SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

NCT06055348 | Unknown Phase 1

• 1 other identifier: SC0191-102
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Serous Ovarian Cancer; Advanced Ovarian Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (6)

• To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel

  Through Cycle 1 (cycle is 28 days）

• To obtain estimates of clinical activity by determining the objective response rate (ORR) of SC0191 in combination with gemcitabine or paclitaxel

  Through completion

• To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel

  Through completion

• To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel

  Through completion

• To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel

  Through completion

Study Arms (2)

Arm A (SC0191 + Gemcitabine).

EXPERIMENTAL

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.

Drug: SC0191; Drug: Gemcitabine

Arm B (SC0191 + Paclitaxel).

EXPERIMENTAL

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.

Drug: SC0191; Drug: Paclitaxel

Interventions

SC0191 DRUG

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

Also known as: Study drug

Arm A (SC0191 + Gemcitabine).; Arm B (SC0191 + Paclitaxel).

Gemcitabine DRUG

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

Also known as: Gemcitabine Injection

Arm A (SC0191 + Gemcitabine).

Paclitaxel DRUG

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

Also known as: Taxol

Arm B (SC0191 + Paclitaxel).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead

MeSH Terms

Interventions

Drug Evaluation; Gemcitabine; Paclitaxel

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xiaohua Wu

CONTACT

021-64175590; wu.xh@fudan.edu.cn

Jian Zhang

CONTACT

021-64175590; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 26, 2023
• Study Start: October 30, 2023
• Primary Completion: August 30, 2025
• Study Completion: November 30, 2025
• Last Updated: September 26, 2023

Record last verified: 2023-09