Clinical trial NCT06055348: SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer
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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Serous Ovarian Cancer
Advanced Ovarian Cancer
Lead sponsor: Biocity Biopharmaceutics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-26
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 withadvanced ovarian cancer.

Part 2 Dose Expansion of SC0191 plus Chemotherapy.

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.

Primary outcomes:
measure: To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: From the first dose of study treatment until 30 days after the last dose.
measure: To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through Cycle 1 (cycle is 28 days）
Secondary outcomes:
measure: To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through Cycle 1 (cycle is 28 days）
measure: To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through completion
measure: To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through completion
measure: To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through completion
measure: To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through completion
measure: To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel
timeFrame: Through completion
Other outcomes:
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