Study of TAS0953/HM06 for RET-altered Advanced Solid Tumors
This study is testing a drug called TAS0953/HM06 for people with advanced solid tumors, including a type of lung cancer, that have specific changes in a gene called RET. The study has two parts. The first part aims to find the safest and most effective dose of TAS0953/HM06. The second part will then use that dose to see how well the drug shrinks tumors. To join, you must be an adult with an ECOG performance score of 0 or 1, and your tumor must show these RET gene changes, which can be found through a tissue or liquid biopsy. The study is looking to enroll 244 participants.
- Study design
- This is an interventional study with no specified phase, but it includes both Phase 1 and Phase 2 components. It plans to enroll 244 participants.
- What's involved
- You would take TAS0953/HM06 orally twice a day in 21-day cycles. Tumor responses will be checked approximately every 6 weeks for 6 months, then every 9 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- If your disease does not progress, you will be followed for approximately 10 months in Phase 1, and for up to an average of 2 years after your last dose in Phase 2.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04683250
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Recruiting
PHASE1Ages 18+InterventionalTreatmentTaiho Pharmaceutical Co., Ltd.
~244 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:TAS0953/HM06
At a glance
Recruiting sites
20 of 29 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Measured over At the end of Cycle 1 (each cycle is 21 days)
+2 more outcomes measured
Conditions
Where it's being run
29 sites across 15 statesJapan5
South Korea4
Australia3
California2
Michigan2
New York2
Osaka2
Tokyo2
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
Available RET-gene abnormalities determined on tissue biopsy or liquid biopsy. If deemed appropriate by the investigator, determination on a pleural cell block or cell pellet is also acceptable.
Adequate hematopoietic, hepatic and renal function
Advanced solid tumors
Measurable and/or non-measurable disease as determined by RECIST 1.1
If patient has brain and/or leptomeningeal metastases, (s)he should be asymptomatic.
Patient with RET gene fusion :
Cohort 1, 3: locally advanced or metastatic NSCLC patients naïve to RET selective inhibitors and no prior systemic anti-cancer treatment. Patients who have been treated with neo-adjuvant or adjuvant chemotherapy may be included if it has been completed at least 6 months prior to the first dose of the study.
Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.
Measurable disease as determined by RECIST 1.1
If patient has brain and/or leptomeningeal metastases,(s)he should have:
asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
Available RET-gene abnormalities determined on tissue or liquid biopsy
Locally advanced or metastatic:
NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;
NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors
patients with advanced solid tumors that harbour RET gene abnormalities (other than NSCLC patients with primary RET gene fusions) and has failed all the available therapeutic options
Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
Measurable disease as determined by RECIST 1.1
If patient has brain and/or leptomeningeal metastases,(s)he should have:
asymptomatic untreated brain/leptomeningeal metastases off steroids and anticonvulsant for at least 7 days or
asymptomatic brain metastases already treated with local therapy and be clinically stable on steroids and anticonvulsant for at least 7 days before study drug administration.
Adequate hematopoietic, hepatic and renal function
Exclusion
Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug
Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug or planned major surgery during the course of study treatment.
Whole Brain Radiotherapy within 14 days or other palliative radiotherapy within 7 days prior to the first dose of study drug, or persisting side effects of such therapy, in the opinion of the Investigator.
Clinically significant, uncontrolled, cardiovascular disease including myocardial infarction within 3 months prior to Day 1 of Cycle 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension, according to the Investigator's opinion.
QT interval corrected using Fridericia's formula (QTcF) \>470 msec; personal or family history of prolonged QT syndrome or history of Torsades de pointes (TdP). History of risk factors for TdP
Treatment with strong CYP3A4 inhibitors within 1 week prior to the first dose of study drug or strong CYP3A4 inducers within 3 weeks prior to the first dose of study drug.
Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
What this trial measures
- Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)At the end of Cycle 1 (each cycle is 21 days)
Incidence rate and category of dose limiting toxicities (DLTs)
- Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)At the end of Cycle 1 (each cycle is 21 days), and at the end of every subsequent cycle (each cycle is 21 days) for approximately 10 months (or earlier if patient discontinues the study)
- Phase 2: Objective Response Rate (ORR) by independent central reviewApproximately every 6 weeks for 6 months, then every 9 weeks during treatment, 7 days after the last dose, and every 3 months after the last dose (up to an average of 2 years) in patients without progressive disease.
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by independent central review