Tests TAS0953/HM06 in adults with advanced solid tumors having RET gene changes
Tests the drug TAS0953/HM06 in adults with advanced cancers that have RET gene changes.
Plain-language title generated from the registry record
Registry title: Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Key facts
- Where
- Malvern, Nedlands, and Saint Leonards, AustraliaSee the 3 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced solid tumors, including lung cancer, that have a RET gene change. It tests the drug TAS0953/HM06.
- Age
- Adults (18 Years or older).
- Sex
- All sexes can join.
- Disease stage
- Advanced solid tumors. In later parts: locally advanced or metastatic non-small cell lung cancer (NSCLC) with a RET gene fusion, or other advanced solid tumors with RET gene changes where all available treatments have failed. Disease must be measurable by RECIST 1.1 in some parts.
- Earlier treatment
- Some groups must not have had a RET selective inhibitor or other cancer treatment before. Other groups must have had a RET selective inhibitor before.
- Biomarker or test result
- A RET gene change found on a tissue or liquid biopsy. Known EGFR, KRAS, ALK, HER2, ROS1, BRAF or METex14 activating mutations are not allowed in the expansion part and phase II.
Main reasons for not taking part
- Investigational drugs or cancer treatment within 5 half-lives before the first dose
- Major surgery within 4 weeks before the first dose
- Whole brain radiotherapy within 14 days or other palliative radiotherapy within 7 days before the first dose
- Uncontrolled heart disease, or QTcF over 470 msec or a history of prolonged QT syndrome
- Strong CYP3A4 inhibitors within 1 week or strong CYP3A4 inducers within 3 weeks before the first dose
Read by machine on 12 November 2026.
Where in Australia
- Cabrini HospitalMalvern, AustraliaContact: Kazuo KobaTaking people
- Linear Clinical ResearchNedlands, AustraliaContact: Kazuo KobaTaking people
- GenesisCare North ShoreSaint Leonards, AustraliaContact: Kazuo KobaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Taiho Pharmaceutical Co., Ltd.
- Trial code
- NCT04683250
- Record updated
- 19 August 2026
- Original description
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.Read full original descriptionShow less
Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953/HM06 in patients with advanced solid tumors with RET gene abnormalities. Phase 1 aims to determine the Maximum Tolerated Dose (MTD) and identify the Recommended Phase 2 Dose (RP2D) to be used in phase 2.
Inclusion: Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:; 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; Phase I Dose-Escalation - Specific inclusion criteria:; 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; Phase I Dose-Expansion - Specific inclusion criteria:; 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; Phase II :; 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; 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; Phase I Dose-Expansion - and Phase II specific exclusion criteria:; 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; Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations; Common exclusion criteria for Phase 1 and Phase 2.
Ages Eligible for Study:; Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region).