SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A (SC0191 + Gemcitabine). SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. |
Drug: SC0191
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
Other Names:
Drug: Gemcitabine
Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
Other Names:
|
| Experimental: Arm B (SC0191 + Paclitaxel). SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle. Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle. |
Drug: SC0191
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
Other Names:
Drug: Paclitaxel
Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel [From the first dose of study treatment until 30 days after the last dose.]
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
- To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel [Through Cycle 1 (cycle is 28 days）]
Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
Secondary Outcome Measures
- To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel [Through Cycle 1 (cycle is 28 days）]
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-τ, Rac.
- To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel [Through completion]
Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
- To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel [Through completion]
Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria
- To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel [Through completion]
Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria
- To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel [Through completion]
Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
- To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel [Through completion]
Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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);
-
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);
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There is at least one measurable lesion that meets the definition of RECIST 1.1;
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Voluntarily participate in clinical trials and sign informed consent;
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Age ≥18 years;
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ECOG score of 0 to 1;
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Predicted life expectancy ≥3 months;
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Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
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Female patients who agree to use adequate contraceptive measures.
Exclusion Criteria:
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Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs <28 days prior to the first dose of study treatment.
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Patients who have not fully recovered from surgery according to the investigator's judgment.;
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Patients who have previously received WEE1 inhibitor treatment;
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Unresolved AEs or toxicities due to previous treatments;
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Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
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Known malignant CNS disease other than neurologically stable, treated brain metastases;
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Other medical conditions or systemic diseases not suitable to participate;
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The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;
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Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;
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Pregnant or lactating women.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Biocity Biopharmaceutics Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SC0191-102