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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 belowSelect...
I am 18 years old or older.
Select...
I can take care of myself but might not be able to do heavy physical work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 1st dose of study drug to the time of progressive disease, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 1st dose of study drug to the time of progressive disease, assessed up to 36 months
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 moreTrial 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
27 Previous Clinical Trials
5,271 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
13,474 Total Patients Enrolled
Marjo Hahka-Kemppinen, MD, PhDStudy DirectorHutchison Medipharma Limited
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any new cancers in the last 2 years, except for certain skin cancers or early-stage cervical or breast cancer.I am 18 years old or older.My blood cancer has come back or hasn't responded to treatment.I do not have a severe infection or unexplained fever over 38.3°C.I am not on medications that affect my heart's rhythm.I am experiencing severe complications from leukemia, like uncontrolled bleeding or serious infections.I have or had liver or gastrointestinal diseases.I have a history of heart conditions.I can take care of myself but might not be able to do heavy physical work.My organs are not working well enough for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is HMPL-306 considered to be a safe option for humans?
"Due to the preliminary nature of HMPL-306 research, Power assesses its safety on a scale from 1 to 3 with a score of 1. This implies that there is scant evidence supporting both efficacy and safety."
Answered by AI
How many health centers are conducting this experiment?
"Currently, this medical study is taking place at six different locations. This includes Froedtert-Medical College of WI in Milwaukee, Emory University in Atlanta, and The University of Texas MD Anderson Cancer Center in Houston as well as three other sites."
Answered by AI
Are there still vacant slots in this clinical trial?
"Affirmative. The details on clinicaltrials.gov confirm that this study is currently recruiting participants, with the first post published on February 28th 2021 and last updated November 2nd 2022. 75 patients are needed from 6 different medical centres."
Answered by AI
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