[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cogent Biosciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":263},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,40,58,103,111,118,154,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":23,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":36,"locationsCount":39},"100053613","expanded-access-to-bezuclastinib-for-patients-with-nonadvanced-systemic-mastocytosis-or-advanced-systemic-mastocytosis-100053613",false,"NCT06915766","Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis","Intermediate-Size Patient Population Expanded Access to Bezuclastinib for Patients With NonAdvanced Systemic Mastocytosis or Advanced Systemic Mastocytosis","Key Inclusion Criteria:\n\n* Able to provide written informed consent and commit to EAP assessments.\n* ≥18 years of age.\n* Able to swallow tablets.\n* Diagnosed with ASM, SM-AHN, MCL, BMM, ISM, or SSM according to the 2022 WHO Classification for SM\n* Not receiving adequate disease control on current therapy(ies).\n* Have clinically acceptable laboratory screening results.\n\nExclusion Criteria:\n\n* Patients who are eligible for and\u002For enrolled in an on-going bezuclastinib clinical trial.\n* Patients who discontinued investigational use of bezuclastinib in previous clinical trials due to toxicity or withdrawal of consent.\n* Pregnant or currently breastfeeding.\n* Prior or ongoing clinically significant illness or medical or physical condition\n\nOther protocol-defined criteria apply.","ALL","18 Years","EXPANDED_ACCESS","The purpose of this expanded access program (EAP) protocol is to provide investigational bezuclastinib to patients with a diagnosis of nonadvanced systemic mastocytosis (NonAdvSM) or advanced systemic mastocytosis (AdvSM) who have received and failed or been intolerant to at least one standard approved therapy and\u002For have no comparable or satisfactory alternative therapy options.",[21,22],"Systemic Mastocytoses, Indolent","Systemic Mastocytoses, Aggressive",[24,25,26,27,28,29,30],"Systemic Mastocytosis","NonAdvanced Systemic Mastocytosis","Advanced Systemic Mastocytosis","Systemic Mastocytosis with an associated hematologic neoplasm (SM-AHN)","Aggressive Systemic Mastocytosis (ASM)","Mast Cell Leukemia (MCL)","Bone Marrow Mastocytosis (BMM)","AVAILABLE","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"name":37,"class":38},"Cogent Biosciences, Inc.","INDUSTRY",23,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":55,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":56,"locationsCount":57},"100053309","expanded-access-to-bezuclastinib-to-be-coadministered-with-sunitinib-for-patients-with-gastrointestinal-stromal-tumors-100053309","NCT06948955","Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Gastrointestinal Stromal Tumors","Expanded Access to Bezuclastinib to be Coadministered With Sunitinib for Patients With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors","Inclusion Criteria:\n\n* Able to provide written informed consent and commit to recommended EAP assessments.\n* ≥18 years of age.\n* Able to swallow tablets.\n* Histologically confirmed locally advanced, metastatic, and\u002For unresectable GIST.\n* Intolerant to imatinib or received prior imatinib therapy for treatment of advanced, metastatic, and\u002For unresectable GIST that resulted in disease progression.\n* Meet clinically acceptable local laboratory results.\n\nExclusion Criteria:\n\n* Patients who are eligible for and capable of participating in and\u002For enrolled in an on-going bezuclastinib clinical trial.\n* Prior or known intolerance to sunitinib.\n* Patients who have previously participated in a bezuclastinib clinical trial.\n* Patients with persistent \\> Grade 2 toxicities from prior therapy.\n* Known PDGFR driving mutations or known SDH deficiency.\n* Pregnant or currently breastfeeding.\n\nOther protocol-defined criteria apply.","The purpose of this expanded access program (EAP) is to provide investigational bezuclastinib so that it can be coadministered with sunitinib to patients with a diagnosis of gastrointestinal stromal tumors (GIST) with no comparable or satisfactory alternative therapy options. The combination of bezuclastinib and sunitinib provides broad inhibition of all primary and secondary KIT mutations that commonly occur in GIST.",[49],"Gastrointestinal Neoplasms, Gastrointestinal Stromal Tumors",[51,52,53,54],"Solid Tumors","Sunitinib","Bezuclastinib","Gastrointestinal Stromal Tumors",{"date":34,"type":35},{"name":37,"class":38},26,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":4,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":78,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},"100622429","phase-1-a-study-of-mutant-selective-inhibitor-cgt6297-in-patients-with-advanced-solid-tumors-100622429","NCT07383506","A Study of Mutant Selective-Inhibitor (CGT6297), in Patients With Advanced Solid Tumors","A Study of a Mutant-Selective Inhibitor, CGT6297, in Patients With Advanced Solid Tumors Harboring PIK3CA Mutations","Inclusion Criteria:\n\n1. Histologically confirmed advanced solid tumor harboring oncogenic PIK3CA mutations in blood and\u002For tumor:\n\n   1. Phase 1b Cohort 1, participants must have PIK3CA endometrial cancer\n   2. Phase 1b Cohort 2, participants must have HR-positive\u002FHER2-negative or HER2-low breast cancer (immunohistochemistry \\[IHC\\] and in-situ hybridization results must meet ASCO-College of American Pathology guidelines for breast cancer or criteria)\n   3. Phase 1b Cohort 3 will allow all solid tumors that do not meet criteria for Phase 1b Cohorts 1 or 2, including head and neck cancers, other gynecological cancers, colorectal cancers harboring PIK3CA mutations\n2. Meet prior treatment requirement of:\n\n   1. Phase 1a: previously treated with and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit for their condition.\n   2. Phase 1b: previously treated with or considered not appropriate for SOC first-line treatment for their condition\n3. Have at least one measurable lesion according to RECIST v1.1.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1\n5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n6. Resolution of acute toxicities from prior anticancer therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities (other than parameters specified in screening testing as outlined below), as determined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCICTCAE) v5.0.\n7. Have an ejection fraction ≥50%\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug\n3. Treatment with radiotherapy ≤2 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease\n5. Ongoing or planned long-term (≥4 consecutive weeks) treatment with glucocorticoid steroids at greater than physiologic dosing (defined as equivalent to \\>20 mg\u002Fday prednisone)\n6. Diagnosis of diabetes mellitus type 1 or uncontrolled diabetes mellitus type 2 (defined as fasting glucose ≥140 mg\u002FdL and HbA1c ≥7.0%; antihyperglycemic medical management permitted with the exception of insulin)\n7. Previous molecular testing (NGS or PCR) showed tumor with the following mutations: mutations\u002Fdeletions in PTEN or activating mutations in AKT, HRAS\u002FKRAS\u002FNRAS, EGFR, and BRAF",{"count":66,"type":67},90,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is a Phase 1, two-part, open-label, nonrandomized, dose-escalation and signal-seeking study of CGT6297, evaluating the safety, tolerability, PK, pharmacodynamic (what the drug does to the body), and antitumor activity of CGT6297 in adult participants with advanced solid tumors harboring PIK3CA mutations",[73,74,75,76,77],"PIK3CA Mutations","Advanced Solid Tumors, Adult","Endometrial Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","HER2-low Breast Cancer",[79,80,81,82,73,83,75,84,85,86,87,88,89,90,91,77,92],"HER2","PI3K","Mutant-Selective Inhibitor","Advanced solid tumors","PIK3CA SNVs","Breast Cancer","HR+\u002FHER2 Negative breast cancer","HR+\u002FHER2 (-) breast cancer","HR+\u002FHER2 low breast cancer","PI3KCA Genetic Alterations","PI3KCA Point Mutations","PI3KCA Gene Short Variants","PI3KCA active alteration","Phase 1a\u002F1b","RECRUITING","2026-06-30",{"date":96,"type":35},"2026-07-01",{"date":98,"type":67},"2026-06",{"date":100,"type":67},"2029-08",{"name":37,"class":38},4,{"id":104,"slug":4,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":47,"conditions":105,"keywords":106,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":110,"locationsCount":39},"100589018",[49],[51,52,53,54],"2026-06-22",{"date":109,"type":35},"2026-06-23",{"name":37,"class":38},{"id":112,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":113,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":115,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":116,"locationsCount":117},"100586468",[21,22],[24,25,26,27,28,29,30],{"date":109,"type":35},{"name":37,"class":38},22,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":68,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100455246","phase-3-peak-a-phase-3-randomized-trial-of-cgt9486sunitinib-vs-sunitinib-in-subjects-with-gastrointestinal-stromal-tumors-100455246","NCT05208047","(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors","A Phase 3 Randomized, Open-Label, Multicenter Clinical Study of CGT9486+Sunitinib vs. Sunitinib in Subjects With Locally Advanced, Unresectable, or Metastatic Gastrointestinal Stromal Tumors","Key Inclusion Criteria:\n\n1. Histologically confirmed locally advanced, metastatic, and\u002For unresectable GIST. Molecular pathology report must be available for Part 2; if molecular pathology report is unavailable or inadequate, an archival or fresh tumor tissue sample will be required to evaluate mutational status prior to randomization. (GIST 1L Substudy: must have documented mutation in KIT Exon 9 with an available molecular pathology report; archival or fresh tumor tissue sample will be required)\n2. Documented disease progression on or intolerance to imatinib (Part 1a, Part 1b, Part 2, DDI Substudy)\n3. Subjects must have received the following treatment:\n\n   * DDI Substudy\u002FPart 1a: Treatment with ≥1 prior lines of therapy for GIST\n   * Part 1b: Treatment with ≥2 prior TKI for GISTs\n   * Part 2: Prior treatment with imatinib only\n   * GIST 1L Substudy: No prior systemic therapy for GIST including adjuvant therapy. Exception: up to 10 subjects with ongoing imatinib therapy of ≤4 weeks\n4. Have at least 1 measurable lesion according to mRECIST v1.1 (Part1a, Part 1b, Part 2, GIST 1L Substudy)\n5. Eastern Cooperative Oncology Group (ECOG) Status\n\n   * 0 to 2 (Part 1a, Part 1b, Part 2, DDI Substudy)\n   * 0 to 1 (GIST 1L Substudy)\n6. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits\n\nKey Exclusion Criteria:\n\n1. Known Platelet-Derived Growth Factor Receptor (PDGFR) driving mutations or known succinate dehydrogenase deficiency (Part 1a, Part 1b, Part 2, DDI Substudy)\n2. Clinically significant cardiac disease\n3. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug (Part 1a, Part 1b, Part 2, DDI Substudy)\n4. Gastrointestinal abnormalities including, but not limited to, significant nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption\n5. Any active bleeding excluding hemorrhoidal or gum bleeding\n6. Seropositive for HIV 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody.\n7. Active, uncontrolled, systemic bacterial, fungal, or viral infections at Screening\n8. Received strong CYP3A4 inhibitors or inducers (Part 1a, Part 1b, Part 2, DDI Substudy)\n9. Received sunitinib within 3 weeks (Part 1a, Part 1b, DDI Substudy)",{"count":126,"type":67},482,[128],"PHASE3","This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination with sunitinib. This is a multi-part study that will enroll approximately 482 patients. Part 1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to be used in subsequent parts in approximately 20 patients who have received at least one prior line of therapy for Gastrointestinal Stromal Tumors (GIST) and 2) evaluating the potential for drug-drug interactions between CGT9486 and sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388 patients who are intolerant to, or who failed prior treatment with imatinib only and will compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being randomized in a 1:1 manner. This study also contains two substudies: 1) a drug-drug interactions (DDI) substudy will investigate the potential for CGT9486 to be a Cytochrome P450 (CYP)3A4 inducer in approximately 16 patients who have received at least one prior line of therapy for GIST and 2) a substudy intended to test the efficacy of bezuclastinib and sunitinib as first-line (1L) treatment of GIST in approximately 40 participants with KIT exon 9 mutations and no prior systemic therapy (with the exception of up to 10 subjects with ongoing imatinib therapy of ≤4 weeks).",[131,132],"Advanced Gastrointestinal Stromal Tumors","Metastatic Cancer",[52,51,54,134,135,136,137,138,139,140,141,53,142,143,144],"Gastrointestinal","KIT","Kinase Inhibitors","Growth Inhibitors","CGT9486","Unresectable","Metastatic","GIST","PLX9486","Midazolam","Drug-drug interaction","2026-06-12",{"date":147,"type":35},"2026-06-16",{"date":149,"type":35},"2022-04-14",{"date":151,"type":67},"2030-01",{"name":37,"class":38},126,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":68,"phases":163,"briefSummary":165,"conditions":166,"keywords":169,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100439021","phase-2-apex-bezuclastinib-in-patients-with-advanced-systemic-mastocytosis-100439021","NCT04996875","(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis","A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis","Key Inclusion Criteria for Main Study:\n\n1. Diagnosed with one of the following advanced mastocytosis diagnoses by Eligibility Committee\n\n   1. Aggressive Systemic Mastocytosis (ASM)\n   2. Systemic Mastocytosis with an Associated Hematologic Neoplasm (SM-AHN)\n   3. Mast Cell Leukemia (MCL)\n2. Measurable disease according to modified IWG-MRT-ECNM criteria. (A subset of patients inevaluble per mIWG-MRT-ECNM will be included in the study).\n3. ECOG (0 to 3)\n4. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits\n\nKey Exclusion Criteria for Main Study:\n\n1. Persistent toxicity from previous therapy for AdvSM that has not resolved to ≤ Grade 1\n2. Associated hematologic neoplasm requiring immediate antineoplastic therapy\n3. Clinically significant cardiac disease\n4. Known positivity for the FIP1L1 PDGFRA fusion. Patients with eosinophilia without detectable KIT D816V mutation must demonstrate lack of PDGFRA fusion mutation prior to enrollment\n5. Seropositive for human immunodeficiency virus (HIV) 1 or 2, or positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody\n6. History of clinically significant bleeding event within 30 days before the first dose of study drug or need for therapeutic anticoagulation on study\n7. Diagnosed with or treated for malignancy other than the disease under study within the prior 3 years before enrollment\n8. Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening bone marrow biopsy\n9. Received hematopoietic growth factor support within 14 days before the first dose of study drug\n10. Received strong CYP3A4 inhibitors or inducers within 14 days or 5 drug half-lives, whichever is longer, before the first dose of study drug\n11. Need for treatment with high dose steroids\n\nKey Inclusion Criteria for Substudy Population:\n\nRollover Cohort\n\n1. Demonstrate AHN progression requiring immediate AHN-directed therapy while receiving bezuclastinib\n2. Demonstrated clinical benefit from bezuclastinib therapy\n3. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits\n\nHigh-Risk Cohort\n\n1. Receiving or indicated for AHN-directed therapy.\n2. Diagnosed with one of the following pathologic diagnoses of SM-AHN:\n\n   1. Myelodysplastic syndrome (MDS) that is high- or very high-risk\n   2. Accelerated phase myeloproliferative neoplasm (MPN)\n   3. MDS with excessive blasts in bone marrow or peripheral blood\n   4. Chronic myelomonocytic leukemia-2 (CMML-2)\n3. Have clinically acceptable local laboratory screening results (clinical chemistry, hematology) within certain limits.\n\nKey Exclusion Criteria for Substudy Population:\n\n1. Diagnosis of Philadelphia chromosome-positive malignancy\n2. Diagnosis of acute myeloid leukemia (AML)\n3. Appropriate for allogenic hematopoietic stem cell transplantation\n4. Any contraindication to selected concomitant therapy\n5. Rollover Cohort: Have not demonstrated acceptable tolerability of previous bezuclastinib therapy\n6. High-Risk Cohort: Previously treated with investigational therapy for AdvSM\n7. High-Risk Cohort: Previously treated with cytoreductive therapy and discontinued due to treatment-related toxicity\n8. High-Risk Cohort: Received any cytoreductive therapy or any investigational agent less than 14 days, and for cladribine, interferon alpha, pegylated interferon, and any antibody therapy less than 28 days, before screening or archival bone marrow biopsy",{"count":162,"type":67},140,[164],"PHASE2","This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).",[167,168,29,28],"Advanced Systemic Mastocytosis (AdvSM)","SM With an Associated Hematologic Neoplasm (SM-AHN)",[170,24,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,138,196,197,198,199,200,201,202,203,204,205,206,207,208],"Mastocytosis","Advanced Mastocytosis","Aggressive Mastocytosis","Hematologic Neoplasms","Mast Cell","Mast Cell Leukemia","Soft Tissue Neoplasms","Neoplasms by site","Skin Diseases","Immune Complex Diseases","Immune System Diseases","Hypersensitivity","Hematologic Diseases","Leukemia","Myeloid Leukemia","Acute Myeloid Leukemia","SM with Associated Hematologic Neoplasm","AdvSM","ASM","SM-AHN","MCL","Neoplasm","D816V","KIT D816V","AML","bezuclastinib","CGT","PLX","Connective Tissue Neoplasms","Urticaria Pigmentosa","High-risk myelodysplastic syndrome","Chronic myelomonocytic leukemia","Myeloproliferative neoplasm","High-risk myeloid neoplasm","High-risk MDS","MPN","High-risk MPN","Accelerated phase MPN","CMML","2026-04-29",{"date":211,"type":35},"2026-05-05",{"date":213,"type":35},"2021-11-09",{"date":215,"type":67},"2027-07",{"name":37,"class":38},42,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":68,"phases":227,"briefSummary":228,"conditions":229,"keywords":235,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100620741","phase-1-a-study-of-a-selective-erbb2-inhibitor-cgt4255-in-patients-with-advanced-solid-tumors-100620741","NCT07361562","A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors","A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression","Inclusion Criteria:\n\n1. Have histologically confirmed diagnosis of:\n\n   1. Part A: Locally advanced, metastatic, and\u002For unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and\u002For tumor or HER2 overexpression in tumor\n   2. Part B: Locally advanced, metastatic, and\u002For unresectable NSCLC with documented ERBB2 mutation in blood and\u002For tumor\n   3. Part C: Locally advanced, metastatic and\u002For unresectable breast cancer with documented ERBB2 mutation in blood and\u002For tumor or HER overexpression in tumor\n2. Have measurable disease per RECIST v1.1.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2.\n4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.\n\nExclusion Criteria:\n\n1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.\n2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug.\n3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug.\n4. Clinically significant cardiac disease.\n5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug.\n6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.",{"count":226,"type":67},100,[70],"This is an open-label, phase 1\u002F1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.",[230,231,232,233,234,79],"Advanced Solid Tumor, Adult","ERBB2 Altered Breast Cancer","ERBB2 Gene Amplification","HER2 Overexpression","Non-Small Cell Lung Cancer",[236,237,238,239,240,241,242,243,244,245,246,247,248,249,250,251,252,253,79],"ERBB2 genetic alterations","Investigational Drug","Advanced Solid Tumors","ERBB2 Mutated Non Small Cell Lung Cancer","Mutated Advanced Solid Tumors","ERBB2 Brain Metastases","ERRB2 Point Mutations","ERBB2 Gene Short Variants","ERBB2 Gene Rearrangements","ERBB2 activation alteration","ERBB2 gene copy number amplifications","ERBB2 gene insertions","ERRB2 gene deletions","ERBB2 gene fusions","NRG1 gene fusions","ERBB2 indel","Phase 1\u002F1b","HER2 Protein Overexpression","2026-02-25",{"date":256,"type":35},"2026-02-27",{"date":258,"type":35},"2025-12-30",{"date":260,"type":67},"2028-11",{"name":37,"class":38},6,""]