Actively Recruiting
A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
Led by Hutchmed · Updated on 2025-09-29
132
Participants Needed
16
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand the study and voluntarily sign the informed consent form
- Be 18 years of age or older
- For dose escalation: have MLL-rearranged and/or NPM1-mutant relapsed/refractory AML or ALL
- For dose expansion: belong to one of three cohorts: MLL-rearranged and/or NPM1-mutant relapsed/refractory AML; MLL-rearranged relapsed/refractory ALL; relapsed/refractory multiple myeloma or AML with NUP214 or NUP98 fusion
- Have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 2
- Agree to bone marrow aspiration and/or biopsy before and during treatment
- Women of childbearing potential must agree to use effective contraception during the study and for 30 days after
- Male patients with female partners of childbearing potential must agree to use condoms during the study and for 30 days after
You will not qualify if you...
- Previous treatment with menin inhibitors resulting in disease progression
- Active central nervous system leukemia (CNS involvement) at screening
- Serum total bilirubin above 1.5 times the upper normal limit, except for Gilbert's disease cases with specific criteria
- Elevated liver enzymes (ALT or AST) above specified limits depending on liver involvement
- Estimated glomerular filtration rate or creatinine clearance below 50 mL/min
- INR or aPTT above 1.5 times upper normal limit unless on anticoagulant therapy
- Known clinically significant liver disease or viral hepatitis without viral control
- Known HIV infection
- Pregnancy or breastfeeding
- Stroke or intracranial hemorrhage within 6 months prior to study drug
- Other primary cancers within 5 years except certain treated non-invasive tumors
- Certain cardiac conditions including abnormal heart rhythms and significant cardiovascular disease
- Recent systemic anti-tumor therapy or radiotherapy within 2 weeks before study treatment
- Hematopoietic stem cell transplant (HSCT) within 60 days before treatment or ongoing immunosuppressive therapy for graft versus host disease
- Use of herbal or traditional medicines with anti-tumor activity within 1 week before treatment
- Use of strong CYP3A4 inducers or inhibitors within 2 weeks or 5 half-lives before treatment
- Recent participation in other drug clinical trials with specific washout periods
- Major surgery within 4 weeks before first dose
- Unresolved toxicities from previous anti-tumor treatments above grade 1 (except alopecia)
- Active uncontrolled infection requiring hospitalization or intravenous antibiotics
- Conditions affecting oral drug absorption such as severe gastrointestinal diseases
- Poor compliance or other significant diseases or abnormalities that may affect safety or study results
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Xiangya Hospital of Central South University
Changsha, China
Actively Recruiting
2
First Affiliated Hospital of Chongqing Medical University
Chongqing, China
Actively Recruiting
3
Fujian Medical University Union Hospital
Fuzhou, China
Not Yet Recruiting
4
Nanfang Hospital, Southern Medical University
Guangzhou, China
Actively Recruiting
5
Sun Yat-sen University Cancer Center
Guangzhou, China
Not Yet Recruiting
6
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Not Yet Recruiting
7
The First Affiliated Hospital, Zhejiang University
Hangzhou, China
Actively Recruiting
8
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
9
Qilu Hospital of Shandong University
Jinan, China
Actively Recruiting
10
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Actively Recruiting
11
Shengjing Hospital of China Medical University
Shenyang, China
Actively Recruiting
12
The First Affiliated Hospital of Soochow University
Suzhou, China
Actively Recruiting
13
Blood Diseases Hospital, Chinese Academy of medical Sciences
Tianjin, China
Actively Recruiting
14
Tianjin People's Hospital
Tianjin, China
Actively Recruiting
15
Wuhan Union Hospital of China
Wuhan, China
Actively Recruiting
16
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
E
Erin Lou, Doctor
CONTACT
P
Panfeng Tan, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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