Advanced Solid TumorPhase 1NCT05681000
Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors
A Phase 1 study testing Utidelone Capsule in people with Advanced Solid Tumor, run by Biostar Pharma, Inc. at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Utidelone Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to sign a written informed consent;
- Patients with histologic or pathologic documentation of incurable, locally advanced, or metastatic solid tumors for which standard therapies are not available, no longer effective, and not tolerated, and for those patients who have declined the standard therapies;
- Male or female subjects aged ≥18, with ECOG performance status scored 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate organ and marrow function as defined below:
- neutrophil count (ANC) ≥ 1.5 × 109/L
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- platelet count (PLT) ≥ 100 × 109/L
- hemoglobin ≥ 9 g/dL
- total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
- alanine transaminase (ALT) ≤ 2.5 × ULN
- aspartate transaminase (AST) ≤ 2.5 × ULN
- Creatinine clearance ≥ 60 mL/min
- Female patients of childbearing potential must have negative serum or urine pregnancy test at screening;
- Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives [any hormonal method in conjunction with a secondary method], intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile [at least 6 months prior to Study drug administration] sexual partner) for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle. Cessation of birth control after this point should be discussed with a responsible physician. Investigator will discuss with patient on the above points and the patient agreement will be documented in the source document. The investigator should ensure that the patient is using an effective method of avoiding pregnancy as per protocol. In case of Male patients: Either patient partners or patients themselves must use an effective method of avoiding pregnancy for at least 4 weeks prior to study drug administration, during study and up to 30 days or till next chemotherapy cycle.
Who cannot join
- Patients who have received non-investigational anti-tumor therapies (such as chemotherapy, radiotherapy, immunotherapy, biological therapy or traditional Chinese medicine treatment) within 2 weeks prior to study drug administration;
- Patients with hypersensitivity reaction caused by previous anti-microtubule drugs;
- Patients who have known brain metastasis; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable are eligible;
- Patients with a history of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. Atrial fibrillation is allowed if rate is controlled;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements;
- Patients with baseline QTc interval > 470 msec;
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- Patients with known history of human immunodeficiency virus (HIV) infection with an exception that if they have not had an opportunistic infection within the past 12 months, they are eligible;
- Patients who are HBV DNA positive;
- Patients with pre-existing > Grade 1 peripheral sensory neuropathy (NCI CTCAE 5.0) ;
- Patients who still experience ≥ Grade 2 acute toxicities caused by previous anti-tumor therapies (e.g. chemotherapy, radiotherapy, immunotherapy, biological therapy or TCM treatment) prior to enrollment (NCI-CTCAE 5.0, except alopecia);
- Patients who have undergone any major surgery or have major trauma within 4 weeks prior to administration of the investigational product or are expected to undergo major surgery during the first cycle of treatment;
- Patients who have received other investigational treatments within 4 weeks prior to administration of the investigational product.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Southern California
Los Angeles, California, 90007
Jacob Thomas, MD
About this study
Official title: Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors
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.
Read the detailed description
At least 4 dose cohorts are planned, and 16-28 cases are expected.
- Cohort 1 and 2: 2 cases are planned for each.
- Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design.
- Conditions
- Advanced Solid Tumor
- Being tested
- Utidelone Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone CapsuleDrug
At least 4 dose cohorts are planned, and 16-28 cases are expected.
- Cohort 1 and 2: 2 cases are planned for each. In cohort 1, the subjects will receive Utidelone Capsule at a dose of 25 mg/m2/d for 5 days, in a 21-day cycle. In cohort 2, the subjects will receive Utidelone Capsule at a dose of 50 mg/m2/d for 5 days, in a 21-day cycle.
- Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design. The subjects in these cohorts will receive Utidelone Capsule at 75 mg/m2/d for 5 days, 100 mg/m2/d for 5 days, 100 mg/m2/d for 7 days, and 120 mg/m2/d for 7 days in a 21-day cycle respectively.
| Study group | Role | What they receive |
|---|---|---|
| Utidelone Capsule at 25 mg/m2/d for 5 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
| Utidelone Capsule at 50 mg/m2/d for 5 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
| Utidelone Capsule at 75 mg/m2/d for 5 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
| Utidelone Capsule at 100 mg/m2/d for 5 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
| Utidelone Capsule at 100 mg/m2/d for 7 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
| Utidelone Capsule at 120 mg/m2/d for 7 days | Experimental | 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. Receives: Drug: Utidelone Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose, MTD
The maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced DLT attributable to the study drug(s), when 6 patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the study drug(s).
Measured: 12 months
Dose-Limiting Toxicity, DLT
DLT is observed during Cycle 1 in the dose escalation trial. Any toxicity meeting the criteria outlined in the protocol, at least possibly related to study drug (i.e. definitely, probably, or possibly attributed), will be considered a DLT.
Measured: 12 months
Secondary outcomes (6)
Maximum (or peak) serum concentration-Cmax
Cmax of Utidelone Capsule
Measured: 12 months
Time to peak drug concentration-Tmax
Tmax of Utidelone Capsule
Measured: 12 months
the area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
the AUC0-t of Utidelone Capsule
Measured: 12 months
the time required for plasma concentration of a drug to decrease by 50%-t1/2
the t1/2 of Utidelone Capsule
Measured: 12 months
Objective Response Rate-ORR
The percentage of patients who have a partial response or complete response to the treatment within a certain period of time.
Measured: 12 months
Recommended Phase II Dose (RP2D)
To recommend the dose and dose regimen for subsequent clinical trials.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start9 Jun 2023
- Primary completion15 Apr 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- At least 4 dose cohorts are planned, and 16-28 cases are expected. 1. Cohort 1: 2 subjects are planned to take 25 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 2. Cohort 2: 2 subjects are planned to take 50 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 3. Cohort 3: 3-6 subjects are planned to take 75 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 4. Cohort 4: 3-6 subjects are planned to take 100 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 5. Cohort 5: 3-6 subjects are planned to take 100 mg/m2/d by QD for 7 consecutive days in a 21-day cycle. 6. Cohort 6: 3-6 subjects are planned to take 120 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biostar Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Thomas, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681000
- Sponsor's protocol ID
- BG02-2201
- Status last verified
- Dec 2022
- First submitted
- 30 Dec 2022
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study on the Tolerability of Utidelone Capsule in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05681000
- Acronym / sponsor ID
- BG02-2201
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Biostar Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
At least 4 dose cohorts are planned, and 16-28 cases are expected.
- Cohort 1 and 2: 2 cases are planned for each.
- Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- At least 4 dose cohorts are planned, and 16-28 cases are expected. 1. Cohort 1: 2 subjects are planned to take 25 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 2. Cohort 2: 2 subjects are planned to take 50 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 3. Cohort 3: 3-6 subjects are planned to take 75 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 4. Cohort 4: 3-6 subjects are planned to take 100 mg/m2/d by QD for 5 consecutive days in a 21-day cycle. 5. Cohort 5: 3-6 subjects are planned to take 100 mg/m2/d by QD for 7 consecutive days in a 21-day cycle. 6. Cohort 6: 3-6 subjects are planned to take 120 mg/m2/d by QD for 7 consecutive days in a 21-day cycle.
| Arm | Type | Receives |
|---|---|---|
| Utidelone Capsule at 25 mg/m2/d for 5 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
| Utidelone Capsule at 50 mg/m2/d for 5 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
| Utidelone Capsule at 75 mg/m2/d for 5 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
| Utidelone Capsule at 100 mg/m2/d for 5 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
| Utidelone Capsule at 100 mg/m2/d for 7 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
| Utidelone Capsule at 120 mg/m2/d for 7 days | Experimental | Drug: Utidelone CapsuleCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to sign a written informed consent;
- Patients with histologic or pathologic documentation of incurable, locally advanced, or metastatic solid tumors for which standard therapies are not available, no longer effective, and not tolerated, and for those patients who have declined the standard therapies;
- Male or female subjects aged ≥18, with ECOG performance status scored 0-1;
- Expected survival time ≥ 12 weeks;
- Adequate organ and marrow function as defined below:
Key exclusion criteria (12 listed)
- Patients who have received non-investigational anti-tumor therapies (such as chemotherapy, radiotherapy, immunotherapy, biological therapy or traditional Chinese medicine treatment) within 2 weeks prior to study drug administration;
- Patients with hypersensitivity reaction caused by previous anti-microtubule drugs;
- Patients who have known brain metastasis; patients whose CNS metastases have been treated by surgery or radiotherapy, who are no longer on corticosteroids, and who are neurologically stable are eligible;
- Patients with a history of the following within 6 months prior to Cycle 1 Day 1: a myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled hypertension, clinically significant cardiac dysrhythmia or ECG abnormality, cerebrovascular accident, transient ischemic attack, or seizure disorder. Atrial fibrillation is allowed if rate is controlled;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Utidelone CapsuleAt least 4 dose cohorts are planned, and 16-28 cases are expected. 1. Cohort 1 and 2: 2 cases are planned for each. In cohort 1, the subjects will receive Utidelone Capsule at a dose of 25 mg/m2/d for 5 days, in a 21-day cycle. In cohort 2, the subjects will receive Utidelone Capsule at a dose of 50 mg/m2/d for 5 days, in a 21-day cycle. 2. Other dose-escalation cohorts: 3-6 cases are planned in each cohort, following the 3 + 3 design. The subjects in these cohorts will receive Utidelone Capsule at 75 mg/m2/d for 5 days, 100 mg/m2/d for 5 days, 100 mg/m2/d for 7 days, and 120 mg/m2/d for 7 days in a 21-day cycle respectively. | Drug | Utidelone Capsule at 100 mg/m2/d for 5 days, Utidelone Capsule at 100 mg/m2/d for 7 days, Utidelone Capsule at 120 mg/m2/d for 7 days, Utidelone Capsule at 25 mg/m2/d for 5 days, Utidelone Capsule at 50 mg/m2/d for 5 days, Utidelone Capsule at 75 mg/m2/d for 5 days |
Primary outcome
Maximum Tolerated Dose, MTD
Time frame: 12 months
The maximum tolerated dose (MTD) is defined as the highest dose tested in which none or only one patient experienced DLT attributable to the study drug(s), when 6 patients were treated at that dose and are evaluable for toxicity. The MTD is one dose level below the lowest dose tested in which 2 or more patients experienced DLT attributable to the study drug(s).
Dose-Limiting Toxicity, DLT
Time frame: 12 months
DLT is observed during Cycle 1 in the dose escalation trial. Any toxicity meeting the criteria outlined in the protocol, at least possibly related to study drug (i.e. definitely, probably, or possibly attributed), will be considered a DLT.
6 secondary outcomes
Maximum (or peak) serum concentration-Cmax
Time frame: 12 months
Time to peak drug concentration-Tmax
Time frame: 12 months
the area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
Time frame: 12 months
the time required for plasma concentration of a drug to decrease by 50%-t1/2
Time frame: 12 months
Objective Response Rate-ORR
Time frame: 12 months
Recommended Phase II Dose (RP2D)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Thomas, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Utidelone Capsule in people with Advanced Solid Tumor, run by Biostar Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RONGGUO QIU, PhD (01186-56315388, rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose, MTD (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.