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SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

Primary Purpose

Serous Ovarian Cancer, Advanced Ovarian Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SC0191
Gemcitabine
Paclitaxel
Sponsored by
Biocity Biopharmaceutics Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Serous Ovarian Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Arm A (SC0191 + Gemcitabine).

    Arm B (SC0191 + Paclitaxel).

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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

    Secondary Outcome Measures

    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-τ, Rac.
    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
    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
    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
    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
    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

    Full Information

    First Posted
    August 15, 2023
    Last Updated
    September 20, 2023
    Sponsor
    Biocity Biopharmaceutics Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06055348
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 30, 2023 (Anticipated)
    Primary Completion Date
    August 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biocity Biopharmaceutics Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Serous Ovarian Cancer, Advanced Ovarian Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    112 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Arm A (SC0191 + Gemcitabine).
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Arm B (SC0191 + Paclitaxel).
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    SC0191
    Other Intervention Name(s)
    Study drug
    Intervention Description
    SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Gemcitabine
    Other Intervention Name(s)
    Gemcitabine Injection
    Intervention Description
    Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Other Intervention Name(s)
    Taxol
    Intervention Description
    Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
    Primary Outcome Measure Information:
    Title
    To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel
    Description
    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
    Time Frame
    From the first dose of study treatment until 30 days after the last dose.
    Title
    To identify the recommended Phase 2 dose (RP2D) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
    Time Frame
    Through Cycle 1 (cycle is 28 days)
    Secondary Outcome Measure Information:
    Title
    To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    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-τ, Rac.
    Time Frame
    Through Cycle 1 (cycle is 28 days)
    Title
    To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
    Time Frame
    Through completion
    Title
    To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria
    Time Frame
    Through completion
    Title
    To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria
    Time Frame
    Through completion
    Title
    To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
    Time Frame
    Through completion
    Title
    To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel
    Description
    Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
    Time Frame
    Through completion

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaohua Wu
    Phone
    021-64175590
    Ext
    200000
    Email
    wu.xh@fudan.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jian Zhang
    Phone
    021-64175590
    Ext
    200000
    Email
    syner2000@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

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