OncoMatch/Clinical Trials/NCT06378437
A Study of GLB-001 in Patients With Myeloid Malignancies
Is NCT06378437 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies GLB-001 for polycythemia vera.
Treatment: GLB-001 — Study GLB-001-02 is a phase 1, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary efficacy of GLB-001 in study participants with relapsed or refractory or intolerant myeloid malignancies including polycythemia vera (PV), essential thrombocythemia (ET), myelofibrosis (MF), lower-risk myelodysplastic syndrome (LR-MDS), higher-risk myelodysplastic syndromes (HR-MDS), and acute myeloid leukemia (AML). This study consists of 3 parts, dose escalation (Phase 1a), dose exploration (Phase 1b) and dose expansion (Phase 1c). Dose escalation (Phase 1a) and dose exploration (Phase 1b) will evaluate the safety, tolerability, PK, PD and preliminary efficacy of GLB-001, administered orally, in study participants with PV/ET, or study participants with MF/LR-MDS/HR-MDS/AML, respectively. Dose expansion (Phase 1c) will be followed to determine the relationships among dose, exposure, toxicity, tolerability and clinical activity, to identify minimally active dose, and to select the recommended dose(s) for phase 2 study. Approximately 108 study participants may be enrolled in the study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myeloproliferative Neoplasm
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: hydroxyurea (hydroxyurea)
PV or ET who received treatment with hydroxyurea within 2 days prior to the first dose
Cannot have received: any other treatment for PV or ET
any other treatment for PV or ET within 7 days prior to first dose of GLB-001
Cannot have received: any type of treatment for MF
MF who received any type of treatment for MF within 14 days prior to the first dose, such as chemotherapy, immunotherapy, radiotherapy and erythropoietin, androgens, thrombopoietin or granulocyte colony-stimulating factor
Cannot have received: any type of treatment for MDS
LR-MDS who received any type of treatment for MDS within 14 days prior to the first dose
Cannot have received: CAR-T cell therapy or other biologic therapy
HR-MDS or AML who received chimeric antigen receptor T cell therapy (CAR-T) or other biologic therapy within 28 days prior to the first dose of GLB-001
Cannot have received: any other anticancer therapies
HR-MDS or AML who ... received any other anticancer therapies within 14 days prior to the first dose of GLB-001
Cannot have received: any other investigational drug
Receipt of any other investigational drug study within 28 days or 5 half-lives of that study drug before the first dose of GLB-001
Cannot have received: autologous stem cell transplantation
Receipt of autologous stem cell transplantation (ASCT) within the last 3 months prior to the first dose of GLB-001
Cannot have received: allogeneic hematopoietic stem cell transplantation
allogeneic hematopoietic stem cell transplantation (allo-HSCT) within the last 6 months prior to the first dose of GLB-001
Lab requirements
Blood counts
Good performance of major organs, including hematology, liver and kidney function, and coagulation
Kidney function
Good performance of major organs, including hematology, liver and kidney function, and coagulation
Liver function
Good performance of major organs, including hematology, liver and kidney function, and coagulation
Cardiac function
QT interval > 450 ms; impaired cardiac function or clinically significant cardiac disease at current or within last 6 months
Good performance of major organs, including hematology, liver and kidney function, and coagulation. QT interval > 450 milliseconds (ms) using electrocardiographic (ECG) at screening. Impaired cardiac function or clinically significant cardiac disease at current or within last 6 months [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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