SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

Biocity Biopharmaceutics

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Serous Ovarian Cancer; Advanced Ovarian Cancer

Treatments: Drug: Paclitaxel; Drug: SC0191; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06055348

SC0191-102

Details and patient eligibility

About

A phase Ib/II clinical study on the safety, pharmacokinetic characteristics, and preliminary efficacy of SC0191 combination chemotherapy in patients with advanced ovarian cancer.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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112 participants in 2 patient groups

Arm A (SC0191 + Gemcitabine).

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: SC0191

Arm B (SC0191 + Paclitaxel).

Experimental group

Description:

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.

Treatment:

Drug: SC0191

Drug: Paclitaxel