[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414948":3},{"organization":4,"outcomesModule":7,"designInfo":127,"detailedDescription":15,"studyPopulation":15,"armGroups":134,"interventions":145,"overallOfficials":15,"centralContacts":154,"locations":160,"responsibleParty":390,"collaborators":392,"id":395,"slug":15,"hasResults":396,"nctId":397,"briefTitle":398,"officialTitle":399,"acronym":400,"eligibilityCriteria":401,"healthyVolunteers":396,"sex":402,"minAge":403,"maxAge":15,"enrollmentInfo":404,"targetDuration":15,"studyType":407,"phases":408,"briefSummary":411,"conditions":412,"keywords":15,"overallStatus":250,"whyStopped":15,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":423,"locationsCount":424},{"fullName":5,"class":6},"Taiho Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":15},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"Phase 1 (dose-escalation): Maximum Tolerated Dose (MTD)","Incidence rate and category of dose limiting toxicities (DLTs)","At the end of Cycle 1 (each cycle is 21 days)",{"measure":14,"description":15,"timeFrame":16},"Phase 1 (dose-expansion): Recommended Phase 2 dose (RP2D)",null,"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)",{"measure":18,"description":19,"timeFrame":20},"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","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.",[22,25,28,31,35,39,43,47,51,54,57,60,63,65,67,70,73,75,77,79,81,83,85,87,89,91,93,95,97,99,101,103,105,107,109,111,114,117,119,122,125],{"measure":23,"description":19,"timeFrame":24},"Phase 1 (dose expansion): Objective Response Rate (ORR) by independent central review","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",{"measure":26,"description":27,"timeFrame":24},"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",{"measure":29,"description":30,"timeFrame":24},"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",{"measure":32,"description":33,"timeFrame":34},"Phase 2: Time to Tumor Response (TTR)","Time from first dose to first documentation of objective tumor response (CR or PR)","From date of randomization until the date of first documentation of objective tumor response, assessed up to an average of 2 years.",{"measure":36,"description":37,"timeFrame":38},"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","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.",{"measure":40,"description":41,"timeFrame":42},"Phase 2: Time to Progression (TTP)","Time from first dose to objective tumor progression","From date of randomization until the date of first documented progression, assessed up to an average of 2 years",{"measure":44,"description":45,"timeFrame":46},"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","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",{"measure":48,"description":49,"timeFrame":50},"Phase 2: Overall Survival (OS)","Time from first dose to date of death due to any cause","From date of randomization until the date of death due to any cause, assessed up to an average of 2 years",{"measure":52,"description":53,"timeFrame":24},"Phase 2: Central Nervous System (CNS) ORR (C-ORR)","Rate of confirmed CR and PR relative to patients with brain lesions at study entry",{"measure":55,"description":56,"timeFrame":46},"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",{"measure":58,"description":59,"timeFrame":42},"Phase 2: Time to CNS progression","Time from the first dose to the first radiological evidence of CNS disease progression",{"measure":61,"description":15,"timeFrame":62},"Phase 1 (dose-escalation): Area under the plasma concentration versus time curve from time 0 to 12 hours (AUC0-12)","Day -1 of Cycle 1 (each cycle is 21 days)",{"measure":64,"description":15,"timeFrame":62},"Phase 1 (dose-escalation): AUC0-24",{"measure":66,"description":15,"timeFrame":62},"Phase 1 (dose-escalation): AUC0-infinity",{"measure":68,"description":15,"timeFrame":69},"Phase 1 (dose-escalation): AUC0-12 at steady state","Day 15 of Cycle 1 (each cycle is 21 days)",{"measure":71,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Maximum drug concentration (Cmax)","Day -1 and Day 15 of Cycle 1 (each cycle is 21 days)",{"measure":74,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Trough drug concentration at 12 hours (Ctrough)",{"measure":76,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Time to maximum plasma concentration (tmax)",{"measure":78,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Terminal half-life (t1\u002F2)",{"measure":80,"description":15,"timeFrame":69},"Phase 1 (dose-escalation): Accumulation factor based on Cmax (Rmax)",{"measure":82,"description":15,"timeFrame":69},"Phase 1 (dose-escalation): Accumulation factor based on Ctrough (Rmin)",{"measure":84,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Terminal rate constant (lambda_z)",{"measure":86,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Volume of Distribution (Vz\u002FF)",{"measure":88,"description":15,"timeFrame":72},"Phase 1 (dose-escalation): Systemic clearance (CL\u002FF)",{"measure":90,"description":15,"timeFrame":62},"Phase 1 (dose-escalation): Amount excreted in 0-24 hour urine (Ae0-24)",{"measure":92,"description":15,"timeFrame":62},"Phase 1 (dose-escalation): Renal Clearance (CL_R)",{"measure":94,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): AUC0-12 at steady state",{"measure":96,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): Maximum drug concentration (Cmax)",{"measure":98,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): Trough drug concentration at 12 hours (Ctrough)",{"measure":100,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): Time to maximum plasma concentration (tmax)",{"measure":102,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): Terminal rate constant (lambda_z)",{"measure":104,"description":15,"timeFrame":69},"Phase 1 (dose-expansion): Terminal half-life (t1\u002F2)",{"measure":106,"description":15,"timeFrame":69},"Phase 2 Population PK: Typical value of absorption rate constant (Ka)",{"measure":108,"description":15,"timeFrame":69},"Phase 2 Population PK: Typical value of CL\u002FF",{"measure":110,"description":15,"timeFrame":69},"Phase 2 Population PK: Typical value of volume of distribution (V\u002FF)",{"measure":112,"description":15,"timeFrame":113},"Phase 1: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).","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",{"measure":115,"description":15,"timeFrame":116},"Phase 1: Incidence of treatment-emergent adverse events (TEAEs)","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)",{"measure":118,"description":15,"timeFrame":116},"Phase 1: Incidence of serious adverse events (SAEs)",{"measure":120,"description":15,"timeFrame":121},"Phase 2: Incidence of abnormal electrocardiograms (ECG QT interval). QT will be corrected for heart rate (QTc) using Fridericia's formula (QTcF).","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",{"measure":123,"description":15,"timeFrame":124},"Phase 2: Incidence of treatment-emergent adverse events (TEAEs)","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)",{"measure":126,"description":15,"timeFrame":124},"Phase 2: Incidence of serious adverse events (SAEs)",{"allocation":128,"interventionModel":129,"interventionModelDescription":130,"primaryPurpose":131,"observationalModel":15,"timePerspective":15,"maskingInfo":132},"NON_RANDOMIZED","SEQUENTIAL","Dose escalation phase followed by a dose expansion phase (Phase 1), then followed by a Phase 2 at the recommended dose","TREATMENT",{"masking":133,"maskingDescription":15,"whoMasked":15},"NONE",[135,141],{"label":136,"type":137,"description":138,"interventionNames":139},"TAS0953\u002FHM06 Phase 1","EXPERIMENTAL","Dose escalation and dose expansion until recommended Phase 2 dose determined",[140],"Drug: TAS0953\u002FHM06",{"label":142,"type":137,"description":143,"interventionNames":144},"TAS0953\u002FHM06 Phase 2","Treatment phase at recommended Phase 2 dose in three different populations",[140],[146,151],{"type":147,"name":148,"description":149,"armGroupLabels":150,"otherNames":15},"DRUG","TAS0953\u002FHM06","Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days",[136],{"type":147,"name":148,"description":152,"armGroupLabels":153,"otherNames":15},"Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days",[142],[155],{"name":156,"role":157,"phone":158,"phoneExt":15,"email":159},"Kazuo Koba","CONTACT","+08 8010113399","k-koba@taiho.co.jp",[161,175,184,194,204,213,222,228,238,248,260,274,288,297,309,322,332,341,353,366,376],{"facility":162,"status":163,"city":164,"state":165,"zip":166,"country":167,"countryCode":168,"cosmosGeoPoint":169,"geoPoint":174,"contacts":15},"Chao Family Comprehensive Cancer Center","TERMINATED","Orange","California","92868-3298","United States","US",{"type":170,"coordinates":171},"Point",[172,173],-117.85311,33.78779,{"lat":173,"lon":172},{"facility":176,"status":163,"city":177,"state":165,"zip":178,"country":167,"countryCode":168,"cosmosGeoPoint":179,"geoPoint":183,"contacts":15},"Stanford Cancer Center","Stanford","94305-5826",{"type":170,"coordinates":180},[181,182],-122.16608,37.42411,{"lat":182,"lon":181},{"facility":185,"status":163,"city":186,"state":187,"zip":188,"country":167,"countryCode":168,"cosmosGeoPoint":189,"geoPoint":193,"contacts":15},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":170,"coordinates":190},[191,192],-71.05977,42.35843,{"lat":192,"lon":191},{"facility":195,"status":163,"city":196,"state":197,"zip":198,"country":167,"countryCode":168,"cosmosGeoPoint":199,"geoPoint":203,"contacts":15},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":170,"coordinates":200},[201,202],-83.04575,42.33143,{"lat":202,"lon":201},{"facility":205,"status":163,"city":206,"state":197,"zip":207,"country":167,"countryCode":168,"cosmosGeoPoint":208,"geoPoint":212,"contacts":15},"START Midwest - Cancer & Hematology Centers of Western Michigan","Grand Rapids","49546",{"type":170,"coordinates":209},[210,211],-85.66809,42.96336,{"lat":211,"lon":210},{"facility":214,"status":163,"city":215,"state":215,"zip":216,"country":167,"countryCode":168,"cosmosGeoPoint":217,"geoPoint":221,"contacts":15},"Laura and Isaac Perlmutter Cancer Center at NYU Langone Health","New York","10016",{"type":170,"coordinates":218},[219,220],-74.00597,40.71427,{"lat":220,"lon":219},{"facility":223,"status":163,"city":215,"state":215,"zip":224,"country":167,"countryCode":168,"cosmosGeoPoint":225,"geoPoint":227,"contacts":15},"Memorial Sloan Kettering Cancer Center","10065",{"type":170,"coordinates":226},[219,220],{"lat":220,"lon":219},{"facility":229,"status":163,"city":230,"state":231,"zip":232,"country":167,"countryCode":168,"cosmosGeoPoint":233,"geoPoint":237,"contacts":15},"The Sarah Cannon Research Institute\u002FTennessee Oncology","Nashville","Tennessee","37203",{"type":170,"coordinates":234},[235,236],-86.78444,36.16589,{"lat":236,"lon":235},{"facility":239,"status":163,"city":240,"state":241,"zip":242,"country":167,"countryCode":168,"cosmosGeoPoint":243,"geoPoint":247,"contacts":15},"The University of Texas M. D. Anderson Cancer Center","Houston","Texas","77030-4009",{"type":170,"coordinates":244},[245,246],-95.36327,29.76328,{"lat":246,"lon":245},{"facility":249,"status":250,"city":251,"state":252,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":15,"geoPoint":15,"contacts":255},"National Cancer Center Hospital East","RECRUITING","Kashiwa-shi","Chiba","Japan","JP",[256],{"name":257,"role":157,"phone":258,"phoneExt":15,"email":259},"Kiyotaka Yoh, MD","+81-4-7133-1111","kyoh@east.ncc.go.jp",{"facility":261,"status":250,"city":262,"state":263,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":264,"geoPoint":268,"contacts":269},"Tohoku University Hospital","Sendai","Miyagi",{"type":170,"coordinates":265},[266,267],140.86667,38.26667,{"lat":267,"lon":266},[270],{"name":271,"role":157,"phone":272,"phoneExt":15,"email":273},"Eisaku Miyauchi, MD","+81-22-717-8539","eisaku.miyauchi.b5@tohoku.ac.jp",{"facility":275,"status":250,"city":276,"state":277,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":278,"geoPoint":282,"contacts":283},"Okayama University Hospital","Okayama","Okayama-ken",{"type":170,"coordinates":279},[280,281],133.93333,34.65,{"lat":281,"lon":280},[284],{"name":285,"role":157,"phone":286,"phoneExt":15,"email":287},"Kadoaki Ohashi, MD","+81-86-223-7151","pbto124g@s.okayama-u.ac.jp",{"facility":289,"status":250,"city":290,"state":291,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":15,"geoPoint":15,"contacts":292},"Kansai Medical University Hospital","Hirakata-shi","Osaka",[293],{"name":294,"role":157,"phone":295,"phoneExt":15,"email":296},"Takayasu Kurata, MD","+81-72-804-0101","uratat@hirakata.kmu.ac.jp",{"facility":298,"status":250,"city":291,"state":291,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"Osaka International Cancer Institute",{"type":170,"coordinates":300},[301,302],135.50107,34.69379,{"lat":302,"lon":301},[305],{"name":306,"role":157,"phone":307,"phoneExt":15,"email":308},"Kazumi Nishino, MD","+81-6-6945-1181","kazumi.nishino@oici.jp",{"facility":310,"status":250,"city":311,"state":311,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":312,"geoPoint":316,"contacts":317},"Shizuoka Cancer Center","Shizuoka",{"type":170,"coordinates":313},[314,315],138.38333,34.98333,{"lat":315,"lon":314},[318],{"name":319,"role":157,"phone":320,"phoneExt":15,"email":321},"Akira Ono, MD","+81-55-989-5222","a.ono@scchr.jp",{"facility":323,"status":250,"city":324,"state":325,"zip":326,"country":253,"countryCode":254,"cosmosGeoPoint":15,"geoPoint":15,"contacts":327},"National Cancer Center Hospital","Chuo-ku","Tokyo","104-0045",[328],{"name":329,"role":157,"phone":330,"phoneExt":15,"email":331},"Yuki Shinno, MD","+81-3-3542-2511","yshinno@ncc.go.jp",{"facility":333,"status":250,"city":334,"state":325,"zip":335,"country":253,"countryCode":254,"cosmosGeoPoint":15,"geoPoint":15,"contacts":336},"The Cancer Institute Hospital of JFCR","Koto-ku","135-8550",[337],{"name":338,"role":157,"phone":339,"phoneExt":15,"email":340},"Shigehisa Kitano, MD","+81-3-3520-0111","shigehisa.kitano@jfcr.or.jp",{"facility":342,"status":250,"city":343,"state":15,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":344,"geoPoint":348,"contacts":349},"National Hospital Organization Kyushu Cancer Center","Fukuoka",{"type":170,"coordinates":345},[346,347],130.41667,33.6,{"lat":347,"lon":346},[350],{"name":351,"role":157,"phone":352,"phoneExt":15,"email":159},"Masafumi Yamaguchi, MD","+81-92-541-3231",{"facility":354,"status":250,"city":355,"state":15,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Kanagawa Cancer Center","Kanagawa",{"type":170,"coordinates":357},[358,359],139.91667,37.58333,{"lat":359,"lon":358},[362],{"name":363,"role":157,"phone":364,"phoneExt":15,"email":365},"Shuji Murakami, MD","+81-45-520-2222","murakami.0260j@kanagawa-pho.jp",{"facility":367,"status":250,"city":276,"state":15,"zip":15,"country":253,"countryCode":254,"cosmosGeoPoint":368,"geoPoint":370,"contacts":371},"Kurashiki Central Hospital",{"type":170,"coordinates":369},[280,281],{"lat":281,"lon":280},[372],{"name":373,"role":157,"phone":374,"phoneExt":15,"email":375},"Toshihide Yokoyama, MD","+81-86-422-0210","ty14401@kchnet.or.jp",{"facility":377,"status":250,"city":378,"state":15,"zip":15,"country":379,"countryCode":15,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"Samsung Medical Center","Seoul","South Korea",{"type":170,"coordinates":381},[382,383],126.9784,37.566,{"lat":383,"lon":382},[386],{"name":387,"role":157,"phone":388,"phoneExt":15,"email":389},"Jong-Mu Sun, MD","+82-02-3410-6518","tntntn3@gmail.com",{"type":391,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR",[393],{"name":394,"class":6},"Linical Co., Ltd.","100414948",false,"NCT04683250","Study of RET Inhibitor TAS0953\u002FHM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","Phase I\u002FII Study of the Selective RET Inhibitor TAS0953\u002FHM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities","MARGARET","Ages Eligible for Study:\n\n\\- Adult patient (The definition of adulthood shall comply with the regulatory requirements of each region)\n\nInclusion Criteria:\n\nPhase I - Common inclusion criteria for Dose-Escalation \u002F Dose-Expansion:\n\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\n* 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.\n* Adequate hematopoietic, hepatic and renal function\n\nPhase I Dose-Escalation - Specific inclusion criteria:\n\n* Advanced solid tumors\n* Measurable and\u002For non-measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases, (s)he should be asymptomatic.\n\nPhase I Dose-Expansion - Specific inclusion criteria:\n\n* Patient with RET gene fusion :\n\n  * 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.\n  * Cohort 2, 4: locally advanced or metastatic NSCLC patients with RET gene fusion and prior exposure to RET selective inhibitors.\n* Measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases,(s)he should have:\n\n  * asymptomatic untreated brain\u002Fleptomeningeal metastases off steroids and anticonvulsant for at least 7 days or\n  * 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.\n\nPhase II :\n\n* Available RET-gene abnormalities determined on tissue or liquid biopsy\n* Locally advanced or metastatic:\n\n  * NSCLC patients with primary RET gene fusion and prior exposure to RET selective inhibitors;\n  * NSCLC patients with RET gene fusion and without prior exposure to RET selective inhibitors\n  * 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\n* Eastern Cooperative Oncology Group (ECOG) performance score of 0-2\n* Measurable disease as determined by RECIST 1.1\n* If patient has brain and\u002For leptomeningeal metastases,(s)he should have:\n\n  * asymptomatic untreated brain\u002Fleptomeningeal metastases off steroids and anticonvulsant for at least 7 days or\n  * 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.\n* Adequate hematopoietic, hepatic and renal function\n\nExclusion Criteria:\n\nCommon exclusion criteria for Phase 1 and Phase 2\n\n* Investigational agents or anticancer therapy within 5 half-lives prior to the first dose of study drug\n* 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.\n* 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.\n* 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.\n* 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\n* 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.\n\nPhase I Dose-Expansion - and Phase II specific exclusion criteria:\n\n* Presence of known EGFR, KRAS, ALK, HER2, ROS1, BRAF and METex14 activating mutations.","ALL","18 Years",{"count":405,"type":406},244,"ESTIMATED","INTERVENTIONAL",[409,410],"PHASE1","PHASE2","Phase 1 and 2 trial to study the safety, pharmacokinetics, and efficacy of TAS0953\u002FHM06 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.",[413,414],"RET-altered Non Small Cell Lung Cancer","RET-altered Solid Tumors","2026-02-28",{"date":417,"type":418},"2026-03-03","ACTUAL",{"date":420,"type":418},"2020-12-16",{"date":422,"type":406},"2031-03",{"name":5,"class":6},21]