Study of RVU120 for Patients with Advanced Solid Tumors After Standard Treatments Have Failed

2 1 1 1

What is this study about?

This clinical trial is focused on studying the effects of a new treatment called RVU120 (SEL120) for patients with advanced solid tumors. These are types of cancer that have spread or returned after previous treatments. The trial aims to understand how safe and tolerable the treatment is and to explore its potential benefits in fighting these tumors.

The study involves taking RVU120 in the form of capsules. Participants will receive this treatment over a period of time, with the goal of determining the best dose and observing any effects on the tumors. The trial is divided into two parts: the first part focuses on finding the right dose, while the second part looks at the treatment’s effectiveness in specific types of tumors.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how the treatment affects their condition. The trial will help researchers learn more about RVU120 and its potential as a treatment option for people with advanced solid tumors who have not had success with standard therapies.

1 joining the study

Upon joining the study, the patient will be required to provide written, informed consent. This consent confirms understanding of the study procedures and the ability to withdraw at any time without prejudice.

A screening process will be conducted to ensure eligibility, including laboratory tests and a tumor biopsy sample.

2 initial treatment phase

The patient will begin treatment with SEL120 monohydrochloride, administered orally in capsule form.

The dosage and frequency will be determined based on the specific phase of the trial and the patient’s condition.

3 dose escalation (phase I)

In this phase, the safety and tolerability of RVU120 will be assessed. The dosage may be adjusted to find the most effective and safe dose.

The patient will be monitored for any side effects or adverse reactions.

4 safety expansion and efficacy evaluation (phase II)

The patient will continue to receive RVU120 to further evaluate its safety and effectiveness.

The focus will be on observing the anti-tumor activity and any changes in the patient’s condition.

5 ongoing monitoring

Throughout the trial, the patient will undergo regular assessments to monitor health status and response to treatment.

These assessments may include physical exams, imaging tests, and laboratory evaluations.

6 completion of the trial

Upon completion of the trial, the patient will have a final evaluation to assess overall health and any long-term effects of the treatment.

The patient will be informed of any follow-up care or additional studies that may be necessary.

Who Can Join the Study?

Must be 18 years or older.
Must have certain blood test results within specific ranges, such as:
- Enough neutrophils, a type of white blood cell, without extra help.
- Enough platelets, which help with blood clotting.
- Enough hemoglobin, which carries oxygen in the blood, without recent blood transfusions.
- Enough serum albumin, a protein in the blood.
- Bilirubin levels, a substance made by the liver, must be below a certain level.
- Liver enzymes (AST and ALT) must be below a certain level, with some exceptions for liver issues.
- Creatinine clearance, a measure of kidney function, must be above a certain level.
- Normal blood clotting ability.
Heart function must be above a certain level, measured by a test like an echocardiogram.
Must be able to provide a tumor biopsy sample, which is a small piece of the tumor for testing.
Women who can have children must have a negative pregnancy test and use effective birth control during the study and for 6 months after.
Men must use effective birth control if their partner can have children and avoid donating sperm during the study and for 6 months after.
Must be able to give written consent to participate and understand the study requirements.
Must have stopped any previous cancer treatments for a certain period before starting the study.
Must have advanced or metastatic tumors that have not responded to standard treatments.
Must have at least one measurable or evaluable disease according to specific criteria.
Must have a performance status that shows they can carry out daily activities, rated 0-2 on a specific scale.
Must have an estimated life expectancy of at least 12 weeks.
Any side effects from previous cancer treatments must be mild, except for certain conditions like hair loss or mild nerve issues.
Must have a 4-week gap between the last radiation treatment and the start of the study, with some exceptions.
Must have recovered from major surgery, with only mild ongoing effects.
Must be at least 2 weeks off high-dose steroids, but low doses are allowed.

Who Cannot Join the Study?

Patients who have not recovered from previous treatments or surgeries.
Patients with other serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures or attend required visits.
Patients who have participated in another clinical trial recently.
Patients with allergies to the study medication or similar drugs.
Patients with certain types of infections that are not well controlled.
Patients with a history of certain heart conditions.
Patients with a history of certain lung conditions.
Patients with a history of certain liver conditions.
Patients with a history of certain kidney conditions.
Patients with a history of certain blood disorders.
Patients with a history of certain neurological conditions.
Patients with a history of certain psychiatric conditions.
Patients with a history of substance abuse.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach	Katowice	Poland

Other Sites

Site Name	City	Country
Hospital Quironsalud Barcelona	Barcelona	Spain
Beskidzkie Centrum Onkologii Szpital Miejski Im. Jana Pawla II W Bielsku-Bialej SPZOZ	Bielsko-Biala	Poland
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland
Hospital Vall d’Hebron	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	13.08.2021
Spain	Not recruiting	13.08.2021

Trial locations

Investigated drugs:

7,8-Dibromo-5,6-Dihydro-9-Methyl-2-(1-Piperazinyl)-4H-Imidazo[4,5,1-Ij]Quinoline Hydrochloride

RVU120 is a medication being studied for its potential to treat patients with advanced or metastatic solid tumors that have not responded to previous treatments. The trial aims to assess the safety and tolerability of RVU120 when used alone. Researchers are also exploring its effectiveness in reducing or controlling tumor growth in patients with specific types of tumors.

Relapsed/Refractory Metastatic or Advanced Solid Tumors – These are cancers that have either returned after treatment (relapsed) or have not responded to treatment (refractory). They are characterized by the spread of cancer cells from the original site to other parts of the body (metastatic) or by being in an advanced stage where the cancer is more widespread. The progression of these tumors can vary greatly depending on the type of cancer and its location. They often grow and spread more aggressively, making them challenging to manage. The behavior of these tumors can lead to various symptoms depending on the organs affected. Understanding their progression is crucial for developing effective treatment strategies.

Trial ID:

2024-515131-30-00

Protocol code:

RVU120-SOL-021

NCT ID:

NCT05052255

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of RVU120 for Patients with Advanced Solid Tumors After Standard Treatments Have Failed

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?