[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Turning Point Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":126},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":87},"100292920","phase-1-a-study-of-repotrectinib-tpx-0005-in-patients-with-advanced-solid-tumors-harboring-alk-ros1-or-ntrk1-3-rearrangements-100292920",false,"NCT03093116","A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements","A Phase 1\u002F2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)","TRIDENT-1","PHASE 1\n\nKey Inclusion Criteria:\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) (Stage IV, American Joint Committee on Cancer v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.\n2. ECOG PS 0-1.\n3. Age ≥18 (or age ≥ 20 of age as required by local regulation).\n4. Capability to swallow capsules intact (without chewing, crushing, or opening).\n5. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.\n6. Prior cytotoxic chemotherapy is allowed.\n7. Prior immunotherapy is allowed.\n8. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.\n9. Patients with asymptomatic CNS metastases (treated or untreated) and\u002For asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.\n10. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500\u002Fmm3 (1.5 × 109\u002FL); Platelets (PLTs) ≥100,000\u002Fmm3 (100 × 109\u002FL); Hemoglobin ≥ 9.0 g\u002FdL transfusions are allowed; Serum creatinine or creatinine clearance Within normal limits or \\> 40 mL\u002Fmin; Total serum bilirubin \\\u003C 1.5 × ULN; Liver transaminases (ASTs\u002FALTs) \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver and\u002For bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation\n11. Life expectancy ≥ 3 months.\n\nPHASE 2 Key Inclusion Criteria\n\n1. Histologically or cytologically confirmed diagnosis of locally advanced, or metastatic solid tumor (including primary CNS tumors) that harbors a ROS1, or NTRK1-3 gene fusion.\n2. Subject must have a documented ROS1 or NTRK1-3 gene fusion determined by tissue-based local testing using either:\n\n   1. a next-generation sequencing (NGS) or quantitative polymerase chain reaction (qPCR) test will be accepted to determine molecular eligibility.\n\n      • Adequate tumor tissue needs to be sent to the Sponsor designated central diagnostic laboratory for retrospective confirmation by a central diagnostic laboratory test selected by the Sponsor.\n\n      OR\n   2. a fluorescence in situ hybridization (FISH) test AND prospective confirmation of fusion status by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment will be accepted to determine molecular eligibility.\n\n      * Adequate tumor tissue must be sent to the Sponsor designated central diagnostic laboratory for prospective confirmation by a central diagnostic laboratory test selected by the Sponsor PRIOR to enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.\n4. Age ≥12 (or age ≥ 20 as required by local regulation).\n5. Willing and able to provide written institutional review board (IRB)\u002Finstitutional ethics committee-approved Informed Consent or an Assent signed by a parent or legal guardian for subjects age 12 to 17.\n6. At least 1 measurable target lesion according to RECIST (v1.1) prospectively confirmed by Blinded Independent Central Radiology Review (BICR), selected by Sponsor, PRIOR to enrollment. Subjects with CNS-only measurable disease ≥10 mm as defined by RECIST (v1.1) are eligible.\n7. Subjects with advanced solid tumors harboring ROS1, NTRK1, NTRK2, or NTRK3 rearrangement will be assigned into 6 distinct expansion (EXP) cohorts provided all inclusion and exclusion criteria are met.\n\n   i. EXP-1: ROS1 TKI-naïve ROS1+ NSCLC ii. EXP-2: 1 Prior ROS1 TKI and 1 Platinum based chemo ROS1+ NSCLC iii. EXP-3: 2 Prior ROS1 TKIs ROS1+ NSCLC (No Chemo or IO) iv. EXP-4: 1 Prior ROS1 TKI ROS1+ NSCLC (No Chemo or IO) v. EXP-5: TRK TKI-naïve NTRK+ solid tumors vi. EXP-6: TRK TKI-pretreated NTRK+ solid tumors\n8. Subjects with asymptomatic CNS metastases (treated or untreated) and\u002For asymptomatic leptomeningeal carcinomatosis are eligible to enroll if they satisfy the protocol specified criteria.\n9. Baseline laboratory values fulfilling the following requirements:Absolute neutrophils count (ANC) ≥1500\u002Fmm3 (1.5 × 109\u002FL); Platelets (PLTs) ≥100,000\u002Fmm3 (100 × 109\u002FL); Hemoglobin ≥ 9.0 g\u002FdL transfusions are allowed; Serum creatinine or creatinine clearance \\> 40 mL\u002Fmin; Total serum bilirubin \\\u003C 1.5 × ULN; Liver transaminases (ASTs\u002FALTs) \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver metastases are present Alkaline phosphatase (ALP); \\\u003C 2.5 × ULN; \\\u003C 5 × ULN if liver and\u002For bone metastasis are present; Serum calcium, magnesium, and potassium Normal or CTCAE grade ≤ 1 with or without supplementation\n10. Life expectancy ≥ 3 months.\n\nKey Exclusion Criteria PHASE 1 and PHASE 2\n\n1. Concurrent participation in another therapeutic clinical trial.\n2. Symptomatic brain metastases or leptomeningeal involvement.\n3. History of previous cancer, except for squamous cell or basal-cell carcinoma of the skin, or any in situ carcinoma that has been completely resected, requiring therapy within the previous 2 years.\n4. Major surgery within 4 weeks of start of repotrectinib treatment. Radiation therapy (except palliative to relieve bone pain) within 2 weeks of study entry. Palliative radiation (≤10 fractions) must have been completed at least 48 hours prior to study entry\n5. Clinically significant cardiovascular disease (either active or within 6 months prior to enrollment): myocardial infarction, unstable angina, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II), cerebrovascular accident or transient ischemic attack, symptomatic bradycardia, requirement for anti-arrhythmic medication. Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2\n6. Any of the following cardiac criteria:\n\n   Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTcF) \\> 470 msec obtained from 3 ECGs, using the screening clinic ECG machine-derived QTc value Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 msec) Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval.\n7. Known active infections (bacterial, fungal, viral including HIV positivity).\n8. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.\n9. Peripheral neuropathy of CTCAE ≥grade 2.\n10. History of extensive, disseminated, bilateral, or presence of CTCAE grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis, and pulmonary fibrosis. Subjects with history of prior radiation pneumonitis are not excluded.","ALL","12 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.\n\nMidazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.\n\nPhase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.",[28,29],"Locally Advanced Solid Tumors","Metastatic Solid Tumors",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,15,69,70,71,72,73,74],"ALK","ROS1","NTRK","Sarcoma","Lung Neoplasms","Carcinoma, NSCL","NSCLC","Non Small Cell Lung","Thyroid Disease","Colonic Neoplasms","Thyroid Neoplasms","Carcinoma, Neuroendocrine","Respiratory Tract Neoplasms","Thoracic Neoplasms","Neoplasms by Site","Neoplasms","Lung Disease","Respiratory Tract Disease","Carcinoma, Bronchogenic","Bronchial Neoplasms","Endocrine System Disease","Colorectol Neoplasms","Intestinal Neoplasms","Gastrointestinal Neoplasms","Digestive System Neoplasms","Gastrointestinal Disease","Colonic Disease","Intestinal Disease","Endocrine Gland Neoplasms","Head and Neck Neoplasms","Neuroendocrine Tumors","Neuroectodermal Tumors","Neoplasms, Germ Cell and Embryonal","Neoplasms by Histologic Type","Adenocarcinoma","Non Small Cell Lung Cancer","Solid Tumors","Rearrangements","TKI","TKI naive","TKI pretreated","Anti-tumor activity","Repotrectinib","Advanced Solid Malignancies","RECRUITING","2026-05-26",{"date":78,"type":79},"2026-05-27","ACTUAL",{"date":81,"type":79},"2017-03-07",{"date":83,"type":21},"2028-02-29",{"name":85,"class":86},"Turning Point Therapeutics, Inc.","INDUSTRY",165,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100369766","phase-1-a-study-of-repotrectinib-in-pediatric-and-young-adult-subjects-harboring-alk-ros1-or-ntrk1-3-alterations-100369766","NCT04094610","A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations","A Phase 1\u002F2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations","Key Inclusion Criteria:\n\n1. Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.\n2. Phase 1: Age \\\u003C12 years; Phase 2: Age 12- 25 years\n3. Prior cytotoxic chemotherapy is allowed.\n4. Prior immunotherapy is allowed.\n5. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.\n6. All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.\n7. Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.\n8. Subjects must have a Lansky (\\\u003C 16 years) or Karnofsky (≥ 16 years) score of at least 50.\n9. Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.\n10. Adequate hematologic, renal and hepatic function.\n\nPhase 2 Inclusion Criteria:\n\n1. Cohort Specific Inclusion Criteria:\n\n   * Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve;\n   * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated;\n   * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.\n2. Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment.\n\nKey Exclusion Criteria (Phase 1 and Phase 2):\n\n1. Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.\n2. Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.\n3. Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).\n4. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.\n5. Any of the following cardiac criteria:\n\n   * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \\> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value\n   * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \\> 250 msec)\n   * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval\n6. Peripheral neuropathy of CTCAE ≥grade 2.\n7. Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.\n8. Any potential allergies to repotrectinib and\u002For its excipients.","25 Years",{"count":97,"type":21},75,[24,25],"Phase 1 will evaluate the safety and tolerability at different dose levels of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring anaplastic lymphoma kinase (ALK), receptor tyrosine kinase encoded by the gene ROS1 (ROS1), or neurotrophic receptor kinase genes encoding TRK kinase family (NTRK1-3) alterations to estimate the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) and select the Pediatric Recommended Phase 2 Dose (RP2D).\n\nPhase 2 will determine the anti-tumor activity of repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ROS1 or NTRK1-3 alterations.",[28,29,101,102],"Lymphoma","Primary CNS Tumors",[31,32,104,105,106,107,108,109,110,111,112,113,114,115,116],"NTRK1-3","Primary CNS tumor","anaplastic large cell lymphoma","metastatic solid tumor","advanced solid tumor","sarcoma","infantile fibrosarcoma","glioblastoma","soft tissue schwannoma","solitary fibrous tumor","glioma","inflammatory myofibroblastic tumor","pediatric","2025-11-18",{"date":119,"type":79},"2025-11-19",{"date":121,"type":79},"2020-03-12",{"date":123,"type":21},"2027-09-30",{"name":85,"class":86},68,""]