Phase II Clinical Study of Utidelone Capsule (UTD2) in Patients With Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT07044349 | Not Yet Recruiting Phase 2

• 1 other identifier: BG02-2502
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

UTD2; Utidelone Capsule

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT) and the maximum tolerated dose of the BID administration regimen

  Until 21 days after the first dose of treatment

• The incidence of adverse events (AE)/serious adverse events (SAE)

  Until 28 days after the last dose of treatment

Secondary Outcomes (7)

• Objective response rate (ORR)

  18 months

• Disease control rate (DCR)

  18 months

• Progression-free survival (PFS)

  18 months

• Maximum (or peak) serum concentration-Cmax

  18 months

• Time to peak drug concentration-Tmax

  18 months

Study Arms (4)

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

Interventions

Utidelone capsule 75mg/m2/d QD DRUG

75mg/m2/d, QD, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Cohort 1

Utidelone capsule 40mg/m2/d BID DRUG

40mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Cohort 2 initial group

Utidelone capsule 50mg/m2/d BID DRUG

50mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Cohort 2 escalation group

Utidelone capsule 35mg/m2/d BID DRUG

35mg/m2/d, BID, D1-D5 for 5 consecutive days, every 21 days as a treatment cycle.

Cohort 2 de-escalation group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Beijing Biostar Pharmaceuticals Co., Ltd.: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Central Study Contacts

Rongguo Qiu

CONTACT

010-56315388; Rqiu2001@yahoo.com

Xiaohua Wu

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: June 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: June 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share