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IDH Inhibitor

HMPL-306 for Isocitrate Dehydrogenase Deficiency

Phase 1
Recruiting
Research Sponsored by Hutchmed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects aged ≥18 years
ECOG performance status ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Awards & highlights

Study Summary

This trial is testing a new drug, HMPL-306, for people with cancer that has come back or does not respond to treatment.

Who is the study for?
This trial is for adults over 18 with advanced blood cancers that have come back or haven't responded to treatment, and who are not too sick to participate (ECOG ≤ 2). They mustn't be pregnant/breastfeeding, have severe infections, certain heart conditions, uncontrolled cancer complications, specific liver/gastrointestinal diseases, or poor organ function. Those allergic to HMPL-306 or its ingredients can't join.Check my eligibility
What is being tested?
The study tests HMPL-306's safety and effectiveness in patients with blood cancers containing IDH mutations. It's an open-label trial where all participants receive the drug; researchers will monitor how the body processes it and any signs of cancer improvement.See study design
What are the potential side effects?
While specific side effects of HMPL-306 aren't listed here, common ones for cancer drugs may include nausea, fatigue, risk of infection due to low blood cell counts, liver issues and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st dose of study drug to the time of progressive disease, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 1st dose of study drug to the time of progressive disease, assessed up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 and Part 2: Frequency and severity of AEs
Part 1: Number of Subjects with Dose Limiting Toxicities (DLTs)
Secondary outcome measures
Area under the concentration-time curve (AUC)
Clinical Benefit Rate (CBR)
Bone Marrow
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All patients will be administered HMPL-306 orally QD

Find a Location

Who is running the clinical trial?

HutchmedLead Sponsor
30 Previous Clinical Trials
5,721 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
101 Previous Clinical Trials
13,524 Total Patients Enrolled
Marjo Hahka-Kemppinen, MD, PhDStudy DirectorHutchison Medipharma Limited

Media Library

HMPL-306 (IDH Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04764474 — Phase 1
Isocitrate Dehydrogenase Deficiency Research Study Groups: Treatment
Isocitrate Dehydrogenase Deficiency Clinical Trial 2023: HMPL-306 Highlights & Side Effects. Trial Name: NCT04764474 — Phase 1
HMPL-306 (IDH Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04764474 — Phase 1
~5 spots leftby Sep 2024
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