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

1. 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.

2. History of other malignancies within 5 years prior to enrollment, excluding cured skin basal cell carcinoma, cervical carcinoma in situ, or papillary thyroid carcinoma.

3. 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;

1. Received nitrosourea or mitomycin C within 6 weeks prior to the first dose of the investigational drug;

2. 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;

3. Use of traditional Chinese medicine with anti-tumor indications or endocrine therapy within 2 weeks prior to the first dose of the investigational drug.

4. 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.

5. 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.

6. 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;

7. 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.

8. 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.

9. 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.

10. 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.

11. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once per month or more frequently).

12. 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.

13. Participants with uncontrolled diabetes mellitus.

14. 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.

15. Participants who had active infection prior to screening and initial use of the investigational drug and required systemic anti-infective therapy.

16. Pregnant or breastfeeding women, or women who plan to become pregnant during the study.

17. Participants with mental disorder or poor compliance.

18. Participants with prior use of utidelone.

19. Participants with known hypersensitivity to the investigational product or any of the excipients.

20. Participants who simultaneously participate in another interventional clinical trial or use other investigational therapies.

21. 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.

What this study is about