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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

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
Centr Georges Francois Leclerc Dijon France
Medizinische Hochschule Hannover Hanover Germany
Hospital Universitario Hm Sanchinarro Madrid Spain
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Hospital Universitario De Navarra Pamplona Spain

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
Netherlands Cancer Institute Amsterdam The Netherlands
Cgpjpu Lfru Bjcrap Lyon France
Ecwhjws Uimdtqbeaika Mjmuibq Cavgwxn Rqvnbphfd (ogiznyh Mzl Rotterdam The Netherlands
Kspvhaio dso Uuvumzflylji Mnvzhbkt Aqr Munich Germany
Hwhfukre Vjig dyldbjau Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
13.09.2021
Germany Germany
Not recruiting
13.09.2021
Spain Spain
Not recruiting
13.09.2021
Sweden Sweden
Not recruiting
13.09.2021
The Netherlands The Netherlands
Not recruiting
13.09.2021

Trial locations

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.

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.

Trial ID:
2024-512622-29-00
Protocol code:
RLY-4008-101
NCT ID:
NCT04526106
Trial Phase:
Phase I and Phase II (Integrated) – First administration to humans

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