A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH (NCT04764474) | Clinical Trial Compass
TerminatedPhase 1
A Study of HMPL-306 in Advanced Hematological Malignancies With mIDH
Stopped: The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns
United States, Spain46 participantsStarted 2021-04-12
Plain-language summary
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in subjects with advanced relapsed, refractory, or resistant hematological malignancies that harbor IDH mutations.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Key Inclusion Criteria:
Subjects may be enrolled in this study only if they satisfy all the following criteria (NOTE: This is not an exhaustive list):
* Subjects aged ≥18 years.
* ECOG performance status ≤ 2
* Subjects with advanced relapsed, refractory, or resistant hematological malignancies, as defined below:
Part 1:
* Subjects with documented IDH mutation per local or institutional next generation sequence (NGS).
* Subjects must be refractory to or intolerant of established therapies.
* Subjects who have received prior IDH inhibitor treatment may be enrolled in the escalation phase.
Part 2:
* Subjects with documented IDH mutation of any of these subsets: IDH1 (R132C), IDH1 (R132H), IDH (R140Q), and IDH2 (R172K), including co-mutations and any combination thereof per local and institutional NGS.
* Patients must have received at least 1 prior line of therapy with an IDH inhibitor. An established standard of care with proven benefit for which the patient is eligible, must not be available at the time of enrollment.
* Patients with AML must not have standard therapeutic options available (including IDH inhibitors where approved) and have the following:
* i. Relapsed AML unsuitable for intensive chemotherapy or venetoclax-based regimen or target agents;
* ii. Primary refractory AML unsuitable for intensive chemotherapy or venetoclax-based regimen or target agents.
* iii. Relapsed/refractory AML that has progressed on prior IDH treatment
Key Exclusion Criteria:
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Escalation Part: Recommended Phase 2 Dose (RP2D) of HMPL-306
Timeframe: From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
2
Dose Escalation Part: Number of Patients With Dose-Limiting Toxicities (DLTs)
Timeframe: From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
3
Number of Patients With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events (TESAEs)
Timeframe: From the first dose of study drug (Day 1) up to 30 days after the last dose of study drug, approximately 25.25 months