Ovarian CancerPhase 2NCT07044349
Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
A Phase 2 study testing Utidelone capsule 75mg/m2/d QD, Utidelone capsule 40mg/m2/d BID and Utidelone capsule 50mg/m2/d BID in people with Ovarian Cancer and Fallopian Tube Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd..
Trial summary
This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
- What is being tested?
- Utidelone capsule 75mg/m2/d QD, Utidelone capsule 40mg/m2/d BID and Utidelone capsule 50mg/m2/d BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Mar 2027
- Phase
- Phase 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who voluntarily sign the informed consent form, are willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other study procedures.
- Female participants aged ≥ 18 years when signing the informed consent form.
- Pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Participants with at least one measurable lesion as defined per RECIST v1.1.
- Participants must meet the criteria for platinum-resistant recurrence, which is defined as disease progression during platinum-based therapy or disease progression or recurrence within 6 months after the last platinum-based therapy. Note: Participants must have radiographically confirmed disease progression during or after the most recent line of systemic therapy. Biochemical progression is not considered disease progression in this study.
- Participants must meet the requirements of failure or intolerance to the existing standard of treatment or no standard of treatment. Prior use of at least 1 but ≤ 3 lines of systemic antitumor treatment (neoadjuvant and adjuvant treatment are not considered prior systemic treatment, unless disease progression occurred during treatment or within 6 months after the last dose of treatment). Maintenance therapy (e.g., bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors, hormonal therapy) is considered part of the prior line of treatment. Treatment changes due to toxicity without progression will be considered part of the prior line of treatment (i.e., not counted separately).
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Hematology test within 7 days prior to enrollment (based on the laboratory normal range at each site), and no use of recombinant human granulocyte colony-stimulating factor (rhG-CSF) or blood products /erythropoietin (EPO) within 14 days prior to the laboratory test during the screening period.
- Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL.
- Blood chemistry test within 7 days prior to enrollment (based on the laboratory normal range at each site); Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); ALT ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastases); AST ≤ 3 × ULN (≤ 5 × ULN for participants with liver metastasis); Creatinine clearance (Ccr) ≥ 60 mL/min (calculated by Cockcroft-Gault formula).
- Life expectancy ≥ 12 weeks.
- Female participants of childbearing potential must agree to use highly effective contraceptive methods and not to donate eggs during the study and for 8 weeks after the last dose of study treatment. Female patients of childbearing potential must have a negative blood or urine pregnancy test result at screening and be willing to undergo additional pregnancy tests as needed throughout the study. See Appendix 1 for details.
Who cannot join
- The best overall response during the first-line platinum-based treatment is disease progression, or disease recurrence or progression within 3 months after the end of the platinum-based treatment.
- History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.
- Anti-tumor therapy, including chemotherapy, radiotherapy, target therapy, immunotherapy, etc. within 4 weeks prior to the first dose of the investigational drug, except for the following items;
- Received nitrosourea or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
- Oral fluorouracil, small molecule targeted drugs, or endocrine therapy within 2 weeks or within 5 half-lives of the drug prior to the first dose of the investigational drug, whichever is shorter;
- Use of traditional Chinese medicine with anti-tumor indications or endocrine therapy within 2 weeks prior to the first dose of the investigational drug.
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- Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy, or as defined by the investigator) or have experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or those who require elective surgery during the study.
- Participants with adverse reactions due to previous antitumor therapy that have not recovered to Grade ≤1 (based on CTCAE 5.0), except toxicities without safety risks as judged by the investigator, such as alopecia.
- Participants with gastrointestinal perforation, gastrointestinal fistula, or intra-abdominal abscess, or patients with gastrointestinal hemorrhage, gastrointestinal obstruction (including paralytic ileus), or imaging/clinical symptoms suggestive of bowel obstruction within 3 months prior to the first use of the investigational product;
- Participants who are unable to take oral medications, or with other factors that interfere with the oral administration and absorption of the drug, or those who require total parenteral nutrition.
- Participants who need concomitant use of strong CYP3A4 inhibitors or inducers, or medications that prolong the QT interval, within 14 days prior to the first use of the investigational product or during the study.
- Participants with symptomatic or uncontrolled central nervous system (CNS) metastases or meningeal metastases, i.e., patients with brain metastasis disease progression confirmed by examination within 2 months after radiotherapy or other local treatments, or patients who are judged by the investigator to be unsuitable for enrollment.
- Uncontrolled bone metastases, i.e., patients who have experienced fracture or have the risk of fracture in recent days, patients who need surgery or localized radiotherapy in recent days, or those with other critical conditions as determined by the investigator.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently).
- History of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- Patients with acute myocardial infarction, severe/uncontrolled angina, or coronary artery bypass surgery within 6 months prior to the first dose of the investigational product; congestive heart failure with a New York Heart Association (NYHA) classification ≥ 2; left ventricular ejection fraction (LVEF) < 50%; Fridericia corrected QT interval > 470 ms (average of three measurements); or a history of myocarditis (including patients with a past history of myocarditis that recovered after treatment) or other Grade ≥ 3 cardiovascular events.
- Stroke and/or transient ischemic attack within 6 months prior to the first dose of the investigational product; Uncontrolled hypertension despite standard treatment; Other heart diseases at high risk, as judged by the investigator.
- Participants with uncontrolled diabetes mellitus.
- Participants with active hepatitis B and/or hepatitis C, i.e., HBsAg positive and HBV DNA positive; anti-HCV positive and HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum specific antibody.
- Participants who had active infection prior to screening and initial use of the investigational drug and required systemic anti-infective therapy.
- Pregnant or breastfeeding women, or women who plan to become pregnant during the study.
- Participants with mental disorder or poor compliance.
- Participants with prior use of utidelone.
- Participants with known hypersensitivity to the investigational product or any of the excipients.
- Participants who simultaneously participate in another interventional clinical trial or use other investigational therapies.
- Participants who, in the opinion of the investigator, are not suitable to participate in this study due to history of severe systemic diseases or other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiaohua Wu contact
About this study
This is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.
Read the detailed description
This study will be two cohorts:
Cohort 1: 30 participants are planned to be enrolled. The administration regimen is Utidelone Capsules at 75 mg/m2/d once a day. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
Cohort 2: 6 to 12 participants are planned to be enrolled during the safety run-in part, and 30 participants are planned to be enrolled during the expansion part. The administration regimen is the twice daily (BID) administration of Utidelone capsules. The dosage of expansion part will be determined according to the safety run-in part. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
The safety run-in part use a dose-escalation design. The initial dose was 40 mg/m2 of utidelone capsules BID. The escalation group was set at 50 mg/m2 BID or the de-escalation group at 35 mg/m2 BID. 6 participants will be enrolled in each dose group to evaluate dose-limiting toxicity (DLT).
After the completion of DLT observation during the safety run-in part, one administration regimen will be determined for the dose expansion period.
- Being tested
- Utidelone capsule 75mg/m2/d QD, Utidelone capsule 40mg/m2/d BID, Utidelone capsule 50mg/m2/d BID, Utidelone capsule 35mg/m2/d BID
- Keywords
- UTD2, Utidelone Capsule
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Utidelone capsule 75mg/m2/d QDDrug
75mg/m2/d, QD, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
Utidelone capsule 40mg/m2/d BIDDrug
40mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
Utidelone capsule 50mg/m2/d BIDDrug
50mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
Utidelone capsule 35mg/m2/d BIDDrug
35mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Utidelone capsule 75mg/m2/d QD |
| Cohort 2 initial group | Experimental | Not described Receives: Drug: Utidelone capsule 40mg/m2/d BID |
| Cohort 2 escalation group | Experimental | Not described Receives: Drug: Utidelone capsule 50mg/m2/d BID |
| Cohort 2 de-escalation group | Experimental | Not described Receives: Drug: Utidelone capsule 35mg/m2/d BID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen
Measured: Until 21 days after the first dose of treatment
The incidence of adverse events (AE)/serious adverse events (SAE)
Measured: Until 28 days after the last dose of treatment
Secondary outcomes (7)
Objective response rate (ORR)
based on RECIST v1.1
Measured: 18 months
Disease control rate (DCR)
Measured: 18 months
Progression-free survival (PFS)
Measured: 18 months
Maximum (or peak) serum concentration-Cmax
Measured: 18 months
Time to peak drug concentration-Tmax
Measured: 18 months
The area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
Measured: 18 months
The time required for plasma concentration of a drug to decrease by 50%-t1/2
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044349
- Sponsor's protocol ID
- BG02-2502
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 30 Jun 2025
- 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 30 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT07044349
- Acronym / sponsor ID
- BG02-2502
- Keywords
- UTD2, Utidelone Capsule
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Beijing Biostar Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 30 Jun 2025 (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 is an open, multicenter, phase II clinical study enrolling patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer to evaluate the safety and efficacy of Utidelone Capsules. Approximately 72 patients will be included in this study.
Detailed description
This study will be two cohorts:
Cohort 1: 30 participants are planned to be enrolled. The administration regimen is Utidelone Capsules at 75 mg/m2/d once a day. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
Cohort 2: 6 to 12 participants are planned to be enrolled during the safety run-in part, and 30 participants are planned to be enrolled during the expansion part. The administration regimen is the twice daily (BID) administration of Utidelone capsules. The dosage of expansion part will be determined according to the safety run-in part. Fasting (fasting for 2 hours before administration and 1 hour after administration)is required from the 1st to the 5th day of each 21-day cycle.
The safety run-in part use a dose-escalation design. The initial dose was 40 mg/m2 of utidelone capsules BID. The escalation group was set at 50 mg/m2 BID or the de-escalation group at 35 mg/m2 BID. 6 participants will be enrolled in each dose group to evaluate dose-limiting toxicity (DLT).
After the completion of DLT observation during the safety run-in part, one administration regimen will be determined for the dose expansion period.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Utidelone capsule 75mg/m2/d QD |
| Cohort 2 initial group | Experimental | Drug: Utidelone capsule 40mg/m2/d BID |
| Cohort 2 escalation group | Experimental | Drug: Utidelone capsule 50mg/m2/d BID |
| Cohort 2 de-escalation group | Experimental | Drug: Utidelone capsule 35mg/m2/d BID |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants who voluntarily sign the informed consent form, are willing and able to comply with the scheduled visits, study treatment plan, laboratory tests, and other study procedures.
- Female participants aged ≥ 18 years when signing the informed consent form.
- Pathologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Participants with at least one measurable lesion as defined per RECIST v1.1.
- Participants must meet the criteria for platinum-resistant recurrence, which is defined as disease progression during platinum-based therapy or disease progression or recurrence within 6 months after the last platinum-based therapy. Note: Participants must have radiographically confirmed disease progression during or after the most recent line of systemic therapy. Biochemical progression is not considered disease progression in this study.
Key exclusion criteria (26 listed)
- The best overall response during the first-line platinum-based treatment is disease progression, or disease recurrence or progression within 3 months after the end of the platinum-based treatment.
- History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.
- Anti-tumor therapy, including chemotherapy, radiotherapy, target therapy, immunotherapy, etc. within 4 weeks prior to the first dose of the investigational drug, except for the following items;
- Participants who have undergone major surgery (craniotomy, thoracotomy, or laparotomy, or as defined by the investigator) or have experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or those who require elective surgery during the study.
- Participants with adverse reactions due to previous antitumor therapy that have not recovered to Grade ≤1 (based on CTCAE 5.0), except toxicities without safety risks as judged by the investigator, such as alopecia.
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 75mg/m2/d QD75mg/m2/d, QD, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. | Drug | Cohort 1 |
| Utidelone capsule 40mg/m2/d BID40mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. | Drug | Cohort 2 initial group |
| Utidelone capsule 50mg/m2/d BID50mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. | Drug | Cohort 2 escalation group |
| Utidelone capsule 35mg/m2/d BID35mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle. | Drug | Cohort 2 de-escalation group |
Primary outcome
Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen
Time frame: Until 21 days after the first dose of treatment
The incidence of adverse events (AE)/serious adverse events (SAE)
Time frame: Until 28 days after the last dose of treatment
7 secondary outcomes
Objective response rate (ORR)
Time frame: 18 months
Disease control rate (DCR)
Time frame: 18 months
Progression-free survival (PFS)
Time frame: 18 months
Maximum (or peak) serum concentration-Cmax
Time frame: 18 months
Time to peak drug concentration-Tmax
Time frame: 18 months
The area under the concentration-time curve from dosing (time 0) to time t-AUC0-t
Time frame: 18 months
The time required for plasma concentration of a drug to decrease by 50%-t1/2
Time frame: 18 months
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 30 Jun 2025.
- 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.
Xiaohua Wu contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Utidelone capsule 75mg/m2/d QD, Utidelone capsule 40mg/m2/d BID and Utidelone capsule 50mg/m2/d BID in people with Ovarian Cancer and Fallopian Tube Cancer, run by Beijing Biostar Pharmaceuticals Co., Ltd..
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 26 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: opening soon, as of the sponsor's last update on 30 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Contact Rongguo Qiu (010-56315388, Rqiu2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen (time frame: Until 21 days after the first dose of treatment). 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 30 Jun 2025.