Advanced Solid TumorPhase 1/2NCT05700084
Phase I-II Clinical Trial of Utidelone Capsule in Patients With Advanced Solid Tumors
A Phase 1/2 study testing Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B) and Drug A Utidelone Capsule (Part 2: Group B-A) in people with Advanced Solid Tumor, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 10 sites in China.
Trial summary
This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine. The primary objectives are 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B) and Drug A Utidelone Capsule (Part 2: Group B-A)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 10 sitesChina
- Study dates
- 9 Jun 2023to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All inclusion criteria must be met for enrollment:
- Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a participant and signs the informed consent form.
- Part 1 and Part 2: Patients with definitive histopathological diagnosis of advanced solid tumors. Part 3: Patients were diagnosed with advanced metastatic breast cancer by pathology and/or cytology.
- Part 1 and Part 2: Male or female participants aged ≥18 and ≤65, Part 3: Male or female participants aged ≥18 and ≤70, with ECOG performance status scored 0-1.
- Expected survival time ≥ 12 weeks;
- At least one measurable lesion present according to RECIST 1.1 criteria.
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- Baseline routine blood tests within 1 week prior to enrollment is normal (not received blood transfusions or hematopoietic-stimulating factors within 14 days), with CTCAE grade ≤1 (based on normal values at each site's laboratory): a) Neutrophil count (ANC) ≥ 1.5 × 109/L; b) platelet count (PLT ) ≥ 100 × 109/L; c) Hemoglobin ≥9.0 g/dL.
- Liver and kidney function test results are normal within 1 week prior to enrollment, with CTCAE grade ≤1 (based on normal values at each site's laboratory): a) Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN); b) Serum Glutamic Pyruvic Transaminase/Alanine Aminotransferease (SGPT /ALT) ≤ 2.5× ULN (Part 3 allowed ≤5×ULN in patients with liver metastases); c) Serum Glutamic-oxaloacetic Transaminase/Aspartate Aminotransferase (SGOT /AST) ≤ 2.5× ULN (Part 3 allowed ≤5×ULN in patients with liver metastases); d) Creatinine clearance (Ccr) ≥60 ml/min.
- Patients with no functional disorders of major organs.
- Fertile males and females of childbearing potential must agree to use effective contraception (so do their partners, using hormonal or barrier contraception, or abstinence) during the study and within at least 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing potential prior to enrollment must be negative.
- Part 3: breast cancer patients who had received ≤4 previous chemotherapy regimens (adjuvant chemotherapy/neoadjuvant chemotherapy was considered as one chemotherapy regimen);
- Part 3: history of prior treatment with at least one anthracycline or one taxane as neoadjuvant/adjuvant or advance therapy or both.
Who cannot join
- Meet any exclusion criteria will be excluded from the study:
- Patients who have received non-investigational anti-tumor therapies (such as chemotherapy, radiotherapy, immunotherapy, biological therapy or traditional Chinese medicine treatment) within 4 weeks prior to study drug administration.
- Nitrosoureas or mitomycin C: within 6 weeks prior to study drug administration;
- Oral fluoropyrimidines and small molecule targeted agents: within 2 weeks or 5 half lives of the drug prior to study drug administration (whichever is longer);
- Traditional Chinese medicine with anti tumor indications and endocrine therapy for breast cancer: within 2 weeks prior to study drug administration.
- Participants with severe hypersensitivity to castor oil (this criteria is applicable to Part 2 of the study), and Participants who had hypersensitivity reaction caused by previous anti-microtubule drugs.
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- Patients with uncontrollable brain metastases (brain metastatic lesion confirmed by examination within 2 months after radiotherapy or other localized treatment); patients with uncontrollable bone metastases (patients who have had fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, patients with other critical conditions)
- Patients with serious comorbidities, such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infections, active peptic ulcers, etc.
- Patients with mental illnesses which are hard to control, patients who lack legal capacity or have limited legal capacity.
- Patients with gastrointestinal diseases such as esophageal obstruction, pyloric obstruction, intestinal obstruction, or who are post-operative of gastrointestinal resection, or who have difficulty in swallowing due to other factors, interfering with oral administration and absorption of the drug.
- Patients with active hepatitis B infections.
- Patients with peripheral neuropathy grade>1 within 4 weeks prior to enrollment (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 treatment.
- Patients who have participated in another clinical trial or have received other investigational treatments within 4 weeks prior to administration of the investigational product.
- Patients who, in the opinion of the investigator, are not suitable to participate in this study.
- Part 3: other malignant tumors within 5 years before enrollment, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, thyroid papillary carcinoma;
- Part 3: previous or current capecitabine therapy (except if capecitabine was used in neoadjuvant/adjuvant therapy and progression occurred > 12 months after completion of treatment, inclusion was allowed);
- Part 3: patients with previous fluorouracil medication history with severe allergy or known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Part 3: previous or current use of utidelone (including utidelone injection and utidelone capsule); 17) Part 3: pregnant or lactating patients; 18) Part 3: uncontrolled pleural effusion, pericardial effusion or ascites (drainage once a month or more); 19) Part 3: a history of immunodeficiency, including positive HIV antibody test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
China10 sites
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
The Fifth Medical Center of Chinese PLA General Hospital
Beijing
Sichuan Cancer Hospital
Chengdu
Sun Yat-sen University Cancer Center
Guangzhou
Cancer Hospital of Shandong First Medical University
Jinan
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
LiaoNing Cancer Hospital&Institute
Shenyang
The Fourth Hospital of Hebei Medical University
Shijiazhuang
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of XI'an JiaoTong University
Xi'an
About this study
Official title: Phase I-II Clinical Trial on Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors
This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine. The primary objectives are 1. To evaluate the safety and tolerability of utidelone capsules in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT). 2. To evaluate the objective response rate in patients with advanced metastatic breast cancer treated with the combination of utidelone capsule and capecitabine. The secondary objectives are: 1. to evaluate the absolute bioavailability of utidelone capsules relative to utidelone injection; 2. to evaluate the pharmacokinetic profile of utidelone capsules in patients with advanced solid tumors; 3. to preliminarily evaluate the efficacy and safety of utidelone capsules in patients with advanced solid tumors; and 4. to recommend doses and dosing regimens for subsequent clinical trials. 5. To evaluate the Progression-Free Survival (PFS), safety and pharmacokinetics of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.
Read the detailed description
Part 1 is a dose-escalation trial, and it's an open design; Part 2 is a pharmacokinetic comparison and food effect study, and it's an open, controlled study;Part 3: Extended trial of combination of utidelone capsule and capecitabine.
- Conditions
- Advanced Solid Tumor
- Being tested
- Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B), Drug A Utidelone Capsule (Part 2: Group B-A), Drug B Utidelone Injection (Part 2: Group A-B), Drug B Utidelone Injection (Part 2: Group B-A)
- Keywords
- Tolerability, Bioavailability, Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone Capsule (Part 1)Drug
At least 3 dose cohorts are planned, and 14-26 cases are expected. Cohort 1: 2 cases are planned, and the subjects will receive Utidelone Capsule at a dose of 50 mg/m2/d for 5 days.
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 A Utidelone Capsule (Part 2: Group A-B)Drug
Utidelone Capsule at Part 2 in Group A-B will be administered at 60 mg/m2/d.
At Cycle 0, on day 1, all patients will receive the drug in fasted status with a glass (approximately 240 ml) of warm water (2 h of fasting before administration; 2 h of fasting after administration).
At Cycle 2, subjects will receive the drug after meals on days 1-5 (high-fat meal, drug taken 30 min after the meal; 2 h fasting after administration). Subjects will receive the drug on day 1-5 with 21 days as a cycle.
For the subsequent treatment period, there is no special requirements for food. Subjects will receive the drug on day 1-5 with 21 days as a cycle.
Drug A Utidelone Capsule (Part 2: Group B-A)Drug
Utidelone Capsule at Part 2 in Group B-A will be administered at 60 mg/m2/d.
At Cycle 1, on day 1-5, all patients will receive the drug in fasted status with a glass (approximately 240 ml) of warm water (2 h of fasting before administration; 2 h of fasting after administration), with 21 days as a cycle.
At Cycle 2, subjects will receive the drug after meals on days 1-5 (high-fat meal, drug taken 30 min after the meal; 2 h fasting after administration), with 21 days as a cycle.
For the subsequent treatment period, there is no special requirements for food. Subjects will receive the drug on day 1-5 with 21 days as a cycle.
Drug B Utidelone Injection (Part 2: Group A-B)Drug
Utidelone Injection at Part 2 in Group A-B will be administered at 30 mg/m2/d in 250 mL normal saline, intravenous drip over1.5 h.
For Cycle 1, subjects will be administered Utidelone Injection on day 1-5 with 21 days as a cycle.
Drug B Utidelone Injection (Part 2: Group B-A)Drug
Utidelone Injection at Part 2 in Group B-A will be administered at 30 mg/m2/d in 250 mL normal saline, intravenous drip over1.5 h.
For Cycle 0, all patients will be administered Utidelone Injection on day 1, with 21 days as a cycle.
CapecitabineDrug
1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals. It is administered continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle.
Utidelone Capsule (Part 3)Drug
Utidelone capsule: 60 mg/m2/d, administered once a day on an empty stomach, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Utidelone Capsule (Part 1) | Experimental | Utidelone Capsule, available as 10 mg/capsule and 15 mg /capsule. Doses between 50 mg/m2/d and 120 mg/m2/d administered orally will be explored. Patients will be dosed for 5/7 consecutive days in a 21 day cycle. Receives: Drug: Utidelone Capsule (Part 1) |
| Utidelone Capsule/Utidelone Injection (Group A-B, Part 2) | Experimental | At cycle 0, patients will take Utidelone Capsule in fasted status at 60 mg/m2/d. At cycle 1, patients will be administered Utidelone Injection by iv drip at 30 mg/m2/d. At Cycle 2, patients will take Utidelone Capsule (after meals) at 60 mg/m2/d. Receives: Drug: Drug A Utidelone Capsule (Part 2: Group A-B); Drug: Drug B Utidelone Injection (Part 2: Group A-B) |
| Utidelone Injection/Utidelone Capsule (Group B-A, Part 2) | Experimental | At cycle 0, patients will be administered Utidelone Injection by iv drip at 30 mg/m2/d. At cycle 1, patients will take Utidelone Capsule in fasted status at 60 mg/m2/d. At cycle 2, patients will take Utidelone Capsule (after meals) at 60 mg/m2/d. Receives: Drug: Drug A Utidelone Capsule (Part 2: Group B-A); Drug: Drug B Utidelone Injection (Part 2: Group B-A) |
| Utidelone Capsule combination with Capecitabine | Experimental | Dosage:
Utidelone capsule: 60 mg/m2/d, administered once a day on an empty stomach, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days.
Capecitabine: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals. It is administered continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle. Receives: Drug: Capecitabine; Drug: Utidelone Capsule (Part 3) |
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: 8 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: 8 months
Objective Response Rate, ORR
To evaluate the objective response rate (ORR) of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer
Measured: 6 weeks
Secondary outcomes (8)
Bioavailability of Utidelone Capsule
Endpoint indicator: F
Measured: 8 months
Maximum (or peak) serum concentration-Cmax
Cmax of Utidelone Capsule
Measured: 8 months
Time to peak drug concentration-Tmax
Tmax of Utidelone Capsule
Measured: 8 months
the area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
the AUC0-t of Utidelone Capsule
Measured: 8 months
the time required for plasma concentration of a drug to decrease by 50%-t1/2
the t1/2 of Utidelone Capsule
Measured: 8 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
Treatment-related Adverse Event-TRAE
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 12 months
Progression-Free Survival, PFS
To evaluate the Progression-Free Survival (PFS) of eutidrone capsules combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start9 Jun 2023
- Primary completion8 Oct 2025
- Study completion31 Dec 2026 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Study design: Part 1 is a dose-escalation trial, and it's an open design; Part 2 is for pharmacokinetic comparison and food effect study, and it's an open, controlled design. Part 3 is expansion test of utidelone capsule combined with capecitabine. In the Part 1 dose-escalation trial, there is no control; in the Part 2 pharmacokinetic comparison and food effect study, utidelone injection is chosen as the control drug in Cycle 0 and 1; in Cycle 2 day1, high-fat postprandial dosing is served as the control.Part 3: expansion test of utidelone capsule combined with capecitabine dosage administered.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, MD, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700084
- Sponsor's protocol ID
- BG02-2101
- Status last verified
- Aug 2026
- First submitted
- 30 Dec 2022
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Clinical Trial on Tolerability and Bioavailability of Utidelone Capsule in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05700084
- Acronym / sponsor ID
- BG02-2101
- Conditions
- Advanced Solid Tumor
- Keywords
- Tolerability, Bioavailability, Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 8 Oct 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 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.
This study has three parts. Part 1 is a dose-escalation trial, Part 2 is a pharmacokinetic comparison and food effect study, and Part 3 is extended trial of combination of utidelone capsule and capecitabine. The primary objectives are 1. To evaluate the safety and tolerability of utidelone capsules in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT). 2. To evaluate the objective response rate in patients with advanced metastatic breast cancer treated with the combination of utidelone capsule and capecitabine. The secondary objectives are: 1. to evaluate the absolute bioavailability of utidelone capsules relative to utidelone injection; 2. to evaluate the pharmacokinetic profile of utidelone capsules in patients with advanced solid tumors; 3. to preliminarily evaluate the efficacy and safety of utidelone capsules in patients with advanced solid tumors; and 4. to recommend doses and dosing regimens for subsequent clinical trials. 5. To evaluate the Progression-Free Survival (PFS), safety and pharmacokinetics of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer.
Detailed description
Part 1 is a dose-escalation trial, and it's an open design; Part 2 is a pharmacokinetic comparison and food effect study, and it's an open, controlled study;Part 3: Extended trial of combination of utidelone capsule and capecitabine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Study design: Part 1 is a dose-escalation trial, and it's an open design; Part 2 is for pharmacokinetic comparison and food effect study, and it's an open, controlled design. Part 3 is expansion test of utidelone capsule combined with capecitabine. In the Part 1 dose-escalation trial, there is no control; in the Part 2 pharmacokinetic comparison and food effect study, utidelone injection is chosen as the control drug in Cycle 0 and 1; in Cycle 2 day1, high-fat postprandial dosing is served as the control.Part 3: expansion test of utidelone capsule combined with capecitabine dosage administered.
| Arm | Type | Receives |
|---|---|---|
| Utidelone Capsule (Part 1) | Experimental | Drug: Utidelone Capsule (Part 1)Utidelone Capsule, available as 10 mg/capsule and 15 mg /capsule. Doses between 50 mg/m2/d and 120 mg/m2/d administered orally will be explored. Patients will be dosed for 5/7 consecutive days in a 21 day cycle. |
| Utidelone Capsule/Utidelone Injection (Group A-B, Part 2) | Experimental | Drug: Drug A Utidelone Capsule (Part 2: Group A-B), Drug: Drug B Utidelone Injection (Part 2: Group A-B)At cycle 0, patients will take Utidelone Capsule in fasted status at 60 mg/m2/d. At cycle 1, patients will be administered Utidelone Injection by iv drip at 30 mg/m2/d. At Cycle 2, patients will take Utidelone Capsule (after meals) at 60 mg/m2/d. |
| Utidelone Injection/Utidelone Capsule (Group B-A, Part 2) | Experimental | Drug: Drug A Utidelone Capsule (Part 2: Group B-A), Drug: Drug B Utidelone Injection (Part 2: Group B-A)At cycle 0, patients will be administered Utidelone Injection by iv drip at 30 mg/m2/d. At cycle 1, patients will take Utidelone Capsule in fasted status at 60 mg/m2/d. At cycle 2, patients will take Utidelone Capsule (after meals) at 60 mg/m2/d. |
| Utidelone Capsule combination with Capecitabine | Experimental | Drug: Capecitabine, Drug: Utidelone Capsule (Part 3)Dosage: Utidelone capsule: 60 mg/m2/d, administered once a day on an empty stomach, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. Capecitabine: 1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals. It is administered continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a participant and signs the informed consent form.
- Part 1 and Part 2: Patients with definitive histopathological diagnosis of advanced solid tumors. Part 3: Patients were diagnosed with advanced metastatic breast cancer by pathology and/or cytology.
- Part 1 and Part 2: Male or female participants aged ≥18 and ≤65, Part 3: Male or female participants aged ≥18 and ≤70, with ECOG performance status scored 0-1.
- Expected survival time ≥ 12 weeks;
- At least one measurable lesion present according to RECIST 1.1 criteria.
Key exclusion criteria (20 listed)
- Patients who have received non-investigational anti-tumor therapies (such as chemotherapy, radiotherapy, immunotherapy, biological therapy or traditional Chinese medicine treatment) within 4 weeks prior to study drug administration.
- Participants with severe hypersensitivity to castor oil (this criteria is applicable to Part 2 of the study), and Participants who had hypersensitivity reaction caused by previous anti-microtubule drugs.
- Patients with uncontrollable brain metastases (brain metastatic lesion confirmed by examination within 2 months after radiotherapy or other localized treatment); patients with uncontrollable bone metastases (patients who have had fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, patients with other critical conditions)
- Patients with serious comorbidities, such as severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, severe infections, active peptic ulcers, etc.
- Patients with mental illnesses which are hard to control, patients who lack legal capacity or have limited legal capacity.
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 Capsule (Part 1)At least 3 dose cohorts are planned, and 14-26 cases are expected. Cohort 1: 2 cases are planned, and the subjects will receive Utidelone Capsule at a dose of 50 mg/m2/d for 5 days. 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 (Part 1) |
| Drug A Utidelone Capsule (Part 2: Group A-B)Utidelone Capsule at Part 2 in Group A-B will be administered at 60 mg/m2/d. At Cycle 0, on day 1, all patients will receive the drug in fasted status with a glass (approximately 240 ml) of warm water (2 h of fasting before administration; 2 h of fasting after administration). At Cycle 2, subjects will receive the drug after meals on days 1-5 (high-fat meal, drug taken 30 min after the meal; 2 h fasting after administration). Subjects will receive the drug on day 1-5 with 21 days as a cycle. For the subsequent treatment period, there is no special requirements for food. Subjects will receive the drug on day 1-5 with 21 days as a cycle. | Drug | Utidelone Capsule/Utidelone Injection (Group A-B, Part 2) |
| Drug A Utidelone Capsule (Part 2: Group B-A)Utidelone Capsule at Part 2 in Group B-A will be administered at 60 mg/m2/d. At Cycle 1, on day 1-5, all patients will receive the drug in fasted status with a glass (approximately 240 ml) of warm water (2 h of fasting before administration; 2 h of fasting after administration), with 21 days as a cycle. At Cycle 2, subjects will receive the drug after meals on days 1-5 (high-fat meal, drug taken 30 min after the meal; 2 h fasting after administration), with 21 days as a cycle. For the subsequent treatment period, there is no special requirements for food. Subjects will receive the drug on day 1-5 with 21 days as a cycle. | Drug | Utidelone Injection/Utidelone Capsule (Group B-A, Part 2) |
| Drug B Utidelone Injection (Part 2: Group A-B)Utidelone Injection at Part 2 in Group A-B will be administered at 30 mg/m2/d in 250 mL normal saline, intravenous drip over1.5 h. For Cycle 1, subjects will be administered Utidelone Injection on day 1-5 with 21 days as a cycle. | Drug | Utidelone Capsule/Utidelone Injection (Group A-B, Part 2) |
| Drug B Utidelone Injection (Part 2: Group B-A)Utidelone Injection at Part 2 in Group B-A will be administered at 30 mg/m2/d in 250 mL normal saline, intravenous drip over1.5 h. For Cycle 0, all patients will be administered Utidelone Injection on day 1, with 21 days as a cycle. | Drug | Utidelone Injection/Utidelone Capsule (Group B-A, Part 2) |
| Capecitabine1000mg/m2, twice a day (daily dose 2000mg/m2), once in the morning and once in the evening, taken orally within 30 minutes after meals. It is administered continuously for 14 days from day 1 to day 14, with a 21 day treatment cycle. | Drug | Utidelone Capsule combination with Capecitabine |
| Utidelone Capsule (Part 3)Utidelone capsule: 60 mg/m2/d, administered once a day on an empty stomach, continuously for 5 days from day 1 to day 5, with a treatment cycle of 21 days. | Drug | Utidelone Capsule combination with Capecitabine |
Primary outcome
Maximum Tolerated Dose, MTD
Time frame: 8 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: 8 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.
Objective Response Rate, ORR
Time frame: 6 weeks
To evaluate the objective response rate (ORR) of utidelone capsule combined with capecitabine in the treatment of patients with advanced metastatic breast cancer
8 secondary outcomes
Bioavailability of Utidelone Capsule
Time frame: 8 months
Maximum (or peak) serum concentration-Cmax
Time frame: 8 months
Time to peak drug concentration-Tmax
Time frame: 8 months
the area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
Time frame: 8 months
the time required for plasma concentration of a drug to decrease by 50%-t1/2
Time frame: 8 months
Objective Response Rate-ORR
Time frame: 12 months
Treatment-related Adverse Event-TRAE
Time frame: 12 months
Progression-Free Survival, PFS
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Binghe Xu, MD, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Utidelone Capsule (Part 1), Drug A Utidelone Capsule (Part 2: Group A-B) and Drug A Utidelone Capsule (Part 2: Group B-A) in people with Advanced Solid Tumor, run by Beijing Biostar Pharmaceuticals Co., Ltd. at 10 sites in China.
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 12 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose, MTD (time frame: 8 months). The study lists 3 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 27 Aug 2026.