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Study on CTL-002 and Nivolumab for Patients with Advanced-Stage, Relapsed/Refractory Solid Tumors

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for people with advanced-stage, relapsed/refractory solid tumors. These are types of cancer that have returned or are not responding to existing treatments. The study will test a new medication called CTL-002, which will be given alone or in combination with another type of medication known as an anti-PD-1 checkpoint inhibitor. These inhibitors, such as LIBTAYO and OPDIVO, help the immune system recognize and attack cancer cells.

The purpose of the study is to explore how well CTL-002 works when used with an anti-PD-1 checkpoint inhibitor in treating these difficult-to-treat cancers. Participants will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in two parts. In the first part, the focus will be on understanding the safety and tolerability of CTL-002. In the second part, the study will look at how effective the treatment is in shrinking tumors and improving the condition of the participants.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. The study aims to provide new insights into the treatment of advanced cancers that have not responded to other therapies. By participating, individuals will contribute to research that could lead to new treatment options for these challenging conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status.
A biopsy of accessible tumor lesions is required unless deemed unsafe by the treating physician. This biopsy helps in understanding the tumor characteristics.
Step 2
Treatment phase 1
The first phase of treatment involves the administration of CTL-002 as a monotherapy or in combination with an anti-PD-1 checkpoint inhibitor.
The medication is given intravenously, meaning it is delivered directly into the bloodstream through a vein.
Step 3
Treatment phase 2
In the second phase, the treatment continues with CTL-002 in combination with an anti-PD-1 checkpoint inhibitor, such as LIBTAYO or OPDIVO.
The dosage and frequency of administration are determined based on the specific protocol of the study.
Step 4
Monitoring and evaluation
Throughout the trial, regular monitoring is conducted to assess the response to treatment. This includes imaging tests like CT or MRI to measure tumor size.
Blood tests are performed to evaluate the levels of certain proteins and to monitor for any side effects.
Step 5
End of treatment
At the end of the treatment period, a final assessment is conducted to evaluate the overall response to the therapy.
Participants may be asked to undergo additional biopsies or imaging tests to gather more information about the treatment's effectiveness.

Who can join the trial?

18 criteria

Provide signed and dated informed consent to participate in the study.
Have a life expectancy of more than 3 months, as determined by the doctor.
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Have adequate organ function, which includes:
- Bone marrow function: enough red blood cells, platelets, and white blood cells.
- Liver function: specific liver enzymes and bilirubin levels should be within acceptable limits.
- Kidney function: creatinine levels should be within acceptable limits, or creatinine clearance should be adequate.
- Normal blood clotting function, with no signs of abnormal clotting or bleeding issues.
- All side effects from previous cancer treatments should have improved to a mild level, except for hair loss and mild nerve damage.
- If you have type II diabetes and take metformin, it must be replaced with another diabetes medication before starting the study treatment.
- Women who can have children must have a negative pregnancy test before starting the study treatment.
- All participants and their partners who can have children must agree to use highly effective birth control methods during the study and for at least 5 months after the last dose of the study drug.
- Be 18 years of age or older.
- For Spain: Have a confirmed diagnosis of advanced-stage, relapsed, or refractory solid tumors that cannot be cured. For Germany: Have a confirmed diagnosis of advanced-stage, relapsed, or refractory solid tumors that cannot be cured and have no other treatment options available.
- For Part A: Must have received at least one anti-PD-1/PD-L1 treatment and experienced disease progression or relapse after the treatment. For Part B: Must meet specific cancer type criteria and have received prior anti-PD-1/PD-L1 treatment, or have specific types of colorectal cancer without prior anti-PD-1/PD-L1 treatment.
- Be able to understand the study's purpose, provide informed consent, and comply with study procedures.
- For Part A: Ideally, about 50% of participants should have increased GDF-15 serum levels.
- For Spain: Must have tumors that can be biopsied and be willing to undergo biopsies. For Germany: Must have tumors that can be biopsied and be willing to undergo biopsies. Biopsies are mandatory unless deemed unsafe by the doctor.
- For Part B: Must have measurable disease at baseline that can be accurately measured using imaging techniques.
- Have an ECOG performance status of 0-1, which indicates the ability to carry out daily activities with minimal or no assistance.

Who cannot join the trial?

6 criteria

Patients who have a different type of cancer than those specified in the study.
Patients who have not relapsed or are not refractory to prior treatments as required by the study.
Patients who have not exhausted all available standard treatments or are still eligible for them.
Patients who have received prior anti-PD-1/PD-L1 therapy when not allowed by the study.
Patients with uveal/ocular melanoma, as only cutaneous and mucosal forms are included.
Patients who are part of a vulnerable population, as the study does not include them.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Goethe University Frankfurt
Frankfurt, Germany
Verified
Hestia Duran I Reynals
L'hospitalet De Llobregat, Spain
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

CTL-002
is an experimental medication being tested for its ability to fight cancer. It is given through an intravenous infusion, which means it is delivered directly into the bloodstream. This medication is being studied to see if it can help treat advanced-stage solid tumors that have not responded to other treatments.
Anti-PD-1 Checkpoint Inhibitor
is a type of medication that helps the immune system recognize and attack cancer cells. It works by blocking a specific protein on the surface of immune cells, which can help the immune system better target and destroy cancer cells. In this trial, it is used in combination with CTL-002 to see if the two medications together can improve treatment outcomes for patients with certain types of cancer.

What is already known about the treatment

CTL-002 – CTL-002 is administered intravenously and is currently being studied in clinical trials for its potential use in treating advanced-stage, relapsed, or refractory solid tumors. The medication is in the early stages of clinical research, specifically in a Phase 1/2 trial, and is not yet approved for general medical use. It is being investigated for its ability to work alone or in combination with an anti-PD-1 checkpoint inhibitor, targeting cancers such as bladder, hepatocellular, non-small cell lung, and certain types of melanoma, among others. CTL-002 is classified as an investigational drug, and its mechanism of action involves modulating the immune system to enhance its ability to fight cancer cells.

Investigated diseases

Bladder Cancer
This is a type of cancer that begins in the cells of the bladder, the organ responsible for storing urine. It often starts in the urothelial cells that line the inside of the bladder. As it progresses, it can invade deeper layers of the bladder wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include blood in the urine, frequent urination, and pain during urination. The disease can vary in severity, with some cases remaining superficial while others become invasive.
Hepatocellular Carcinoma
This is the most common type of primary liver cancer, originating in the liver cells known as hepatocytes. It often develops in the context of chronic liver disease, such as cirrhosis or hepatitis. As the disease progresses, it can lead to symptoms like abdominal pain, weight loss, and jaundice. The cancer can grow and spread to other parts of the body, including the lungs and bones. Early stages may not present noticeable symptoms, making it challenging to detect without screening.
Non-Small Cell Lung Cancer
This is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. Symptoms can include a persistent cough, chest pain, and shortness of breath. As the disease advances, it may spread to other parts of the body, such as the brain and bones. The progression can vary significantly depending on the subtype and stage at diagnosis.
Cutaneous Squamous Cell Carcinoma
This is a common form of skin cancer that arises from the squamous cells in the outer layer of the skin. It often appears as a red, scaly patch, open sore, or wart-like growth that may crust or bleed. The cancer can grow slowly but has the potential to spread to other parts of the body if not treated. It is more likely to occur in areas frequently exposed to sunlight, such as the face, ears, and hands. Early detection and treatment are crucial to prevent further progression.
Melanoma
This is a serious form of skin cancer that develops in the melanocytes, the cells responsible for producing pigment. It can occur on any skin surface but is more common in areas exposed to the sun. Melanoma can spread quickly to other parts of the body, including the lymph nodes and internal organs. Early signs include changes in the size, shape, or color of a mole. The disease can be aggressive, making early detection and monitoring essential.
Colorectal Cancer
This cancer affects the colon or rectum and is often grouped together due to their similarities. It typically begins as a growth called a polyp on the inner lining of the colon or rectum, which can become cancerous over time. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. As it progresses, the cancer can invade deeper layers of the colon or rectum and spread to other organs. Regular screening is important for early detection and prevention.