Metastatic Colorectal CancerPhase 2NCT06363552
A Study of SC-0191 in Subjects With Metastatic Colorectal Cancer
A Phase 2 study testing SC0191, SC0191 + Bevacizumab and SC0191 + 5-FU/LV in people with Metastatic Colorectal Cancer, run by Tianshu Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- SC0191, SC0191 + Bevacizumab and SC0191 + 5-FU/LV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- May 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Hepatitis C: HCV antibody positivity with HCV-RNA quantification above the upper limit of normal;
- Subjects with active infections requiring systemic antimicrobial therapy as judged by the investigator, deemed unsuitable for participation in this study;
- Subjects who have undergone allogeneic tissue/organ transplantation;
- Subjects with malabsorption syndrome or other gastrointestinal abnormalities that may significantly affect oral drug absorption (such as ulcerative lesions, uncontrollable nausea, vomiting, diarrhea, malabsorption syndrome, and small bowel resection, etc.);
- Subjects with hereditary bleeding or coagulation disorders, or a history of severe non-traumatic bleeding, or a history of ineffective platelet transfusion (within the past 1 year before initial study drug administration), or any disease that significantly increases the risk of bleeding;
- Subjects with a history of any of the following during treatment with Bevacizumab-based regimens (or biosimilars): venous or arterial thromboembolic events, gastrointestinal perforation, grade 4 hypertension, grade 3 proteinuria, or grade 3 or higher bleeding events (Cohort A).
- Subjects who have undergone major surgery, open biopsy, or experienced severe traumatic injury within 28 days before first use of the investigational drug, or are expected to undergo major surgery during the study. Subjects who have undergone minor surgery within 7 days before first use of the investigational drug, such as fine needle aspiration or core biopsy. Subjects with a history of esophageal varices or bleeding peptic ulcer within 3 months before first use of the investigational drug (Cohort A).
- Known history of dihydropyrimidine dehydrogenase (DPD) deficiency. History of discontinuing fluoropyrimidine treatment due to ≥3 grade diarrhea (Cohort B).
- Subjects with a history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring corticosteroid treatment, or any clinical evidence suggesting active interstitial lung disease;
- Subjects diagnosed with autoimmune diseases during screening or receiving long-term systemic corticosteroid therapy (dose exceeding 10 mg/day of prednisone or equivalent) or any other form of immunosuppressive therapy due to autoimmune diseases;
- Subjects whose toxicity from prior anticancer therapy has not resolved to ≤ grade 1 (CTCAE 5.0) (excluding alopecia, decreased hearing, and stable endocrine disorders treated with alternative therapies);
- Subjects previously treated with WEE1 inhibitors;
- Subjects with a history of hypersensitivity reactions to SC0191, Bevacizumab (Cohort A), fluoropyrimidines (Cohort B), calcium folinate (Cohort B) active ingredients, or their inactive excipients or similar drugs;
- Subjects who received radiation therapy to more than 25% of the bone marrow area within 28 days before first use of the investigational drug;
- Subjects vaccinated with live vaccines within 28 days before first use of the investigational drug.
- Subjects who received chemotherapy, biologic therapy, endocrine therapy, or other antitumor therapy within 28 days before first use of the investigational drug; or received small molecule targeted therapy within 28 days or 5 half-lives (whichever is shorter) before first use of the investigational drug; or received traditional Chinese medicine for antitumor therapy within 7 days before first use of the investigational drug;
- Subjects who received systemic corticosteroids (prednisone equivalent >10 mg/day) or other immunosuppressive therapy within 14 days before first use of the investigational drug, except for local, ocular, intra-articular, intranasal, and inhalational corticosteroid therapy; or received corticosteroids for prophylactic treatment (e.g., prevention of contrast agent allergy) ;
- Subjects who received moderate or potent inhibitors of CYP3A4 (such as amprenavir, atazanavir, boceprevir, clarithromycin, conivaptan, darunavir, diltiazem, erythromycin, foscarnet, indinavir, itraconazole, ketoconazole, lopinavir, mibefradil, miconazole, nefazodone, nelfinavir, posaconazole, ritonavir, telithromycin, verapamil, voriconazole, etc.) or moderate or potent inducers of CYP3A4 (such as carbamazepine, felbamate, nevirapine, phenobarbital, phenytoin, primidone, rifampin, efavirenz, modafinil, etc.) within 14 days before first use of the investigational drug;
- Subjects who require regular use of proton pump inhibitors (PPIs) during the study or received PPI therapy within 14 days before first use of the investigational drug (such as omeprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole, etc.);
- Subjects who require long-term therapeutic doses of anticoagulants or antiplatelet drugs (prophylactic use of low-dose anticoagulants is allowed, provided that the anticoagulation parameters specified in the inclusion criteria are met); low-dose anticoagulants may be used to maintain venous catheter patency;
- Subjects with psychiatric disorders or poor compliance;
- Pregnant or lactating female subjects;
- Subjects whom the investigator considers to have other serious systemic medical history, or for other reasons are not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: 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
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- SC0191, SC0191 + Bevacizumab, SC0191 + 5-FU/LV
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC0191Drug
The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.
SC0191 + BevacizumabDrug
- The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.
- Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle.
SC0191 + 5-FU/LVDrug
- The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle.
- Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days.
| Study group | Role | What they receive |
|---|---|---|
| SC0191 | Experimental | Not described Receives: Drug: SC0191 |
| SC0191 + Bevacizumab | Experimental | Not described Receives: Drug: SC0191 + Bevacizumab |
| SC0191 + 5-FU/LV | Experimental | Not described Receives: Drug: SC0191 + 5-FU/LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Measured: 12 months
Incidence and Severity of Dose Limiting Toxicities (DLTs)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianshu Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tianshu Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363552
- Sponsor's protocol ID
- WETARI
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06363552
- Acronym / sponsor ID
- WETARI
- Conditions
- Metastatic Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tianshu LiuUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SC0191 | Experimental | Drug: SC0191 |
| SC0191 + Bevacizumab | Experimental | Drug: SC0191 + Bevacizumab |
| SC0191 + 5-FU/LV | Experimental | Drug: SC0191 + 5-FU/LV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (33 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC0191The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. | Drug | SC0191 |
| SC0191 + Bevacizumab1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Bevacizumab injection is administered intravenously at a dose of 5mg/kg on day 1 and day 15 of each treatment cycle. | Drug | SC0191 + Bevacizumab |
| SC0191 + 5-FU/LV1. The SC0191 tablet is taken orally at a dose of 300mg once daily. Each treatment cycle consists of 28 days. Medication is administered on days 1 to 3, days 8 to 10, days 15 to 17, and days 22 to 24 of each cycle. 2. Calcium folinate 400mg/m2 intravenous infusion (over 2 hours or more), on the first day, followed by 5-fluorouracil 400mg/m2 intravenous bolus injection, then continuous intravenous infusion of 1200mg/m2/day for 2 days. | Drug | SC0191 + 5-FU/LV |
Primary outcome
Objective Response Rate
Time frame: 12 months
Incidence and Severity of Dose Limiting Toxicities (DLTs)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SC0191, SC0191 + Bevacizumab and SC0191 + 5-FU/LV in people with Metastatic Colorectal Cancer, run by Tianshu Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianshu Liu, MD, PhD (+86 136 8197 3996, tianshu.liu@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.