A Study to Evaluate the Preliminary Safety and Efficacy of SC0191 as Single Agent or in Combination With Bevacizumab or 5-FU/LV in Advanced Colorectal Cancer

Tianshu Liu1 site in 1 country36 target enrollmentMay 2024

ConditionsMetastatic Colorectal Cancer

InterventionsSC0191 SC0191 + Bevacizumab SC0191 + 5-FU/LV

DrugsSC0191 SC0191 + Bevacizumab SC0191 + 5-FU/LV

Overview

Phase: Phase 2
Intervention: SC0191
Conditions: Metastatic Colorectal Cancer
Sponsor: Tianshu Liu
Enrollment: 36
Locations: 1
Primary Endpoint: Objective Response Rate
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this clinical trial is to evaluate the preliminary safety and efficacy of SC0191 as single agent or in combination with bevacizumab or 5-FU/LV in advanced colorectal cancer.

Registry

clinicaltrials.gov

Start Date

May 2024

End Date

December 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tianshu Liu

Responsible Party

Sponsor Investigator

Principal Investigator

Tianshu Liu

Director of Oncology Department

Shanghai Zhongshan Hospital

Eligibility Criteria

Inclusion Criteria

•Subjects voluntarily participate in the clinical study and sign an informed consent form;
•Male or female subjects aged ≥18 years;
•Subjects diagnosed with stage IV colorectal cancer confirmed by histology or cytology and not suitable for curative surgical treatment;
•Subjects who have previously received fluoropyrimidine-based chemotherapy, oxaliplatin, and irinotecan with or without anti-EGFR or anti-VEGF targeted therapy, and experienced disease progression or intolerance to the most recent treatment regimen; the number of prior lines of systemic antitumor therapy for advanced colorectal cancer does not exceed 2 lines;
•ECOG performance status of 0 to 1;
•Expected survival of ≥3 months;
•At least one measurable lesion according to RECIST 1.1 criteria, defined as a lesion with a longest diameter ≥10 mm on CT scan or MRI (excluding lymph nodes) or a short diameter ≥15 mm for lymph nodes. Lesions located in previously irradiated or otherwise locally treated areas are generally not considered measurable unless there is documented disease progression;
•Adequate organ function and bone marrow hematopoietic function;
•Fertile subjects (both male and female) must agree to use a reliable method of contraception (hormonal or barrier method, or abstinence) with their partners for at least 6 months from the time of signing the informed consent form until the last dose of the study drug; female subjects of childbearing potential must have a negative pregnancy test within 14 days before the first use of the investigational drug.

Exclusion Criteria

•Subjects known to be MSI-H who have not received immunotherapy;
•Subjects with spinal cord compression, symptomatic/unstable brain metastases, or leptomeningeal metastases. Exclusion: Subjects with stable symptoms of brain metastases after prior treatment (completion of definitive radiotherapy and/or surgery, cessation of corticosteroid therapy, and stable symptoms for at least 14 days);
•Subjects with radiological evidence of tumor invasion or encasement of major vessels (Cohort A);
•Subjects with uncontrollable pleural effusion, ascites, or pericardial effusion at screening;
•Subjects with a history of other malignant tumors within 5 years prior to study drug initiation, except for early-stage tumors cured by curative treatment, such as basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, superficial bladder cancer, localized prostate cancer, etc.;
•Subjects with significant cardiovascular diseases, including NYHA class II-IV heart failure, congestive heart failure, second-degree or higher atrioventricular block, myocardial infarction within the past 6 months, unstable arrhythmias or angina, significant QT interval prolongation (baseline-corrected QTc interval \>470 milliseconds on ECG), stroke within the past 6 months, or PTCA (percutaneous transluminal coronary angioplasty) or CABG (coronary artery bypass grafting) within the past 6 months;
•Subjects with poorly controlled hypertension;
•Subjects with viral infectious diseases at screening meeting the following criteria:
•HIV seropositivity;
•Hepatitis B: HBsAg positivity with HBV-DNA quantification above the upper limit of normal;