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New treatment option for Hematological Malignancies
Official title A Clinical Study of HMPL-506 in Patients With Hematological Malignancies
ClinicalTrials.gov ID: NCT06387082
What this study is testing
What is HMPL-506?
HMPL-506 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hematological malignancies.
Also referred to as Two strengths of HMPL-506 tablets (25 mg and 100 mg) will be used for this clinical study.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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...
- MLL-rearranged and/or NPM1-mutant relapsed/refractory AML
You likely can't join if
- people 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...
- 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...
See the full eligibility criteria
Who can join
- people 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)...
- 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...
- 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...
What rules you out
- people 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...
- 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...
- 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)...
- 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...
- 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.
- Use of potent inducers or inhibitors of CYP3A4 within 2 weeks (3 weeks for St John's wort) or 5 half-lives (whichever is longer) before initiation of study treatment.
- An interval of less than 2 weeks from the last dose of any small molecular drug or of less than 4 weeks from the last dose of any macromolecular drug (e.g., antibody drugs) administered during previous participation in...
- Patients who have undergone major surgery within 4 weeks prior to the first dose of the investigational product.
- Toxicities from previous anti-tumor treatments have not yet recovered to Grade ≤ 1 (excluding alopecia).
- Patients with uncontrolled active infection requiring hospitalization or intravenous antibiotics (defined as persistent signs/symptoms related to the infection without improvement despite receipt of appropriate...
- Patients with neutropenia who, in the opinion of the investigator, require prophylactic intravenous antibiotics can be enrolled
- Presence of conditions that may affect the absorption of the investigational product as judged by the investigator, such as inability to take drugs orally, past surgery history or severe gastrointestinal diseases...
- Patients with poor compliance who are judged by the investigator as not suitable for participation in this clinical study.
- Any other disease, metabolic abnormality, physical examination abnormality or clinically significant laboratory test abnormality, based on which the investigator has reason to suspect that the patient has certain...
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, China
- Chongqing, China
- Fuzhou, China
- Guangzhou, China
- Guiyang, China
- Hangzhou, China
- Hefei, China
- Jinan, China
- Nanjing, China
- Shenyang, China
- Suzhou, China
- Tianjin, China
- Wuhan, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, China; Chongqing, China; Fuzhou, China; Guangzhou, China; Guiyang, China; Hangzhou, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.