SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

Launched by BIOCITY BIOPHARMACEUTICS CO., LTD. · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called SC0191 combined with chemotherapy for women with advanced ovarian cancer. The goal is to find out if this combination is safe, how it works in the body, and if it is effective in treating patients whose cancer has not responded to standard treatments. The trial is in the early phases, meaning they are still testing how well this new approach works.

To be eligible for this trial, participants must be women aged 18 and older who have been diagnosed with advanced ovarian cancer that hasn’t responded to regular treatments or for whom those treatments are not suitable. Participants should have at least one measurable tumor and a good overall health status. Those interested will need to sign a consent form to join the study. If you decide to participate, you'll receive careful monitoring and support throughout the trial, but there are specific health conditions and recent treatments that may prevent someone from joining.

Gender

FEMALE

Eligibility 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.