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Kinase Inhibitor

RET Inhibitor for Solid Cancers ((MARGARET) Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Helsinn Healthcare SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Phase I Dose-Escalation - Specific inclusion criteria: Advanced solid tumors
Phase II: Available RET-gene abnormalities determined on tissue or liquid biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization until the date of death due to any cause, assessed up to an average of 2 years
Awards & highlights

(MARGARET) Trial Summary

This trial is testing a new drug, TAS0953/HM06, to see if it is safe and effective in treating patients with advanced solid tumors with RET gene abnormalities.

Who is the study for?
This trial is for adults with advanced solid tumors that have specific RET gene abnormalities. Participants should be in good physical condition (ECOG score of 0-1 or 2), have adequate organ function, and no major recent surgeries. They must not have certain genetic mutations like EGFR or KRAS, uncontrolled heart issues, or a history of severe heart rhythm problems.Check my eligibility
What is being tested?
The study tests TAS0953/HM06's safety and effectiveness on patients with RET-related tumors. Phase 1 determines the safest high dose to use; Phase 2 uses this dose to further evaluate treatment effects.See study design
What are the potential side effects?
While the side effects for TAS0953/HM06 are not detailed here, similar drugs often cause tiredness, nausea, changes in blood pressure or heartbeat, liver issues, and potential allergic reactions.

(MARGARET) Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have an advanced solid tumor.
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My tests show RET-gene abnormalities.
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I have brain metastases but haven't had symptoms, and I haven't taken steroids or anticonvulsants for at least a week.
Select...
Criterion: You have non-small cell lung cancer with a specific genetic change called a RET gene fusion. You may also be eligible if you have a different type of advanced cancer with the same genetic change and have already tried other treatments. You should be in good overall health and have certain blood, liver, and kidney function. If you have brain or spinal cord tumors, they should not be causing symptoms or should be stable after treatment.
Select...
I have advanced lung cancer with a RET gene mutation and have been treated with RET inhibitors.
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My blood, liver, and kidney functions are all within normal ranges.
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My condition worsened after treatment or I can't receive standard treatments.
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I am fully active or have some restrictions but can still care for myself.
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My cancer has RET gene changes found in a biopsy.
Select...
I have brain metastases but do not have any symptoms.

(MARGARET) Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization until the date of death due to any cause, assessed up to an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until the date of death due to any cause, assessed up to an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Phase 2: Objective Response Rate (ORR) by independent data monitoring committee (IDMC)
Secondary outcome measures
Phase 1 (dose expansion): Objective Response Rate (ORR) by IDMC
Phase 1 (dose-escalation): AUC0-12 at steady state
Phase 1 (dose-escalation): AUC0-24
+38 more

(MARGARET) Trial Design

2Treatment groups
Experimental Treatment
Group I: TAS0953/HM06 Phase 2Experimental Treatment1 Intervention
Treatment phase at recommended Phase 2 dose in three different populations
Group II: TAS0953/HM06 Phase 1Experimental Treatment1 Intervention
Dose escalation and dose expansion until recommended Phase 2 dose determined

Find a Location

Who is running the clinical trial?

Helsinn Healthcare SALead Sponsor
41 Previous Clinical Trials
9,373 Total Patients Enrolled
ICON Clinical ResearchIndustry Sponsor
49 Previous Clinical Trials
15,170 Total Patients Enrolled

Media Library

TAS0953/HM06 (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04683250 — Phase 1 & 2
Solid Tumors Research Study Groups: TAS0953/HM06 Phase 2, TAS0953/HM06 Phase 1
Solid Tumors Clinical Trial 2023: TAS0953/HM06 Highlights & Side Effects. Trial Name: NCT04683250 — Phase 1 & 2
TAS0953/HM06 (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04683250 — Phase 1 & 2

Frequently Asked Questions

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

Are there any available vacancies for this clinical trial?

"That is correct, the online clinicaltrials.gov registry currently lists this trial as recruiting patients. This study was originally posted on December 16th 2020 and last updated on April 13rd 2022. At present, there are 9 different enrolment sites looking for a total of 202 participants."

Answered by AI

Please give me the total number of participating facilities for this research project.

"Nine clinical trial sites are currently operational for this study, which include START Midwest - Cancer & Hematology Centers of Western Michigan in Grand Rapids, The Sarah Cannon Research Institute/Tennessee Oncology in Nashville, Chao Family Comprehensive Cancer Center in Orange, and 6 additional locations."

Answered by AI

How many people are participating in this experiment?

"Yes, the information available on clinicaltrials.gov attests to this trial's activeness in recruiting patients. This study was first posted on December 16th 2020 and received its latest update on April 13th 2022. The 9 different enrolment locations are looking for a total of 202 participants."

Answered by AI
~44 spots leftby Mar 2025