SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

NCT ID: NCT06055348

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2025-11-30

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.

Conditions

Serous Ovarian Cancer; Advanced Ovarian Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SC0191

Intervention Type: DRUG

SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.

Gemcitabine

Intervention Type: DRUG

Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

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.

Group Type: EXPERIMENTAL

SC0191

Intervention Type: DRUG

SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.

Paclitaxel

Intervention Type: DRUG

Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

Interventions

SC0191

SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.

Intervention Type: DRUG

Gemcitabine

Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

Intervention Type: DRUG

Paclitaxel

Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

Intervention Type: DRUG

Other Intervention Names

Study drug; Gemcitabine Injection; Taxol

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Biocity Biopharmaceutics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Xiaohua Wu

Role: CONTACT

wu.xh@fudan.edu.cn

021-64175590 ext. 200000

Jian Zhang

Role: CONTACT

syner2000@163.com

021-64175590 ext. 200000

Other Identifiers

SC0191-102

Identifier Type: -

Identifier Source: org_study_id