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

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 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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

23 criteria

  • 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 trial?

15 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

RVU120 – RVU120 is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating relapsed or refractory metastatic or advanced solid tumors. It is in the early stages of research, specifically in Phase I/II trials, where its safety, tolerability, and anti-tumor activity are being evaluated. The main therapeutic indication for RVU120 is for patients with advanced solid tumors that have not responded to previous treatments. At the molecular level, RVU120 works by inhibiting specific enzymes that are involved in the growth and survival of cancer cells, potentially slowing down or stopping tumor progression. It is classified pharmacologically as a kinase inhibitor, targeting pathways that are crucial for cancer cell proliferation.

Investigated diseases

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 detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515131-30-00Protocol codeRVU120-SOL-021Estimated enrolment54 patientsSponsorRyvu Therapeutics S.A.

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