A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
A Phase I, Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics and Efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms With IDH1 and/or IDH2 Mutation
1 other identifier
interventional
75
1 country
1
Brief Summary
Phase I, multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics and efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms with IDH1 and/or IDH2 Mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedStudy Start
First participant enrolled
May 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedJune 16, 2020
June 1, 2020
1.1 years
February 13, 2020
June 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and tolerability: Incidence of adverse events
Incidence of adverse events.
Baseline up to the last patient has completed the 24 weeks of treatment
Maximum tolerated dosage (MTD) and/or recommended phase 2 dosage (RP2D)
Measured by adverse event profile.
Baseline up to the last patient has completed the 24 weeks of treatment
Secondary Outcomes (7)
Cmax (Cycle 1 Day 1) of HMPL-306
Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
AUC(0-24) (Cycle 1 Day 1) of HMPL-306
Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
AUC(0-tlast) (Cycle 1 Day 1) of HMPL-306
Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start
Objective Response Rate (ORR)
Baseline up to the last patient has completed the 24 weeks of treatment
Duration of response (DOR)
Baseline up to the last patient has completed the 24 weeks of treatment
- +2 more secondary outcomes
Study Arms (1)
HMPL-306
EXPERIMENTALHMPL-306 administered continuously as a single agent orally every day in a 28-day cycle.
Interventions
HMPL-306 administered continuously as a single agent starting at 25 mg orally every day in a 28-day cycle and dose escalation is planned up to 200mg. Subjects may continue treatment with HMPL-306 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.
Eligibility Criteria
You may qualify if:
- ≥18 years of age;
- Signed Informed Consent Form;
- Relapsed/refractory Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia(CMML) and others myeloid neoplasm;
- IDH1 and/or IDH2 mutated disease status as assessed by local laboratory;
- Cooperative Oncology Group (ECOG) performance status of 0-2;
- Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.
You may not qualify if:
- Previously treated with any prior IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy and had disease progression during treatment;
- with known involvement or clinical symptoms of central nervous system (CNS);
- Patients who have undergone HSCT within 60 days;
- Without adequate liver or kidney function;
- With known infection with active hepatitis B or C;
- With known infection with human immunodeficiency virus (HIV);
- History of clinically significant or active cardiac disease;
- Active clinically significant infection;
- Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors;
- Pregnancy or breast-feeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China
Related Publications (1)
Hu L, Wei X, Zhao W, Hu Y, Li J, Dong Y, Gong T, Zhang X, Xu Y, Zhang Y, Xu C, Zhang C, Cai Z, Jing H, Mi R, Wu W, He W, Wang H, Tang Q, Jiang Z, Liu H, Chen G, Sun J, Chen J, Yan S, Yan H, Wangwu J, Zhong Z, Wang L, Fan S, Shi M, Su W, Huang X. HMPL-306 in relapsed or refractory IDH1- and/or IDH2-mutated acute myeloid leukemia: A phase 1 study. Med. 2025 Jun 13;6(6):100575. doi: 10.1016/j.medj.2025.100575. Epub 2025 Jan 31.
PMID: 39892383DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Weiss Yang
Hutchison MediPharma Ltd
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
May 14, 2020
Primary Completion
June 30, 2021
Study Completion
December 30, 2022
Last Updated
June 16, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share