OncoMatch/Clinical Trials/NCT03886662
A Study of LB-100 in Patients With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)
Is NCT03886662 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies LB-100 for myelodysplastic syndromes.
Treatment: LB-100 — The purpose of this study is to test the safety and efficacy (benefits) of an investigational drug LB-100, for treatment of myelodysplastic syndromes. LB-100 has previously been administered to patients with various solid tumors. In this study, LB-100 will be administered as an intravenous infusion over 120 minutes. This study will be conducted in 2 phases. In phase Ib, escalating doses of LB-100 will be administered to patients to study the safety and to determine a safe dose of LB-100. In phase 2, patients will be administered LB-100 at the dose that was found to be safe in phase Ib. The efficacy (benefits) and safety of LB-100 will be determined in this phase of the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage LOW, INT-1
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: lenalidomide (lenalidomide) — del(5q) MDS
For del(5q) patients, failed prior treatment with at least 2 cycles started of lenalidomide defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy
Must have received: hypomethylating agent (azacitidine, decitabine) — non-del(5q) MDS
For non-del(5q) patients, failed prior treatment with at least 2 cycles started of azacitidine or decitabine or lenalidomide defined as no response to treatment, loss of response at any time point while on treatment or within 6 months of treatment discontinuation, or progressive disease/intolerance to therapy
Must have received: lenalidomide (lenalidomide) — non-del(5q) MDS
For non-del(5q) patients, failed prior treatment with at least 2 cycles started of azacitidine or decitabine or lenalidomide defined as no response to treatment, loss of response at any time point while on treatment or within 6 months of treatment discontinuation, or progressive disease/intolerance to therapy
Cannot have received: chemotherapy or experimental agents for MDS
Exception: within 14 days of the first day of study drug treatment
Use of chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 14 days of the first day of study drug treatment
Lab requirements
Kidney function
Creatinine clearance (CrCl) ≥ 60ml/min
Liver function
Total serum bilirubin < 1.5 x ULN or ≤ 3.0 x ULN with direct bilirubin within normal range only in patients with well documented Gilbert's syndrome or hemolysis or who required regular blood transfusions; AST and ALT < 3.0 x ULN
Cardiac function
QTcF (Fridericia's correction formula) < 450 msec; no symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to enrollment, unstable angina pectoris, or serious uncontrolled cardiac arrhythmia
Patient has adequate organ function as defined by the following laboratory values: Creatinine clearance (CrCl) ≥ 60ml/min; Total serum bilirubin < 1.5 x ULN or ≤ 3.0 x ULN with direct bilirubin within normal range only in patients with well documented Gilbert's syndrome or hemolysis or who required regular blood transfusions; Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) < 3.0 x ULN. Cardiac: symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to enrollment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, QTcF ≥ 450 msec [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- H. Lee Moffitt Cancer Center & Research Institute · Tampa, Florida
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify