RVU120 for Leukemia and Myelodysplastic Syndrome

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ryvu Therapeutics SA

No Placebo Group

Trial Summary

What is the purpose of this trial?This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the recommended dose for further clinical development and assessment of safety, tolerability, preliminary anti-leukemic activity, as well as pharmacokinetic and pharmacodynamic profiles.

Eligibility Criteria

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.

Inclusion Criteria

I have stopped all cancer treatments before joining this study.

Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula)

Investigator considers the patient to be suitable for participation in the clinical study

+15 more

Exclusion Criteria

I have been cancer-free for 5 years, except for AML or MDS.

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

Concurrent participation in another investigational clinical trial

+16 more

Participant Groups

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.

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.