Advanced Ovarian Cancer Clinical Trial
Official title:
A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer.
A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.
Status | Not yet recruiting |
Enrollment | 112 |
Est. completion date | November 30, 2025 |
Est. primary completion date | August 30, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Biocity Biopharmaceutics Co., Ltd. |
Type | Measure | Description | Time frame | Safety issue |
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Primary | To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel | ncidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0 | From the first dose of study treatment until 30 days after the last dose. | |
Primary | To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel | Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1 | Through Cycle 1 (cycle is 28 days) | |
Secondary | To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel | Plasma pharmacokinetics (PK) of SC0191 in combination with chemotherapy: Single Dose SC0191 Cmax, Tmax, t1/2,AUC0-24h, AUC0-last, CL/F, Vd/F, and steady state SC0191 Ctrough, Cmax,ss, Cavg,ss, Tmax,ss, AUC0-t, Rac. | Through Cycle 1 (cycle is 28 days) | |
Secondary | To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel | Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1 | Through completion | |
Secondary | To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel | Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria | Through completion | |
Secondary | To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel | Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria | Through completion | |
Secondary | To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel | Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1 | Through completion | |
Secondary | To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel | Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1 | Through completion |
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