A Clinical Study of HMPL-506 in Patients With Hematological Malignancies

Recruiting now · Phase 1

Conditions studied: Hematological Malignancies

In brief

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.

Key facts

Study ID

NCT06387082

Run by

Hutchmed

People needed

132

Starts

2024-05-27

Expected to finish

2027-12-08

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must meet all of the following criteria to be eligible for enrolment.
• Having understood this study adequately and being voluntary to sign the ICF;
• Age ≥18 years;
• 1) Dose escalation phase: patient with MLL-rearranged and/or NPM1-mutant relapsed/refractory AML or ALL (confirmed as per the 2022 World Health Organization (WHO) Classification of Myeloid Neoplasms and Acute Leukemia): 2) Dose expansion phase: approximately 10 to 20 patients will be enrolled in each of the following cohorts
• MLL-rearranged and/or NPM1-mutant relapsed/refractory AML
• MLL-rearranged relapsed/refractory ALL
• Relapsed/refractory MM (which can be screened and enrolled without biomarker testing), and AML harboring genetic alterations such as NUP214 or NUP98 fusion
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2;
• Agree to undergo bone marrow aspiration and/or biopsy before and during treatment;
• Women patients of childbearing potential must agree to use highly effective contraceptive methods from screening until 30 days after discontinuation of study treatment, and their male partners must use condoms. See Appendix 11 (Definition of Women of Childbearing Potential [WOCBP] and Acceptable and Unacceptable Contraceptive Methods) for more details. And women patients of childbearing potential should agree not to donate eggs (or oocytes) for reproductive purposes during this period.
• Male patients with a female partner of childbearing potential must agree to use condoms when having intercourse during the study and within 30 days after discontinuation of the investigational product. Patients should avoid sperm donation or freezing of sperm during the study and within 30 days after discontinuation of the investigational product.

You may not qualify if…

• Subjects will be excluded from this study project if they meet any of the following criteria:
• Patients who have previously received treatment with menin inhibitors and experienced progression during treatment;
• Patients with definite active central nervous system (CNS) leukemia (prior CNS leukemia has been treated and controlled, but a cerebrospinal fluid test through lumbar puncture is required at screening to confirm the absence of CNS involvement);
• Serum total bilirubin (TBIL) > 1.5 × the upper limit of normal (ULN), with the exception of the following patients:
• Patients with Gilbert's disease, with normal alanine aminotransferase (ALT) and aspartate aminotransferase (AST), and serum TBIL ≤ 3 × ULN
• ALT or AST > 3 × ULN in the absence of liver involvement with leukemia or ALT or AST > 5 × ULN in the presence of liver involvement with leukemia (the latter criterion is not applicable in the dose escalation phase);
• Glomerular filtration rate or creatinine clearance estimated using Cockcroft-Gault formula < 50 mL/min.
• International normalized ratio (INR) > 1.5 × ULN or activated partial thromboplastin time (aPTT) > 1.5 × ULN; this criterion is not applicable in patients who are receiving anticoagulant therapy.
• Known history of clinically significant liver disease, including viral hepatitis or other types of hepatitis:
• Patients with hepatitis B (HBV) (HBsAg or HBcAb positive) can be enrolled if they test negative for HBV DNA by PCR, but the HBV DNA test should be performed every cycle
• Patients with hepatitis C (HCV) can be enrolled if they test negative for HCV RNA by PCR.
• Known human immunodeficiency virus (HIV) infection.
• Women who are pregnant (with a positive pregnancy test before administration) or breastfeeding.
• History of stroke or intracranial hemorrhage within 6 months prior to the first dose of the investigational product.
• Patients with other primary malignancies within the last 5 years, but patients with the following non-invasive tumors that have been treated with curative intent are exceptions: basal cell carcinoma of skin, squamous cell carcinoma of skin, in situ carcinoma of cervix and breast cancer in situ.
• Patients who meet any of the following cardiac function-related criteria:
• Any clinically significant abnormal heart rhythm or conduction requiring clinical intervention.
• Hereditary long QT syndrome or QTcF > 470 msec.
• Clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting within 6 months prior to enrollment, New York Heart Association (NYHA) Class III or above congestive heart failure, left ventricular ejection fraction (LVEF) < 50%, or uncontrolled hypertension (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg), or mean heart rate > 100 beats/min on triplicate electrocardiograms (ECGs) at screening.
• Receipt of systemic anti-tumor therapy or radiotherapy within 2 weeks prior to initiation of study treatment:
• For patients with increased peripheral white blood cell count (WBC > 25 × 109/L), use of hydroxycarbamide is allowed to control peripheral WBC before enrollment and during HMPL-506 treatment.
• Prophylactic intrathecal injection of chemotherapy drugs (cytarabine, dexamethasone and methotrexate) to prevent CNS leukemia is 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):
• Patients who use fixed-dose oral glucocorticoids and/or topical glucocorticoids for the treatment of skin GVHD can be enrolled.
• 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.

Where it is running

• Henan Cancer Hospital — Zhengzhou, China (enrolling)
• First Affiliated Hospital of Chongqing Medical University — Chongqing, China (enrolling)
• Tianjin People's Hospital — Tianjin, China (enrolling)
• Wuhan Union Hospital of China — Wuhan, China (enrolling)
• Xiangya Hospital of Central South University — Changsha, China (enrolling)
• Nanfang Hospital, Southern Medical University — Guangzhou, China (enrolling)
• The First Affiliated Hospital, Zhejiang University — Hangzhou, China (enrolling)
• Anhui Provincial Hospital — Hefei, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, China (enrolling)
• The First Affiliated Hospital with Nanjing Medical University — Nanjing, China (enrolling)
• Shengjing Hospital of China Medical University — Shenyang, China (enrolling)
• The First Affiliated Hospital of Soochow University — Suzhou, China (enrolling)
• Blood Diseases Hospital, Chinese Academy of medical Sciences — Tianjin, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, China
• The Affiliated Hospital of Guizhou Medical University — Guiyang, China
• Sun Yat-sen University Cancer Center — Guangzhou, China

Full record on ClinicalTrials.gov

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