OncoMatch/Clinical Trials/NCT06387082
A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
Is NCT06387082 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies HMPL-506 for hematological malignancies.
Treatment: HMPL-506 — This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 132 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 72 patients in the dose expansion phase.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: KMT2A (MLL) rearrangement
Required: NPM1 mutation
Required: NUP214 fusion
Required: NUP98 fusion
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: menin inhibitor
Patients who have previously received treatment with menin inhibitors and experienced progression during treatment
Cannot have received: systemic anti-tumor therapy
Exception: hydroxycarbamide allowed for WBC control; prophylactic intrathecal cytarabine, dexamethasone, methotrexate allowed
Receipt of systemic anti-tumor therapy or radiotherapy within 2 weeks prior to initiation of study treatment
Cannot have received: hematopoietic stem cell transplant
Exception: fixed-dose oral/topical glucocorticoids for skin GVHD allowed
Patients who have received HSCT within 60 days before initiation of study treatment, or are receiving immunosuppressive therapy after HSCT at screening, or require medical intervention to control graft versus host disease (GVHD)
Cannot have received: herbal and traditional medicines/their active ingredients with anti-tumor activity
Patients who have received treatment with herbal and traditional medicines/their active ingredients with definite anti-tumor activity within 1 week before initiation of study treatment
Lab requirements
Blood counts
INR ≤ 1.5 × ULN or aPTT ≤ 1.5 × ULN (not applicable if on anticoagulant therapy)
Kidney function
Glomerular filtration rate or creatinine clearance (Cockcroft-Gault) ≥ 50 mL/min
Liver function
Serum total bilirubin (TBIL) ≤ 1.5 × ULN (≤ 3 × ULN for Gilbert's disease with normal ALT/AST); ALT or AST ≤ 3 × ULN (≤ 5 × ULN with liver involvement with leukemia, not applicable in dose escalation phase)
Cardiac function
No clinically significant abnormal heart rhythm or conduction; no hereditary long QT syndrome or QTcF > 470 msec; no acute MI, unstable angina, CABG within 6 months, NYHA Class III+ CHF, LVEF < 50%, uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg), or mean HR > 100 bpm on triplicate ECGs at screening
Serum total bilirubin (TBIL) > 1.5 × ULN, ALT or AST > 3 × ULN, GFR or creatinine clearance < 50 mL/min, INR > 1.5 × ULN or aPTT > 1.5 × ULN, cardiac function-related criteria as listed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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