#1 Clinical Trials Search in Europe

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

This article discusses the ongoing clinical trials investigating the use of RVU120 (also known as SEL120 monohydrochloride) in treating various types of cancer. RVU120 is a novel drug being tested for its potential in treating acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myelofibrosis, and advanced solid tumors. These trials aim to evaluate the safety, efficacy, and optimal dosing of RVU120 in patients who have not responded well to standard treatments or have limited treatment options available.

Table of Contents

Introduction

RVU120, also known as SEL120 monohydrochloride, is an investigational drug currently being studied for the treatment of various blood cancers and solid tumors. This article will provide an overview of RVU120, its potential uses, and the ongoing clinical trials evaluating its safety and effectiveness.[1][2][3][4][5]

What is RVU120?

RVU120 is a novel drug being developed by Ryvu Therapeutics S.A. Its chemical name is 7,8-dibromo-5,6-dihydro-9-methyl-2-(1-piperazinyl)-4H-imidazo[4,5,1-ij]quinoline hydrochloride. It is classified as a small-molecule anticancer drug and specifically acts as a CDK8 kinase inhibitor. CDK8 is an enzyme involved in cell growth and division, and by inhibiting it, RVU120 may help slow or stop the growth of cancer cells.[1][3]

What Conditions Does RVU120 Treat?

RVU120 is being investigated for the treatment of several types of cancer, including:

  • Acute Myeloid Leukemia (AML): A type of blood cancer that affects the bone marrow and blood.[1][2]
  • Myelodysplastic Syndrome (MDS): A group of disorders where blood cells don’t mature properly in the bone marrow.[1][3]
  • Myelofibrosis: A rare type of blood cancer that affects the bone marrow.[4]
  • Advanced Solid Tumors: Various types of cancers that form solid masses in the body.[5]

The drug is being studied in patients who have relapsed or become resistant to other treatments, offering hope for those who have exhausted standard treatment options.[1][2][5]

How Does RVU120 Work?

RVU120 works by inhibiting CDK8, a protein kinase that plays a role in regulating gene expression and cell division. By blocking CDK8, RVU120 may help to:

  • Slow or stop the growth of cancer cells
  • Promote the death of cancer cells
  • Reduce the spread of cancer to other parts of the body

This mechanism of action is different from many existing cancer treatments, which is why RVU120 is being studied in patients who have not responded well to other therapies.[1][3]

Current Clinical Trials

Several clinical trials are currently underway to evaluate the safety and effectiveness of RVU120:

  • RIVER-52 Trial: This study is testing RVU120 in patients with relapsed or refractory high-risk MDS or AML.[1]
  • RIVER-81 Trial: This trial is investigating RVU120 in combination with venetoclax for AML patients who have failed prior therapy.[2]
  • MDS Anemia Trial: This study is evaluating RVU120 for the treatment of anemia in patients with lower-risk MDS.[3]
  • POTAMI-61 Trial: This trial is testing RVU120 alone and in combination with ruxolitinib for patients with myelofibrosis.[4]
  • Solid Tumor Trial: This study is investigating RVU120 in patients with advanced solid tumors who have failed standard treatments.[5]

Potential Benefits

While research is still ongoing, RVU120 shows promise in several areas:

  • Potential to treat cancers that have become resistant to other therapies
  • May improve blood cell counts in patients with blood cancers
  • Could reduce the size of tumors or slow their growth
  • Might improve quality of life for patients with cancer-related symptoms

However, it’s important to note that these potential benefits are still being studied and have not yet been proven in large clinical trials.[1][3][4]

Possible Side Effects

As with all medications, RVU120 may cause side effects. The full range of potential side effects is still being determined through clinical trials. Some possible side effects being monitored include:

  • Changes in blood cell counts
  • Gastrointestinal issues (nausea, vomiting, diarrhea)
  • Fatigue
  • Liver function changes
  • Cardiac effects (changes in heart rhythm)

It’s important to remember that not all patients will experience these side effects, and the severity can vary. The clinical trials are carefully monitoring patients for any adverse effects to ensure the safety of the treatment.[1][2][5]

Conclusion

RVU120 represents a promising new approach in the treatment of various blood cancers and solid tumors. While still in the investigational stage, it offers hope for patients who have not responded well to existing therapies. Ongoing clinical trials will provide more information about its effectiveness and safety profile. As with any experimental treatment, patients should discuss the potential risks and benefits with their healthcare providers to determine if participating in a clinical trial might be appropriate for their individual situation.

Trial Number Cancer Type Phase Main Objectives Key Eligibility Criteria
2023-505910-10-00 AML and high-risk MDS Not specified Estimate anti-tumor activity, evaluate clinical benefit, characterize safety and PK Adults with relapsed/refractory AML or high-risk MDS, ECOG 0-2
2023-505911-19-00 AML Not specified Determine recommended dose, evaluate anti-leukemic activity, assess safety and PK Adults with AML who failed prior venetoclax and hypomethylating agent therapy
2023-509947-29-00 Lower-risk MDS II Evaluate erythroid response, assess efficacy and safety Adults with very low, low, or intermediate risk MDS with anemia
2024-511688-27-00 Myelofibrosis Not specified Evaluate anti-cancer activity, assess safety and PK, measure symptom burden changes Adults with intermediate or high-risk primary or secondary myelofibrosis
2024-515131-30-00 Advanced solid tumors I/II Characterize safety and tolerability, explore anti-tumor activity, determine PK profile Adults with relapsed/refractory metastatic or advanced solid tumors who have exhausted standard treatments

FAQ

  • What is RVU120 and how does it work? RVU120 is an investigational drug that works as a CDK8 and CDK19 kinase inhibitor. It is designed to target specific cellular processes involved in cancer growth and progression. The exact mechanism is still being studied in these clinical trials.
  • What types of cancer is RVU120 being tested for? RVU120 is currently being tested in clinical trials for acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myelofibrosis, and various advanced solid tumors that have not responded well to standard treatments.
  • Who is eligible to participate in these clinical trials? Eligibility varies by trial, but generally includes adult patients with specific cancer types who have not responded to or are not eligible for standard treatments. Patients must meet certain health criteria and be willing to comply with study procedures.
  • What are the main goals of these clinical trials? The main goals are to evaluate the safety and effectiveness of RVU120, determine the optimal dosing, assess how the body processes the drug (pharmacokinetics), and measure its impact on cancer symptoms and quality of life for patients.
  • Are there any known side effects of RVU120? As RVU120 is still in clinical trials, all potential side effects are not yet known. The trials are designed to carefully monitor and document any adverse events. Patients are closely observed for any unexpected reactions or side effects throughout the study.

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

  • Study of RVU120 treatment in patients with myelodysplastic syndrome, solid tumors, or acute myeloid leukemia who benefited from previous RVU120 therapy

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Poland Spain

  • Study on RVU120 and Venetoclax for Patients with Acute Myeloid Leukemia After Previous Treatment Failure

    Recruiting

    2 1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Poland Spain

  • A study of RVU120 and everolimus for children with recurrent or progressive medulloblastoma

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

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

    Not recruiting

    2 1 1 1
    Investigated drugs:
    Poland Spain

  • Study of RVU120 and Ruxolitinib for Patients with Intermediate or High-Risk Myelofibrosis

    Not recruiting

    2 1 1 1 1
    Investigated drugs:
    Italy Poland

  • Study of SEL120 Monohydrochloride for Treating Anemia in Patients with Lower-Risk Myelodysplastic Syndromes (MDS)

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy Poland Spain

  • Study of RVU120 for Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

    Not recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Poland Spain

Glossary

  • Acute Myeloid Leukemia (AML): A type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells that interfere with the production of normal blood cells.
  • Myelodysplastic Syndrome (MDS): A group of disorders caused by poorly formed or dysfunctional blood cells, which can lead to anemia, infections, or easy bleeding and can potentially progress to acute myeloid leukemia.
  • Myelofibrosis: A rare type of blood cancer where the bone marrow is replaced by scar tissue, leading to abnormal blood cell production and an enlarged spleen.
  • CDK8 and CDK19 kinase inhibitor: A type of drug that blocks the action of specific enzymes (CDK8 and CDK19) involved in cell division and growth, potentially slowing or stopping the growth of cancer cells.
  • Pharmacokinetics (PK): The study of how a drug is absorbed, distributed, metabolized, and eliminated by the body over time.
  • Spleen Volume Reduction (SVR): A measure of how much the spleen size decreases, often used as an indicator of treatment effectiveness in certain blood cancers like myelofibrosis.
  • RECIST criteria: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment based on the size of tumors.
  • Erythroid response (HI-E): An improvement in red blood cell production or function, often used as a measure of treatment effectiveness in blood disorders.
  • QTc interval: A measurement on an electrocardiogram that represents the time it takes for the heart's electrical system to recharge between beats, which can be affected by certain medications.
  • Bone marrow fibrosis: A condition where the soft, spongy tissue inside bones becomes scarred, affecting normal blood cell production.

References

  1. http://clinicaltrials.eu/trial/study-of-rvu120-for-patients-with-relapsed-or-refractory-high-risk-myelodysplastic-syndrome-or-acute-myeloid-leukemia/
  2. http://clinicaltrials.eu/trial/study-on-rvu120-and-venetoclax-for-patients-with-acute-myeloid-leukemia-after-previous-treatment-failure/
  3. http://clinicaltrials.eu/trial/study-of-sel120-monohydrochloride-for-treating-anemia-in-patients-with-lower-risk-myelodysplastic-syndromes-mds/
  4. http://clinicaltrials.eu/trial/study-of-rvu120-and-ruxolitinib-for-patients-with-intermediate-or-high-risk-myelofibrosis/
  5. http://clinicaltrials.eu/trial/study-of-rvu120-for-patients-with-advanced-solid-tumors-after-standard-treatments-have-failed/