SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

Advanced Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06055348
• Other study ID #: SC0191-102
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: September 2023
• Source: Biocity Biopharmaceutics Co., Ltd.
• Contact: Xiaohua Wu
• Phone: 021-64175590
• Email: wu.xh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: November 30, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Serous Ovarian Cancer

Intervention

Drug:
• SC0191
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
• Gemcitabine
Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
• Paclitaxel
Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biocity Biopharmaceutics Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel	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	From the first dose of study treatment until 30 days after the last dose.
Primary	To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel	Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1	Through Cycle 1 (cycle is 28 days)
Secondary	To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel	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-t, Rac.	Through Cycle 1 (cycle is 28 days)
Secondary	To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel	Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1	Through completion
Secondary	To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel	Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria	Through completion
Secondary	To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel	Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria	Through completion
Secondary	To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel	Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1	Through completion
Secondary	To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel	Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1	Through completion