NCT04021368

RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

A Phase Ib Study of RVU120 (SEL120) in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Ryvu Therapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The study will determine the recommended phase II dose (RP2D) and safety of RVU120 (SEL120) given as monotherapy over a range of dose-levels, following a closely controlled dose escalation study design.

Conditions

• Acute Myeloid Leukemia
• High-risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	RVU120(SEL120)	RVU120(SEL120) will be administered as a single oral dose every other day (q.o.d.) for a total of 7 doses i.e. on Days 1, 3, 5, 7, 9, 11 and 13, in a 3-week treatment cycle.

Timeline

• Start date: 2019-09-04
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2019-07-16
• Last updated: 2024-02-14

Locations

10 sites across 2 countries: United States, Poland

Regulatory

• FDA-regulated drug study