A Phase 1/2 interventional study of TAS0953/HM06 and TAS0953/HM06 in RET-altered Non Small Cell Lung Cancer and RET-altered Solid Tumors, sponsored by Taiho Pharmaceutical Co., Ltd.. Recruiting at 29 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Taiho Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 1/2, Interventional, and Treatment
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.
7,620 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,838 are open to participants now.
This study's planned enrollment of 244 is above the median of 62 across 6,019 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Taiho Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ages Eligible for Study:
- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)
Inclusion Criteria:
Phase I - Common inclusion criteria for Dose-Escalation / Dose-Expansion:
Phase I Dose-Escalation - Specific inclusion criteria:
Phase I Dose-Expansion - Specific inclusion criteria:
Patient with RET gene fusion :
If patient has brain and/or leptomeningeal metastases,(s)he should have:
Phase II :
Locally advanced or metastatic:
If patient has brain and/or leptomeningeal metastases,(s)he should have:
Exclusion Criteria:
Common exclusion criteria for Phase 1 and Phase 2
Phase I Dose-Expansion - and Phase II specific exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose escalation and dose expansion until recommended Phase 2 dose determined
Drug: TAS0953/HM06
Treatment phase at recommended Phase 2 dose in three different populations
Drug: TAS0953/HM06
Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)
Incidence rate and category of dose limiting toxicities (DLTs)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
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
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed 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 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
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
Proportion of patients with confirmed complete response (CR) and or partial response (PR) according to RECIST 1.1 as assessed 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)
Proportion of patients with confirmed complete response (CR), partial response (PR) and Stable Disease according to RECIST 1.1 as assessed 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: Time to Tumor Response (TTR)
Time from first dose to first documentation of objective tumor response (CR or PR)
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 from first dose to first documentation of objective disease progression or to death due to any cause, whichever occurs first
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 from first dose to objective tumor progression
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 from first documentation of tumor response (CR + PR) to disease progression or death due any cause whichever occurs first
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 from first dose to date of death due to any cause
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)
Rate of confirmed CR and PR relative to patients with brain lesions at study entry
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 from documentation of intracranial tumor response to disease progression or death due to any cause whichever occurs first
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 from the first dose to the first radiological evidence of CNS disease 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)
Phase 2: Incidence of serious adverse events (SAEs)
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)
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Plan to share: Undecided
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Started Dec 2020 (actual). Primary completion is estimated for Mar 2030, 111 months after the start.
Of 308 industry-sponsored phase 1/2 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 77. This study's planned 111 months is above that.
Counting every sponsor, half of 431 studies reached it within 63 months; a quarter within 42 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Carcinoma, Non-Small-Cell Lung →
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