Study of SCO-101 with FOLFIRI for Patients with Metastatic Colorectal Cancer Resistant to FOLFIRI

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What is this study about?

This clinical trial is focused on studying a treatment for Metastatic Colorectal Cancer, which is a type of cancer that has spread from the colon or rectum to other parts of the body. The study is investigating a new treatment combination that includes a medication with the code name SCO-101 and a chemotherapy regimen known as FOLFIRI. FOLFIRI is a combination of drugs that includes Fluorouracil, Irinotecan Hydrochloride, and Disodium Folinate. The purpose of the study is to determine the safety and effectiveness of this new treatment combination in patients whose cancer has become resistant to FOLFIRI.

Participants in the study will receive the treatment over a period of time, with regular monitoring to assess how well the treatment is working and to check for any side effects. The study will help researchers understand the best dose of SCO-101 when used with FOLFIRI and how well this combination can control the cancer. The treatment will be given in cycles, and the response to the treatment will be evaluated using imaging techniques like MRI or CT scans to see if the cancer is shrinking or stable.

The study aims to provide valuable information on whether this new combination can be a safe and effective option for patients with advanced colorectal cancer that has not responded to standard treatments. By participating in this study, researchers hope to find a new way to manage this challenging condition and improve outcomes for patients in the future.

1 initial treatment phase

The trial begins with the administration of the combination treatment, which includes SCO-101 and FOLFIRI. FOLFIRI is a chemotherapy regimen that includes fluorouracil, irinotecan hydrochloride, and disodium folinate.

The treatment is administered in cycles. Each cycle consists of intravenous infusions of the medications. Fluorouracil is given as an injection with a concentration of 25 mg/ml. Irinotecan hydrochloride is provided as a concentrate for infusion at 20 mg/ml.

The oral medication SCO-101 is taken in tablet form. The dosage and frequency are determined based on the maximum tolerated dose identified during the trial.

2 monitoring and assessment

Throughout the trial, regular monitoring is conducted to assess the safety and tolerability of the treatment. This includes evaluating any adverse effects experienced during the treatment period.

The effectiveness of the treatment is assessed using imaging techniques such as CT scans or MRIs. These assessments help determine the response of the cancer to the treatment.

3 dose adjustment

Based on the initial response and any side effects, adjustments to the dosage of SCO-101 may be made to ensure the maximum tolerated dose is not exceeded.

The goal is to find a balance between minimizing side effects and maximizing the treatment’s effectiveness.

4 evaluation of treatment response

After 20 weeks from the start of the treatment, an evaluation is conducted to assess the objective response rate. This involves determining the extent of tumor reduction or stabilization.

The criteria used for this evaluation are based on standardized guidelines for measuring tumor response.

5 end of treatment and follow-up

The treatment phase concludes after the specified duration, and a follow-up period begins. This involves continued monitoring for any delayed side effects and assessing the long-term effectiveness of the treatment.

The follow-up period also includes additional imaging studies to track the progression of the disease.

Who Can Join the Study?

Must be able to understand and agree to sign a written consent form before starting any trial activities.
Must have recovered from any previous surgery or treatment side effects to a mild level.
At least 2 weeks should have passed since any previous surgery.
Must have certain blood and liver test results within specific limits, such as:
- Absolute neutrophils count (ANC) should be at least 1.5 x 10⁹/L.
- Hemoglobin should be at least 6.0 mmol/L.
- Platelets should be at least 100 x 10⁹/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be no more than 2.5 times the upper limit of normal (ULN).
- Total serum bilirubin should be no more than 1.0 ULN.
- Alkaline phosphatase should be no more than 2.5 times ULN.
- Normal kidney function as defined by local standards.
- Adequate blood clotting function with an International Normalized Ratio (INR) of 1.5 or less.
Must have a life expectancy of at least 3 months.
Sexually active males and females who can have children must use effective birth control during the study and for at least 6 months after the last dose of the study drug.
Must have signed the informed consent form.
Eligible only if no other standard treatment options are available, meaning:
- They have not responded to all available standard treatments, and/or
- They cannot tolerate all remaining standard treatments, and/or
- They choose not to undergo any other standard treatments, and/or
- Their doctor believes no further standard treatment can be offered for their cancer.
Must be 18 years or older.
Must have a confirmed diagnosis of colorectal adenocarcinoma, a type of colon cancer.
Must have non-resectable metastatic colorectal cancer (mCRC), meaning the cancer cannot be surgically removed. Specific genetic mutations may be present or absent depending on the study stage.
Must have previously been treated with certain chemotherapy drugs, including irinotecan and 5-FU, and shown disease progression.
Must have had a maximum reduction of 33% in the previous dose of FOLFIRI, a chemotherapy regimen.
Must have been treated with an oxaliplatin-containing regimen and not be suitable for further treatment with oxaliplatin.
For certain stages of the study, must have disease that can be evaluated or measured by CT scan or MRI.
Must have a performance status of ECOG 1 or less, which means they are fully active or have some symptoms but do not require bed rest.

Who Cannot Join the Study?

Patients who have a different type of cancer than Metastatic Colorectal Cancer cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to safely receive the study treatment due to other health conditions cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are unable to follow the study procedures or attend study visits cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have certain allergies or reactions to the study drugs cannot participate.
Patients who have a history of certain medical conditions that could interfere with the study cannot participate.
Patients who are taking medications that could interfere with the study treatment cannot participate.
Patients who have a history of substance abuse that could interfere with the study cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Hm Sanchinarro	Madrid	Spain

Other Sites

Site Name	City	Country
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Hsfotyzq Do Lq Ssdqw Cawb I Scuc Pcc	Barcelona	Spain
Hkddcany Vgth dwkjmgov	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	03.05.2022

Trial locations

Investigated drugs:

SCO-101 is an experimental medication being studied for its potential to enhance the effectiveness of cancer treatments. In this trial, it is being tested to see if it can help treat patients with advanced colorectal cancer who have not responded to standard treatments. Researchers are looking at how safe it is to use and what side effects it might cause when combined with other cancer drugs.

FOLFIRI is a combination of cancer-fighting drugs used to treat colorectal cancer. It includes a mix of medications that work together to stop cancer cells from growing and spreading. In this trial, FOLFIRI is being used alongside SCO-101 to see if the combination can be more effective in treating patients with advanced colorectal cancer.

Metastatic Colorectal Cancer – This is a type of cancer that originates in the colon or rectum and has spread to other parts of the body, such as the liver or lungs. The disease typically begins as a growth, called a polyp, on the inner lining of the colon or rectum, which can become cancerous over time. As the cancer progresses, it can invade nearby tissues and organs, and eventually spread to distant sites through the bloodstream or lymphatic system. The progression of metastatic colorectal cancer can vary, with some patients experiencing rapid spread, while others may have a slower progression. Symptoms may include changes in bowel habits, blood in the stool, abdominal pain, and unexplained weight loss. The disease is often diagnosed at an advanced stage due to the lack of early symptoms.

Trial ID:

2024-518877-33-00

Protocol code:

SCO101-001

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of SCO-101 with FOLFIRI for Patients with Metastatic Colorectal Cancer Resistant to FOLFIRI

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?