SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

• Status: Not yet recruiting
• Trial end date: 2025-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biocity Biopharmaceutics Co., Ltd.
• Treatments: Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced ovarian cancer that has failed or intolerant or not applicable to standard treatment (applicable to the dose escalation phase of stage Ib);

2. Histologically or cytologically confirmed advanced high-grade serous ovarian cancer, platinum-resistant or platinum-refractory recurrent ovarian cancer (applicable to the dose expansion phase of stage II);

3. There is at least one measurable lesion that meets the definition of RECIST 1.1;

4. Voluntarily participate in clinical trials and sign informed consent;

5. Age ≥18 years;

6. ECOG score of 0 to 1;

7. Predicted life expectancy ≥3 months;

8. Adequate bone marrow, liver biochemistry, renal function, and coagulation status.

9. Female patients who agree to use adequate contraceptive measures.

Exclusion Criteria:

1. Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs <28 days prior to the first dose of study treatment.

2. Patients who have not fully recovered from surgery according to the investigator's judgment.;

3. Patients who have previously received WEE1 inhibitor treatment;

4. Unresolved AEs or toxicities due to previous treatments;

5. Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;

6. Known malignant CNS disease other than neurologically stable, treated brain metastases;

7. Other medical conditions or systemic diseases not suitable to participate;

8. The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;

9. Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;

10. Pregnant or lactating women.