Utidelone Capsules for Advanced Cancer

Overseen By RONGGUO QIU, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Biostar Pharma, Inc.

Must not be taking: Corticosteroids

Disqualifiers: Brain metastasis, Heart failure, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

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. ^{1 2 3 4 5}

Why 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. ^{1 4 5 6 7}

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

I am 18 or older and mostly active without needing to stay in bed.

Willing and able to sign a written informed consent

Expected survival time ≥ 12 weeks

Exclusion Criteria

I haven't had specific health issues in the last 6 months.

Patients with hypersensitivity reaction caused by previous anti-microtubule drugs

Patients with baseline QTc interval > 470 msec

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Utidelone Capsule in various dose cohorts for 5 to 7 consecutive days in a 21-day cycle

12 months

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?

Group I: Utidelone Capsule at 75 mg/m2/d for 5 days Experimental Treatment 1 Intervention

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.

Group II: Utidelone Capsule at 50 mg/m2/d for 5 days Experimental Treatment 1 Intervention

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.

Group III: Utidelone Capsule at 25 mg/m2/d for 5 days Experimental Treatment 1 Intervention

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.

Group IV: Utidelone Capsule at 120 mg/m2/d for 7 days Experimental Treatment 1 Intervention

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.

Group V: Utidelone Capsule at 100 mg/m2/d for 7 days Experimental Treatment 1 Intervention

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.

Group VI: Utidelone Capsule at 100 mg/m2/d for 5 days Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Biostar Pharma, Inc.

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3030

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07044349

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.

3. firstwordpharma.com firstwordpharma.com/story/6072854

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 ...

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e13115

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.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38601485/

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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06730581

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 ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e13110

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 ...