A Study of HMPL-306 in Patients With IDH1 and/or IDH2 Mutation of Relapsed/Refractory Myeloid Leukemia/Neoplasms
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ClinicalTrials.gov Identifier: NCT04272957 |
Recruitment Status : Unknown
Verified June 2020 by Hutchmed ( Hutchison Medipharma Limited ).
Recruitment status was: Recruiting
First Posted : February 17, 2020
Last Update Posted : June 16, 2020
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Condition or disease | Intervention/treatment | Phase |
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Acute Myeloid Leukemia | Drug: HMPL-306 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 75 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | May 14, 2020 |
Estimated Primary Completion Date : | June 30, 2021 |
Estimated Study Completion Date : | December 30, 2022 |

Arm | Intervention/treatment |
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Experimental: HMPL-306
HMPL-306 administered continuously as a single agent orally every day in a 28-day cycle.
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Drug: HMPL-306
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. |
- Safety and tolerability: Incidence of adverse events [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]Incidence of adverse events.
- Maximum tolerated dosage (MTD) and/or recommended phase 2 dosage (RP2D) [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]Measured by adverse event profile.
- Cmax (Cycle 1 Day 1) of HMPL-306 [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start ]Cmax: maximum observed drug concentration in measured matrix after single dose administration.
- AUC(0-24) (Cycle 1 Day 1) of HMPL-306 [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start ]AUC: area under the concentration vs. time curve from zero to infinity after single (first) dose.
- AUC(0-tlast) (Cycle 1 Day 1) of HMPL-306 [ Time Frame: Pre-dose, 10 minutes, 1, 1.5, 2, 3, 5, 8, 11, 24, 48, 72, 120 and 168 hours after start ]AUC from time zero to the last data point.
- Objective Response Rate (ORR) [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]proportion of patients with confirmed complete response (CR) and partial response (PR).
- Duration of response (DOR) [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]DOR is defined as the time from the date of first observed tumor response (Complete response (CR) or Partial response (PR)) until first subsequent disease progression or until death (if death occurs before progression is documented) due to any cause.
- Progression-free survival (PFS) [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]PFS is defined as the time from enrollment (i.e., date of treatment assignment) to disease progression.
- Overall survival (OS) [ Time Frame: Baseline up to the last patient has completed the 24 weeks of treatment ]OS is defined as the time from enrollment (i.e., date of treatment assignment) until death from any cause or until the last date the patient is known to be alive.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ≥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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272957
Contact: Xianlin Duan | 02120678852 | xianlind@hmplglobal.com | |
Contact: Lang Zhang | 02120673224 | langz@hmplglobal.com |
China, Beijing | |
Peking University People's Hospital | Recruiting |
Beijing, Beijing, China | |
Contact: Xiaojun Huang, Professor huangxiaojun@bjmu.edu.cn |
Study Director: | Weiss Yang | Hutchison MediPharma Ltd |
Responsible Party: | Hutchison Medipharma Limited |
ClinicalTrials.gov Identifier: | NCT04272957 |
Other Study ID Numbers: |
2018-306-00CH1 |
First Posted: | February 17, 2020 Key Record Dates |
Last Update Posted: | June 16, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HMPL-306 IDH1 Mutation IDH2 Mutation Acute myeloid leukemia |
Myelodysplastic symdrome Chronic myelomonocytic leukemia Myeloid Leukemia/Neoplasms |
Leukemia Neoplasms Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms by Histologic Type |