Status:
UNKNOWN
SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
Lead Sponsor:
Biocity Biopharmaceutics Co., Ltd.
Conditions:
Serous Ovarian Cancer
Advanced Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
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.
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 withad...
Eligibility Criteria
Inclusion
- 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);
- There is at least one measurable lesion that meets the definition of RECIST 1.1;
- Voluntarily participate in clinical trials and sign informed consent;
- Age ≥18 years;
- ECOG score of 0 to 1;
- Predicted life expectancy ≥3 months;
- Adequate bone marrow, liver biochemistry, renal function, and coagulation status.
- Female patients who agree to use adequate contraceptive measures.
Exclusion
- Received chemotherapy, radiotherapy, immunotherapy or biological therapy, steroid therapy or other investigational drugs \<28 days prior to the first dose of study treatment.
- Patients who have not fully recovered from surgery according to the investigator's judgment.;
- Patients who have previously received WEE1 inhibitor treatment;
- Unresolved AEs or toxicities due to previous treatments;
- Patients with contraindications or a history of severe allergies to gemcitabine or paclitaxel;
- Known malignant CNS disease other than neurologically stable, treated brain metastases;
- Other medical conditions or systemic diseases not suitable to participate;
- The need for long-term therapeutic doses of anticoagulant or antiplatelet drugs;
- Received CYP3A4 moderate or strong inhibitors or CYP3A4 moderate or strong inducers within 14 days;
- Pregnant or lactating women.
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT06055348
Start Date
October 30 2023
End Date
November 30 2025
Last Update
September 26 2023
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