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CDK8/19 Inhibitor

RVU120 for Leukemia and Myelodysplastic Syndrome

Phase 1

Waitlist Available

Research Sponsored by Ryvu Therapeutics SA

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

AML diagnosis according to the 2016 World Health Organisation (WHO) classification (Arber et al. 2016) with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care; or Myelodysplastic Syndrome (MDS) diagnosis according to the 2016 WHO classification (Arber et al. 2016) with high-risk disease per the Revised International Prognostic Scoring System (IPSS-R >4.5) and with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care

Age ≥18 years

Must not have

Known positive test of / or known active diagnosis of COVID-19 viral infection

Active acute graft versus host disease (GVHD)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug for leukemia and myelodysplastic syndrome to see if it is safe and effective.

Who is the study for?

Adults over 18 with Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome who have tried all standard treatments without success. They must be in good general health, not pregnant, willing to use contraception, and not have certain heart conditions or other serious medical issues.

What is being tested?

The trial is testing RVU120 (SEL120), a new drug aimed at inhibiting specific enzymes involved in cancer cell growth. It's for patients whose leukemia or syndrome hasn't responded to other treatments, assessing the best dose for future studies and its safety and effectiveness.

What are the potential side effects?

Possible side effects of RVU120 are not detailed here but may include typical reactions related to cancer drugs such as fatigue, nausea, blood count changes, liver function alterations, and potential heart rhythm problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have AML or MDS with no treatment options left.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I currently have or recently tested positive for COVID-19.

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I am currently experiencing symptoms of acute graft versus host disease.

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I am not taking medication known to affect heart rhythm.

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My leukemia has spread to my brain or spinal cord.

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I have been treated with CDK8-targeted therapy before.

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I have serious heart problems or chest pain that is not well managed.

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I am currently experiencing lung inflammation due to medication.

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I have a digestive system condition.

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I have a serious liver condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Adverse Events (Safety and Tolerability)

Recommended dose (RD)

Secondary study objectives

Anti-leukemic activity

The Area Under the Curve (AUC)

The Maximum Observed Concentration (C[max])

+2 more

Other study objectives

AML surface markers

Genetic profile changes in AML blasts

Phosphorylated protein levels in AML blasts

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: RVU120(SEL120)Experimental Treatment1 Intervention

The first part of the study consists of dose-escalation cohorts where patients will receive ascending doses of RVU120(SEL120) to determine the recommended dose (RD) for further clinical development. The second part of the study is an enrichment cohort where additional 6 to 20 patients will be treated with RVU120(SEL120) to support the evaluation of the RD.

0 / 12Eligibility criteria met