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IDH Inhibitor

HMPL-306 for Isocitrate Dehydrogenase Deficiency

Phase 1
Waitlist Available
Research Sponsored by Hutchison Medipharma Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists.
ECOG performance status 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pk weeks at screening through safety follow-up, assessed up to 36 months
Awards & highlights

Study Summary

This trial is testing a new drug for safety, how well it works, and side effects in people with IDH mutation and advanced cancer.

Who is the study for?
This trial is for adults over 18 with advanced solid tumors that have an IDH mutation and have worsened despite standard treatments. Participants must be in fairly good physical condition (ECOG status 0 or 1) and cannot be pregnant, breastfeeding, or have severe infections, certain heart conditions, life-threatening complications of leukemia, specific gastrointestinal or liver diseases, or inadequate organ function.Check my eligibility
What is being tested?
The study is testing HMPL-306's safety and effectiveness on patients with IDH-mutated advanced solid tumors. It's an open-label trial meaning everyone knows what treatment they're getting. Researchers will look at how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), and any signs of tumor shrinkage.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection due to lowered immunity from treatment-related blood disorders; organ inflammation; possible heart rhythm changes if QT interval prolongation occurs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has returned or worsened after standard treatment and cannot be cured.
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I am fully active or can carry out light work.
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My cancer has an IDH mutation confirmed by a lab test.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pk weeks at screening through safety follow-up, assessed up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pk weeks at screening through safety follow-up, 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)
Duration of response (DoR)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2 Dose Expansion CohortsExperimental Treatment1 Intervention
Patients from each cohort will be administered HMPL-306 orally QD at the recommended phase 2 dose
Group II: Part 1 Dose Escalation CohortsExperimental Treatment1 Intervention
Patients from each cohort will be administered HMPL-306 orally QD

Find a Location

Who is running the clinical trial?

Hutchison Medipharma LimitedLead Sponsor
100 Previous Clinical Trials
13,459 Total Patients Enrolled
HutchmedLead Sponsor
27 Previous Clinical Trials
5,256 Total Patients Enrolled
John KauhStudy DirectorHMPL

Media Library

Isocitrate Dehydrogenase Deficiency Research Study Groups: Part 1 Dose Escalation Cohorts, Part 2 Dose Expansion Cohorts
HMPL-306 (IDH Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04762602 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous locations in this city that are administering the trial?

"Currently, there are 7 operational sites for this medical trial. Houston, Atlanta and Lexington host one of these locations while the other 4 clinics can be found in additional cities. To reduce travelling demands if you choose to participate, it is best that you select a clinic near your location."

Answered by AI

What is the ultimate goal of this medical experiment?

"This trial will evaluate the Number of Subjects with Dose Limiting Toxicities (DLTs) over a 37 day period. Secondary objectives include evaluation of Progression-free Survival (PFS), Maximum serum drug concentration, and Objective Response Rate (ORR). PFS is defined as time from first dose date of study drug to date of progression or death, while ORR is determined by assessing Complete Response or Partial Response rates."

Answered by AI

Are there any open spots available for enrolment in this investigation?

"Affirmative. According to the clinicaltrials.gov database, this research project is actively looking for 90 participants from 7 sites. First posted on February 28th 2021, it has been updated most recently in February 22nd 2022."

Answered by AI

What is the maximum participant limit for this experiment?

"Indeed, the information posted to clinicaltrials.gov indicates that this trial is currently enrolling participants. Initially listed on February 28th 2021, it has since been updated as of Feburary 22nd 2022 and requires 90 volunteers across 7 facilities."

Answered by AI

Has HMPL-306 received governmental authorization for commercialization?

"HMPL-306 has limited clinical data to demonstrate its safety and efficacy, therefore our team assigned it a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
2021. "A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04762602.
~22 spots leftby Apr 2025
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