OncoMatch/Clinical Trials/NCT05308264
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Is NCT05308264 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies R906289 Monosodium (R289 Na) for low risk myelodysplastic syndromes.
Treatment: R906289 Monosodium (R289 Na) — Phase 1b Study of R289 in Patients with Lower-risk Myelodysplastic Syndromes (LR MDS)
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage VERY LOW, LOW, INTERMEDIATE-1 (IPSS-R)
very low, low, or intermediate-1 risk (International Prognostic Scoring System (IPSS)-R ≤ 3.5) and ≤5% bone marrow myeloblasts
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: erythropoiesis-stimulating agent (EPO, luspatercept) — relapsed, refractory/resistant, intolerant, or inadequate response
Must be relapsed, refractory/resistant, intolerant, or have inadequate response to therapies with known clinical benefits for MDS, such as EPOs, luspatercept, and HMAs (i.e., azacytidine or decitabine)
Must have received: hypomethylating agent (azacytidine, decitabine) — relapsed, refractory/resistant, intolerant, or inadequate response
Must be relapsed, refractory/resistant, intolerant, or have inadequate response to therapies with known clinical benefits for MDS, such as EPOs, luspatercept, and HMAs (i.e., azacytidine or decitabine)
Must have received: immunomodulatory agent (lenalidomide) — failed prior therapy required for patients with del (5q)
Patients with del (5q) must have failed prior lenalidomide therapy
Cannot have received: erythropoiesis-stimulating agent (EPO, luspatercept)
Prior treatment for MDS (i.e., TPOs, EPOs, luspatercept, HMAs) concluded < 4 weeks prior to study treatment
Cannot have received: hypomethylating agent (azacytidine, decitabine)
Prior treatment for MDS (i.e., TPOs, EPOs, luspatercept, HMAs) concluded < 4 weeks prior to study treatment
Cannot have received: thrombopoietin receptor agonist (TPO)
Prior treatment for MDS (i.e., TPOs, EPOs, luspatercept, HMAs) concluded < 4 weeks prior to study treatment
Lab requirements
Kidney function
creatinine clearance > 60 mL/min (Cockcroft-Gault), or blood creatinine < 1.5 mg/dL
Liver function
AST and ALT ≤ 1.5 × ULN; total bilirubin ≤ 1.5 × ULN
adequate organ function, defined as: Hepatic function: AST and ALT ≤ 1.5 × ULN; total bilirubin ≤ 1.5 × ULN. Renal function: creatinine clearance > 60 mL/min (Cockcroft-Gault), or blood creatinine < 1.5 mg/dL
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of California, Los Angeles · Los Angeles, California
- University of California, Irvine · Orange, California
- Stanford Cancer Institute · Palo Alto, California
- University of Miami · Miami, Florida
- Mount Sinai Medical Center · Miami Beach, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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