The phase 1b/2,multicenter, open-label study, contains 2 parts.
Part 1 Dose Escalation of SC0191 combination chemotherapy:
Part 1 will estimate the RP2D in dose escalation cohorts in patients withadvanced ovarian cancer.
Part 2 Dose Expansion of SC0191 plus Chemotherapy.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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;
