Study on STC-1010 and Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

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What is this study about?

This clinical trial is focused on studying a type of cancer known as unresectable locally advanced or metastatic colorectal cancer. This means the cancer has spread to other parts of the body and cannot be removed through surgery. The trial is testing a new treatment called STC-1010, which is a form of immunotherapy. Immunotherapy is a treatment that helps the body’s immune system fight cancer. The study will also use other medications, including ENDOXAN (containing anhydrous cyclophosphamide), CALCIUM FOLINATE, FLUOROURACIL, and OXALIPLATIN, which are commonly used in chemotherapy to treat cancer.

The purpose of this study is to understand the safety and effectiveness of the STC-1010 treatment when used alongside standard care for patients with this type of colorectal cancer. The study will be conducted in two phases. In the first phase, the focus will be on determining the safety of the treatment and finding the right dose. In the second phase, the study will look at how well the treatment works in controlling the cancer. Participants will receive the treatment and be monitored over time to see how their cancer responds.

Throughout the study, participants will receive regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to provide valuable information on whether this new treatment can be a safe and effective option for people with advanced colorectal cancer. The trial is expected to continue for several years to gather comprehensive data on the treatment’s impact.

1 initial treatment phase

The trial begins with the administration of ENDOXAN (anhydrous cyclophosphamide) in the form of a coated tablet. This medication is taken orally.

The dosage and frequency of ENDOXAN will be determined by the healthcare provider based on individual patient needs and trial protocols.

2 combination therapy

Following the initial treatment, a combination of medications is administered intravenously. This includes CALCIUM FOLINATE, FLUOROURACIL, and OXALIPLATIN.

The specific dosages and schedule for these medications will be provided by the healthcare team, tailored to the patient’s condition and response to treatment.

3 immunotherapy administration

The trial includes the administration of STC-1010, an immunotherapy, given intradermally. This is part of the investigational treatment regimen.

The frequency and duration of STC-1010 administration will be guided by the trial protocol and monitored by the healthcare team.

4 supportive care

Throughout the trial, Leukine (sargramostim) may be administered intradermally to support the immune system.

The healthcare provider will determine the need for Leukine based on the patient’s response to treatment and overall health status.

5 monitoring and evaluation

Regular monitoring of health status, including blood tests and imaging, will be conducted to assess the effectiveness of the treatment and any side effects.

The healthcare team will evaluate the patient’s progress and make necessary adjustments to the treatment plan as needed.

6 end of treatment and follow-up

Upon completion of the treatment phase, follow-up visits will be scheduled to monitor long-term health outcomes and any delayed side effects.

The duration of follow-up will be determined by the trial protocol and the healthcare provider’s assessment.

Who Can Join the Study?

Must be a male or female aged between 18 and 75 years.
Must have a life expectancy of more than 3 months, as determined by the doctor.
Must have certain blood test results within specific ranges:
- Lymphocyte count greater than 1,000 per cubic millimeter.
- Absolute neutrophil count at least 1,500 per microliter.
- Hemoglobin level greater than 9 grams per deciliter.
- Platelet count at least 100,000 per microliter.
- Liver enzymes (AST and ALT) no more than 3 times the normal limit (or 5 times if there are liver metastases).
- Bilirubin no more than 1.5 times the normal limit (or 3 times if you have Gilbert’s disease).
- Serum creatinine no more than 1.5 times the normal limit.
- Estimated glomerular filtration rate (GFR) greater than 50 milliliters per minute per 1.73 square meters.
Must have certain blood clotting test results within specific ranges:
- ACT less than 1.5 times normal or Prothrombin rate greater than 70%.
Must agree to use birth control measures:
- Women of childbearing potential must have a negative pregnancy test, use effective birth control, not donate eggs, and not breastfeed during the study and for 6 months after.
- Men must use a condom with spermicide, not donate sperm, and not plan to father a child during the study and for 6 months after.
Must be affiliated with social security insurance, if required by local regulations.
Must have specific types of tumors confirmed by tests:
- For certain study groups, must have MSS/pMMR tumors confirmed by tests.
- For other study groups, must have MSI-H/dMMR tumors confirmed by tests.
Must be eligible for specific treatments, such as mFOLFOX6 + bevacizumab.
Must have a confirmed diagnosis of advanced or metastatic colorectal cancer that cannot be removed by surgery.
Must have a certain type of immune system marker (MHC/HLA Class I positive).
Must have had certain chemotherapy treatments if more than 6 months have passed since the end of treatment and the first relapse.
Must have a measurable disease according to specific criteria (RECIST 1.1).
Must agree to have a biopsy at the start and during the study, if it is safe and possible.
Must have an ECOG performance status of 1 or less, which measures daily living abilities. Participants over 70 must have a status of 0.
Must have signed a consent form agreeing to participate in the study.

Who Cannot Join the Study?

Patients who have had another type of cancer in the past, unless it was a type that is not likely to come back.
Patients who have serious heart problems, like a recent heart attack or heart failure.
Patients who have uncontrolled high blood pressure, which means their blood pressure is not well managed with medication.
Patients who have an active infection that needs treatment with antibiotics.
Patients who are pregnant or breastfeeding.
Patients who have a known allergy to the study medication or any of its ingredients.
Patients who have participated in another clinical trial within the last 30 days.
Patients who have a condition that the study doctors believe would make it unsafe for them to participate.
Patients who have a history of drug or alcohol abuse that could interfere with the study.
Patients who have a mental health condition that could make it difficult for them to follow the study instructions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France

Other Sites

Site Name	City	Country
Institut Jules Bordet	Anderlecht	Belgium
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Georges-François Leclerc	Dijon	France
Ietltrsp Raflylfx Dq Clqink Dm Mqtliwvnirx	Montpellier	France
Ceswtm Lsqc Bagsmu	Lyon	France

Trial status

Country	Status	Recruitment Start
Belgium	Not yet recruiting	01.04.2025
France	Recruiting	01.04.2025

Trial locations

Investigated drugs:

STC-1010 is an immunotherapy being tested in patients with colorectal cancer that cannot be surgically removed and has spread to other parts of the body. This treatment aims to help the body’s immune system recognize and attack cancer cells more effectively.

IS regimen refers to a supportive treatment used alongside STC-1010. It is designed to enhance the immune system’s response to the cancer, working together with the main immunotherapy to improve its effectiveness.

SOC therapy stands for Standard of Care therapy, which includes the usual treatments given to patients with colorectal cancer. This can involve chemotherapy, radiation, or other established methods that are typically used to manage this type of cancer. In this trial, SOC therapy is combined with STC-1010 and the IS regimen to evaluate the overall treatment effectiveness.

Investigated diseases:

Colorectal Cancer – Colorectal cancer is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, noncancerous clumps of cells called polyps that form on the inside of the colon or rectum. Over time, some of these polyps can become cancerous. The disease can be locally advanced, meaning it has spread to nearby tissues, or metastatic, meaning it has spread to other parts of the body. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.

Trial ID:

2024-512011-45-00

Protocol code:

BreAK CRC 001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on STC-1010 and Drug Combination for Patients with Advanced or Metastatic Colorectal Cancer

What is this study about?

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