
Are You a Good Fit for This Trial?
This trial is for adults over 18 with advanced solid tumors that can't be cured and have no effective standard treatments left. They must be relatively healthy (ECOG score 0-1), expect to live at least 12 weeks, and have normal liver function tests, blood cell counts within certain limits, and agree to informed consent.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Utidelone Capsule in various dose cohorts for 5 to 7 consecutive days in a 21-day cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Utidelone Capsule
Trial Overview
The trial is testing Utidelone Capsule's safety in patients with advanced solid tumors. It aims to find the highest dose patients can take without severe side effects (MTD) and identify any major toxic reactions (DLT). The study will also look into how the body processes the drug, its potential anti-tumor effects, and suggest dosing for future trials.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
Cohort 3: 3-6 subjects are planned to take Utidelone Capsule at 75 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.
Cohort 2: 2 subjects are planned to take Utidelone Capsule at 50 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.
Cohort 1: 2 subjects are planned to take Utidelone Capsule at 25 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.
Cohort 6: 3-6 subjects are planned to take Utidelone Capsule at 120 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.
Cohort 5: 3-6 subjects are planned to take Utidelone Capsule at 100 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.
Cohort 4: 3-6 subjects are planned to take Utidelone Capsule at 100 mg/m2/d by QD for 5 consecutive days in a 21-day cycle.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biostar Pharma, Inc.
Lead Sponsor
Citations
Efficacy and safety results of a multi-center phase I study ...
Utidelone capsule (UTD2) can significantly improve medication compliance and the convenience of clinical application. This is the first-in-human ...
NCT07044349 | Phase II Clinical Study of Utidelone ...
Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
Biostar Pharma Successively Achieved First Patient Dosing ...
Utidelone has demonstrated excellent clinical data in gastric cancer: in a completed Phase II study of Utidelone Injection (UTD1) combined ...
A clinical study of utidelone capsule for advanced breast ...
This is the first clinical study in China to investigate the efficacy and safety of UTD2 monotherapy for treatment of advanced breast cancer.
Efficacy and safety of utidelone for the treatment of patients ...
The aim of this open-label, multicenter phase 2 clinical trial was to determine the efficacy and safety of utidelone, a novel genetically engineered epothilone ...
Utidelone Capsule Monotherapy for Patients with ...
This trial is an open, multicenter, phase II clinical trial to evaluate the efficacy and safety of Utidelone capsules in patients with ...
Effcacy and safety results of a multi-center phase I/II study ...
Utidelone injection (UTD1) has been approved for advanced breast cancer (BC) in China. Attempts to develop oral microtubule inhibitors have not ...
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