NCT05308264

Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)

An Open-label, Phase 1b Study of R289, an IRAK1/4 Inhibitor, in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS) Who Are Relapsed/Refractory/Resistant to Prior Therapies

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)

Detailed description

An open-label, Phase 1b study of R289, an IRAK 1/4 Inhibitor, to determine tolerability and preliminary efficacy in patients with LR MDS who are relapsed/refractory/resistant, intolerant, or have inadequate response to prior therapies such as erythropoietin (EPO), luspatercept, or hypomethylating agents (HMAs) for MDS.

Conditions

• Low Risk Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	R906289 Monosodium (R289 Na)	Drug: R906289 Monosodium (R289 Na) R906289 Monosodium (250mg PO qd, 250mg PO bid, 500 mg PO qd, 500 mg PO bid, 750 mg PO qd, split dose - 500 mg PO AM/250 mg PO PM)

Timeline

• Start date: 2022-09-12
• Primary completion: 2026-08-01
• Completion: 2026-12-01
• First posted: 2022-04-04
• Last updated: 2025-10-21

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study