SC0191 Plus Chemotherapy in Advanced Ovarian Canceradvanced Ovarian Cancer

September 20, 2023 updated by: Biocity Biopharmaceutics Co., Ltd.

A Phase Ib/II Clinical Study on the Safety, Pharmacokinetic Characteristics, and Preliminary Efficacy of SC0191 Combination Chemotherapy in Patients With Advanced Ovarian Cancer.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: SC0191
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
Other Names:
  • Study drug
Drug: Gemcitabine
Gemcitabine 1000 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
Other Names:
  • Gemcitabine Injection
Experimental: 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.
Drug: SC0191
SC0191 PO will be taken on days 1-3, 8-10, and 15-17 of each 28 day cycle.
Other Names:
  • Study drug
Drug: Paclitaxel
Paclitaxel 80 mg/m² will be administered IV on days 1, 8, and 15 of each 28 day cycle.
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the safety and tolerability of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: From the first dose of study treatment until 30 days after the last dose.
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
Time Frame: Through Cycle 1 (cycle is 28 days）
Incidence and severity of dose-limiting toxicities (DLTs) in DLT-evaluable subjects during Cycle 1
Through Cycle 1 (cycle is 28 days）

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate the plasma pharmacokinetics (PK) of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: Through Cycle 1 (cycle is 28 days）
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.
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
Time Frame: Through completion
Objective response rate (ORR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Through completion
To obtain estimates of clinical activity by determining the time to CA125 progression of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: Through completion
Time to CA125 progression according to the Gynecologic Cancer Intergroup (GCIG) criteria
Through completion
To obtain estimates of clinical activity by determining the progression-free survival (PFS) of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: Through completion
Progression-free survival (PFS) as defined by RECIST version 1.1 and clinical criteria
Through completion
To obtain estimates of clinical activity by determining the duration of response (DOR) of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: Through completion
Duration of response (DOR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Through completion
To obtain estimates of clinical activity by determining the disease control rate (DCR) of SC0191 in combination with gemcitabine or paclitaxel
Time Frame: Through completion
Disease control rate (DCR) as defined by Response Evaluation Criteria in Solid Tumors RECIST version 1.1
Through completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocity Biopharmaceutics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2023

Primary Completion (Estimated)

August 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 26, 2023

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SC0191-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Advanced Ovarian Cancer

Clinical Trials on SC0191

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe