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

28 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this trial is to evaluate the safety and tolerability of Utidelone Capsule in patients with advanced solid tumors and determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT). The secondary objectives are to evaluate the pharmacokinetic profile of Utidelone Capsule in patients with advanced solid tumors, preliminarily assess the anti-tumor activity of Utidelone Capsule in patients with advanced solid tumors via objective radiologic tumor response using RECIST 1.1, and to recommend the dose and dosage regimen for subsequent clinical trials.

Research Team

Jacob Thomas, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+