Not recruiting

Study of RLY-4008 for Patients with Cholangiocarcinoma and Other Advanced Solid Tumors

Verified siteInvestigationalNo placebo

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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 a type of cancer called cholangiocarcinoma, which is a cancer of the bile ducts, as well as other advanced solid tumors. The treatment being tested is a new medication known as RLY-4008, which is taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of RLY-4008 in patients with these conditions.

The study is divided into several parts. Initially, the trial will determine the best dose of RLY-4008 and assess how well patients tolerate it. In later stages, the study will focus on how effective the medication is in treating the cancers by observing the response of the tumors to the treatment. Throughout the study, the safety of the medication will be closely monitored to understand any side effects that may occur.

Participants in the trial will take the medication orally, and their health will be regularly checked by medical professionals. The study aims to provide valuable information about RLY-4008 and its potential as a treatment option for patients with cholangiocarcinoma and other advanced solid tumors. The trial is expected to continue until the end of 2025.

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
Introduction to the study
Upon joining the study, the patient will receive an overview of the trial's purpose and structure. The study is designed to evaluate the effects of a new medication, RLY-4008, in patients with intrahepatic cholangiocarcinoma and other advanced solid tumors.
Step 2
Medication administration
The patient will be administered RLY-4008 in the form of a capsule. The medication is taken orally. The specific dosage and frequency will be determined based on the study's phase and the patient's individual response.
Step 3
Monitoring and assessments
Throughout the trial, the patient will undergo regular monitoring to assess the safety and effectiveness of RLY-4008. This includes evaluating the medication's impact on the patient's condition and any potential side effects.
The study will also involve measuring various parameters such as the concentration of the medication in the blood and its effects on specific markers related to the disease.
Step 4
Evaluation of response
The patient's response to RLY-4008 will be evaluated using established criteria. This includes assessing the objective response rate, which measures how well the tumor responds to the treatment.
The duration of the response and overall disease control will also be monitored to determine the medication's effectiveness over time.
Step 5
Completion of the study
The study is expected to conclude by December 31, 2025. Upon completion, the patient will receive a summary of their participation and any relevant findings related to their treatment with RLY-4008.

Who can join the trial?

4 criteria

The study is for people with **Cholangiocarcinoma (CCA)**, which is a type of cancer that forms in the bile ducts, or other advanced solid tumors, which are large masses of tissue that can be cancerous.
Both **men and women** can participate in the study.
The study is open to adults, which means participants must be at least 18 years old.
The study is not designed for vulnerable populations, meaning it is not intended for groups that might need special protection or care.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer than the ones being studied, which are Cholangiocarcinoma (a type of bile duct cancer) and other advanced solid tumors.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition or are taking any medication that might interfere with the study treatment.
Patients who have had another cancer treatment recently that might affect the study results.
Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
Patients who have a history of allergic reactions to similar treatments or any of the ingredients in the study medication.
Patients who have a serious medical condition that might make it unsafe for them to participate in the study.

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Verified sites

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Verified
Centr Georges Francois Leclerc
Dijon, France
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

RLY-4008 is a highly selective inhibitor designed to target FGFR2, a protein that can be involved in the growth of certain types of cancer cells. This medication is being studied for its potential to treat patients with intrahepatic cholangiocarcinoma, a type of liver cancer, as well as other advanced solid tumors. The trial aims to determine the maximum tolerated dose and the recommended dose for further studies. It also evaluates the safety, tolerability, and effectiveness of RLY-4008 in shrinking tumors or stopping their growth.

Rly-4008

What is already known about the treatment

RLY-4008 – This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating intrahepatic cholangiocarcinoma and other advanced solid tumors. It is a highly selective FGFR2 inhibitor, which means it targets and blocks the activity of the FGFR2 protein that can contribute to cancer cell growth. The main therapeutic indication for RLY-4008 is to treat certain types of cancer by inhibiting this specific protein pathway. As a targeted therapy, it falls under the pharmacological classification of kinase inhibitors. The clinical trials aim to determine the maximum tolerated dose, recommended phase 2 dose, and overall safety and efficacy of the medication.

Investigated diseases

Cholangiocarcinoma
Cholangiocarcinoma is a type of cancer that forms in the bile ducts, which are the tubes that carry bile from the liver to the gallbladder and small intestine. It often begins in the cells lining the bile ducts and can occur anywhere along these ducts. The disease may cause symptoms such as jaundice, abdominal pain, and weight loss as it progresses. It is typically classified based on its location as intrahepatic, perihilar, or distal cholangiocarcinoma. The progression of the disease can lead to the obstruction of bile flow, causing further complications.
Advanced Solid Tumors
Advanced solid tumors refer to a group of cancers that have formed solid masses in various organs or tissues and have progressed to an advanced stage. These tumors can occur in different parts of the body, such as the lungs, breast, prostate, or colon. As they grow, they may invade nearby tissues and spread to other parts of the body, a process known as metastasis. Symptoms vary depending on the tumor's location and size but may include pain, swelling, or organ dysfunction. The progression of these tumors can lead to significant health challenges as they affect the normal function of the affected organs.