RET-altered Non Small Cell Lung CancerPhase 1/2MARGARETNCT04683250
Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
A Phase 1/2 study testing TAS0953/HM06 in people with RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, run by Taiho Pharmaceutical Co., Ltd. at 29 sites in 4 countries.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RET-altered Non Small Cell Lung Cancer, RET-altered Solid Tumors
- What is being tested?
- TAS0953/HM06
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 29 sitesin 4 countries
- Study dates
- 16 Dec 2020to Mar 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 28Show fewer
- 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
Who cannot join
- Common exclusion criteria for Phase 1 and Phase 2
- 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
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- 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:
- Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.
Trial locations and contacts
29 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 4 countries
Japan13 sites, 13 recruiting
- Recruiting
Aichi Cancer Center
Aichi
- Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
- Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka
- Recruiting
Kansai Medical University Hospital
Hirakata-shi, Osaka
- Recruiting
Kanagawa Cancer Center
Kanagawa
- Recruiting
National Cancer Center Hospital East
Kashiwa-shi, Chiba
- Recruiting
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
- Recruiting
Okayama University Hospital
Okayama, Okayama-ken
- Recruiting
Kurashiki Central Hospital
Okayama
- Recruiting
Osaka International Cancer Institute
Osaka, Osaka
- Recruiting
Kindai University Hospital
Osaka
- Recruiting
Tohoku University Hospital
Sendai, Miyagi
- Recruiting
Shizuoka Cancer Center
Shizuoka, Shizuoka
United States9 sites
- Terminated
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Terminated
Henry Ford Hospital
Detroit, Michigan, 48202
- Terminated
START Midwest - Cancer & Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
- Terminated
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030-4009
- Terminated
The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee, 37203
- Terminated
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
- Terminated
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Terminated
Chao Family Comprehensive Cancer Center
Orange, California, 92868-3298
- Terminated
Stanford Cancer Center
Stanford, California, 94305-5826
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
- Recruiting
Severance Hospital
Seoul
Australia3 sites, 3 recruiting
- Recruiting
Cabrini Hospital
Malvern
- Recruiting
Linear Clinical Research
Nedlands
- Recruiting
GenesisCare North Shore
Saint Leonards
About this study
Official title: 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.
- Being tested
- TAS0953/HM06
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS0953/HM06Drug
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
TAS0953/HM06Drug
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
| Study group | Role | What they receive |
|---|---|---|
| TAS0953/HM06 Phase 1 | Experimental | Dose escalation and dose expansion until recommended Phase 2 dose determined Receives: Drug: TAS0953/HM06 |
| TAS0953/HM06 Phase 2 | Experimental | Treatment phase at recommended Phase 2 dose in three different populations Receives: Drug: TAS0953/HM06 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Incidence rate and category of dose limiting toxicities (DLTs)
Measured: At the end of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)
Measured: 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 review
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by independent central review
Measured: Approximately 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.
Secondary outcomes (41)
Phase 1 (dose expansion): Objective Response Rate (ORR) by independent central review
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by independent central review
Measured: Approximately 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
Phase 2: ORR by Investigator
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed by Investigator
Measured: Approximately 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
Phase 2: Disease Control Rate (DCR)
Proportion of patients with confirmed complete response (CR), partial response (PR) and Stable Disease according to RECIST 1.1 as assessed by Investigator
Measured: Approximately 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
Phase 2: Time to Tumor Response (TTR)
Time from first dose to first documentation of objective tumor response (CR or PR)
Measured: From date of randomization until the date of first documentation of objective tumor response, assessed up to an average of 2 years.
Phase 2: Progression Free Survival (PFS)
Time from first dose to first documentation of objective disease progression or to death due to any cause, whichever occurs first
Measured: From date of randomization until the date of first documented progression or death due to any cause, whichever occurs first, assessed up to an average of 2 years.
Phase 2: Time to Progression (TTP)
Time from first dose to objective tumor progression
Measured: From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Phase 2: Duration of Response (DOR)
Time from first documentation of tumor response (CR + PR) to disease progression or death due any cause whichever occurs first
Measured: From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Phase 2: Overall Survival (OS)
Time from first dose to date of death due to any cause
Measured: From date of randomization until the date of death due to any cause, assessed up to an average of 2 years
Phase 2: Central Nervous System (CNS) ORR (C-ORR)
Rate of confirmed CR and PR relative to patients with brain lesions at study entry
Measured: Approximately 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
Phase 2: Central Nervous System DOR (C-DOR)
Time from documentation of intracranial tumor response to disease progression or death due to any cause whichever occurs first
Measured: From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Phase 2: Time to CNS progression
Time from the first dose to the first radiological evidence of CNS disease progression
Measured: From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Phase 1 (dose-escalation): Area under the plasma concentration versus time curve from time 0 to 12 hours (AUC0-12)
Measured: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-24
Measured: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-infinity
Measured: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-12 at steady state
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Maximum drug concentration (Cmax)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Trough drug concentration at 12 hours (Ctrough)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Time to maximum plasma concentration (tmax)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Terminal half-life (t1/2)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Accumulation factor based on Cmax (Rmax)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Accumulation factor based on Ctrough (Rmin)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Terminal rate constant (lambda_z)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Volume of Distribution (Vz/F)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Systemic clearance (CL/F)
Measured: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Amount excreted in 0-24 hour urine (Ae0-24)
Measured: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Renal Clearance (CL_R)
Measured: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): AUC0-12 at steady state
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Maximum drug concentration (Cmax)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Trough drug concentration at 12 hours (Ctrough)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Time to maximum plasma concentration (tmax)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Terminal rate constant (lambda_z)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Terminal half-life (t1/2)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of absorption rate constant (Ka)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of CL/F
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of volume of distribution (V/F)
Measured: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Measured: On Day 1, Day 8 (only in dose escalation), Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 10 months (or earlier if the patient discontinues from the study), and 7 days after last dose
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Measured: From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Phase 1: Incidence of serious adverse events (SAEs)
Measured: From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Phase 2: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Measured: On Day 1 and Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 2 years (or earlier if the patient discontinues from the study), and 7 days after last dose
Phase 2: Incidence of treatment-emergent adverse events (TEAEs)
Measured: From the time of informed consent for approximately 2 years (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Phase 2: Incidence of serious adverse events (SAEs)
Measured: From the time of informed consent for approximately 2 years (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start16 Dec 2020
- Primary completionMar 2030 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RET-altered Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Dose escalation phase followed by a dose expansion phase (Phase 1), then followed by a Phase 2 at the recommended dose
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683250
- Sponsor's protocol ID
- HM06-19-26
- Acronym
- MARGARET
- Status last verified
- Feb 2026
- First submitted
- 4 Dec 2020
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of the Selective RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities
- ClinicalTrials.gov ID
- NCT04683250
- Acronym / sponsor ID
- MARGARET / HM06-19-26
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 24 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dose escalation phase followed by a dose expansion phase (Phase 1), then followed by a Phase 2 at the recommended dose
| Arm | Type | Receives |
|---|---|---|
| TAS0953/HM06 Phase 1 | Experimental | Drug: TAS0953/HM06Dose escalation and dose expansion until recommended Phase 2 dose determined |
| TAS0953/HM06 Phase 2 | Experimental | Drug: TAS0953/HM06Treatment phase at recommended Phase 2 dose in three different populations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- 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
Key exclusion criteria (9 listed)
- Common exclusion criteria for Phase 1 and Phase 2
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS0953/HM06Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days | Drug | TAS0953/HM06 Phase 1 |
| TAS0953/HM06Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days | Drug | TAS0953/HM06 Phase 2 |
Primary outcome
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Time frame: 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)
Time frame: 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 review
Time frame: Approximately 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
41 secondary outcomes
Phase 1 (dose expansion): Objective Response Rate (ORR) by independent central review
Time frame: Approximately 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
Phase 2: ORR by Investigator
Time frame: Approximately 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
Phase 2: Disease Control Rate (DCR)
Time frame: Approximately 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
Phase 2: Time to Tumor Response (TTR)
Time frame: From date of randomization until the date of first documentation of objective tumor response, assessed up to an average of 2 years.
Phase 2: Progression Free Survival (PFS)
Time frame: From date of randomization until the date of first documented progression or death due to any cause, whichever occurs first, assessed up to an average of 2 years.
Phase 2: Time to Progression (TTP)
Time frame: From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Phase 2: Duration of Response (DOR)
Time frame: From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Phase 2: Overall Survival (OS)
Time frame: From date of randomization until the date of death due to any cause, assessed up to an average of 2 years
Phase 2: Central Nervous System (CNS) ORR (C-ORR)
Time frame: Approximately 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
Phase 2: Central Nervous System DOR (C-DOR)
Time frame: From first documentation of objective tumor response (CR or PR) until the date of first documented progression or death due to any causes, whichever occurs first, assessed up to an average of 2 years
Phase 2: Time to CNS progression
Time frame: From date of randomization until the date of first documented progression, assessed up to an average of 2 years
Phase 1 (dose-escalation): Area under the plasma concentration versus time curve from time 0 to 12 hours (AUC0-12)
Time frame: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-24
Time frame: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-infinity
Time frame: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): AUC0-12 at steady state
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Maximum drug concentration (Cmax)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Trough drug concentration at 12 hours (Ctrough)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Time to maximum plasma concentration (tmax)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Terminal half-life (t1/2)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Accumulation factor based on Cmax (Rmax)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Accumulation factor based on Ctrough (Rmin)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Terminal rate constant (lambda_z)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Volume of Distribution (Vz/F)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Systemic clearance (CL/F)
Time frame: Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Amount excreted in 0-24 hour urine (Ae0-24)
Time frame: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-escalation): Renal Clearance (CL_R)
Time frame: Day -1 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): AUC0-12 at steady state
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Maximum drug concentration (Cmax)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Trough drug concentration at 12 hours (Ctrough)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Time to maximum plasma concentration (tmax)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Terminal rate constant (lambda_z)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1 (dose-expansion): Terminal half-life (t1/2)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of absorption rate constant (Ka)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of CL/F
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 2 Population PK: Typical value of volume of distribution (V/F)
Time frame: Day 15 of Cycle 1 (each cycle is 21 days)
Phase 1: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Time frame: On Day 1, Day 8 (only in dose escalation), Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 10 months (or earlier if the patient discontinues from the study), and 7 days after last dose
Phase 1: Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Phase 1: Incidence of serious adverse events (SAEs)
Time frame: From the time of informed consent, for approximately 10 months (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Phase 2: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).
Time frame: On Day 1 and Day 15 in cycle 1, Day 1 of any subsequent cycles (each cycle is 21 days) during treatment, for approximately 2 years (or earlier if the patient discontinues from the study), and 7 days after last dose
Phase 2: Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From the time of informed consent for approximately 2 years (or earlier if the patient discontinues from the study), and through Safety Follow-up (28 days after the last dose)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAS0953/HM06 in people with RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, run by Taiho Pharmaceutical Co., Ltd. at 29 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Japan, United States, South Korea, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kazuo Koba (+81-3-3294-4527, k-koba@taiho.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD) (time frame: At the end of Cycle 1 (each cycle is 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.