[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Pierre Fabre Medicament\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":162},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,67,112,139],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100559659","phase-1-study-of-fih-of-stx-241-in-locally-advanced-or-metastatic-nsclc-resistant-to-egfr-tkis-100559659",false,"NCT06567015","Study of FIH of STX-241 in Locally Advanced or Metastatic NSCLC Resistant to EGFR TKIs","Phase I\u002FII First-In-Human Open-label Trial to Assess Safety and Efficacy of STX-241 in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Resistant to EGFR Tyrosine Kinase Inhibitors (TKIs).","STX-241 FIH","Inclusion Criteria:\n\n1. Signed and dated informed consent for participation in the trial obtained according to International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP), and national\u002Flocal regulations.\n2. Male or female ≥ 18 years of age at the time of signing informed consent but at least of legal age in their country.\n3. Histological confirmation of locally advanced or metastatic, EGFR-mutant (ex19del or L858R mutations) non-small cell lung cancer (NSCLC) Stage IIIB\u002FC or IV (AJCC 8th edition) not eligible for curative intent surgery or chemoradiation.\n4. Part 1 Disease progression on a 3rd generation EGFR TKI-based therapy (monotherapy or in combination) received at any prior line of treatment.\n\n   Part 2: Disease progression after a 3rd generation EGFR TKI-based therapy (monotherapy or combination) given as first or second line of systemic anti-cancer therapy and no more than 2 prior lines of systemic anti-cancer therapy.\n5. Tumor mutation profile:\n\n   * Part 1 (backfilling component): Presence of C797X and absence of T790M mutations documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on treatment with 3rd generation EGFR TKI.\n   * Part 2: Presence of C79X mutation documented locally (as part of clinical practice) on a sample (blood or tissue) collected after progression on a 3rd generation EGFR TKI-based therapy.\n6. Part 1 (Backfilling component), Part 2: At least one measurable target lesion according to RECIST v1.1.\n7. Eastern cooperative oncology group (ECOG) performance status 0-1.\n8. Adequate organ function as defined below:\n\n   * Absolute neutrophil count (ANC) ≥ 1.5 x 10\\^9\u002FL\n   * Platelets ≥ 75 x 10\\^9\u002FL\n   * Hemoglobin ≥ 90 g\u002FL.\n   * Serum total bilirubin ≤ 1.5 x ULN or ≤ 3.0 × ULN for participants with documented Gilbert's syndrome.\n   * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 x ULN. If the participant has liver metastases, AST and ALT ≤5 × ULN.\n   * Estimated glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin by CKD-EPI equation\n9. Adequate cardiac function as defined below:\n\n   * Mean QT interval corrected for heart rate according to Fridericia's formula (QTcF) value ≤ 470 msec for women and ≤ 450 msec for men and no history of long QT syndrome or risk factors for torsade de pointe.\n   * Left ventricular ejection fraction (LVEF) ≥ 50% .\n   * Systolic blood pressure \\\u003C 150 mmHg and diastolic blood pressure \\\u003C 100 mmHg\n10. Female participants of childbearing potential:\n\n    * Negative highly sensitive serum β-HCG test performed within 7 days prior to first dose of STX-241 (C1D1) and a negative urine pregnancy test performed prior to C1D1.\n    * Agreement to use one highly effective contraceptive method (as defined in protocol and according to local regulations), starting at screening period, throughout the trial and until at least 182 days (i.e. more than 5 estimated STX- 241 half-lives (2 days) plus 6 months (180 days)) after the last dose of STX-241. If the highly effective method of contraception is a hormonal contraceptive method, it must be supplemented by one additional effective (barrier) method of contraception.\n    * Agreement to not donate eggs (ova, oocytes) for the purpose of assisted reproduction during the trial and for a period of 182 days after the last dose of STX-241.\n\n    Note: a female participant of childbearing potential is a woman who is not permanently sterilized or not postmenopausal (postmenopausal is defined as 12 months with no menses without an alternative medical cause).\n11. Male participants\u002Fpartners with female spouse\u002Fpartners of childbearing potential must agree to take appropriate precautions to avoid fathering a child, i.e.:\n\n    * Consistently use a barrier method \\[e.g., condom with spermicidal foam \u002F gel \u002F film \u002Fcream\u002Fsuppository\\], and his female partner use a highly effective method of contraception as defined in protocol and according to local regulations), starting at screening and continuing throughout the trial period and for 92 days (ie. more than 5 estimated STX-241 half-lives (2 days) plus 3 months (90 days)) after the last dose of STX-241.\n    * Not donate sperm from Day 1 (first administration of STX-241) until at least 92 days after the last dose of STX-241.\n\nNOTE: Other protocol defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n1. Part 1: Participants candidate for targeted therapies available to them (such as but not limited to therapies targeting ALK, BRAF, MET, NTRK, ROS1) as identified by local testing performed after progression to the last line of systemic therapy.\n\n   Part 2: Participants candidate for targeted therapies available to them such as, but not limited to: ALK, BRAF, MET (ex14 mutation and amplification), NTRK, ROSI, HER2 (mutations and amplification) as identified by local testing performed after progression to 3rd generation EGFR TKI-based therapy.\n2. Part 2: Participants who received 1st or 2nd generation EGFR TKIs.\n3. Participant with rapid progressive disease eligible to receive a platinum-based chemotherapy.\n4. Participant unable ingest or digest tablets. This can be caused by any impaired gastrointestinal function or disease, such as for example: ulcerative diseases, malabsorption syndrome, small bowel resection, ileus, etc. or any condition causing uncontrolled nausea, vomiting or diarrhea.\n5. History of a primary malignancy other than NSCLC with the exception of:\n\n   * Participants with a previous malignancy that completed all curative anticancer treatment at least 2 years before signing informed consent and with no evidence of residual disease from the prior malignancy at screening.\n   * Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate \\> 90%) that are adequately treated - Examples include, but are not limited to, completely resected basal cell carcinoma and squamous cell carcinoma of skin, melanoma in situ, curatively treated prostate cancer, breast cancer and early gastric cancer cured by endoscopic mucosal resection or endoscopic submucosal dissection.\n6. Spinal cord compression or CNS metastases that are associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for 2 weeks prior to enrollment in the trial.\n7. History of hypersensitivity to active or inactive ingredients of STX-241, or drugs with a similar chemical structure or from the same class.\n8. Active, bacterial, fungal, or viral infection, including, but not limited to: Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and known Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)-related illness, tuberculosis or an infection requiring systemic therapeutic treatment within 2 weeks prior to Day 1 (first administration of STX-241).\n\n   Note: Participants with known HIV infection are permitted if they have controlled infection (undetectable viral load \\[HIV ribonucleic acid polymerase chain reaction (PCR)\\] and CD4 count \\>350 either spontaneously or on a stable antiviral regimen). For participants with controlled HIV infection, monitoring will be performed per local standards.\n9. Positive SARs-CoV-2 or variants of SARs-CoV2 RT-PCR test or suspected to be infected with SARs-CoV2 or variants of SARsCoV2 with confirmation pending within 2 weeks of first dose of STX-241.\n10. Impaired cardiovascular function or clinically significant cardiovascular disease (either active or within 6 months prior to signing informed consent), including any of the following:\n\n    * Myocardial infarction, acute coronary syndromes including unstable angina, coronary\u002Fperipheral artery bypass graft, coronary angioplasty or stenting.\n    * Symptomatic congestive heart failure (New York Heart Association Classification Class ≥ II).\n    * Cerebrovascular accident or transient ischemic attack.\n    * Symptomatic bradycardia, requirement for anti-arrhythmic medication.\n    * Ongoing cardiac dysrhythmia of NCI-CTCAE Grade ≥2.\n11. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection or psychiatric illness\u002Fsocial situation that would limit compliance with trial requirements.\n12. Past medical history of Interstitial Lung Disease (ILD), drug-induced ILD, radiation pneumonitis that required steroid treatment, or any evidence of clinically active ILD.\n13. Past medical history of Stevens-Jonhson Syndrome (SJS) or Toxic epidermal necrolysis (TEN) or any evidence of clinically active SJS\u002FTEN.\n14. Women who are breast feeding.\n15. Prior anticancer therapy:\n\n    * EGFR-targeted TKI within 7 days prior to the first dose of STX-241.\n    * Any other systemic anticancer therapy within 28 days or 5 half-lives prior to the first dose of STX-241, whichever is the shortest, but with a minimum of 14 days in all circumstances.\n    * Radiotherapy to a large field or including a vital organ (including whole brain radiotherapy or stereotactic radiosurgery to brain) within 14 days before the first dose of STX-241.\n16. Live attenuated vaccine received within 30 days prior to the first dose of STX-241.\n17. Any toxicities from prior therapy with a NCI-CTCAE Grade ≥1 at the time of the first dose of STX-241 (C1D1). Exceptions include alopecia (any grade), fatigue with a Grade ≤2, and peripheral neuropathy with a Grade ≤2.\n18. Major surgical procedure within 14 days of the first dose of STX-241 (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures). Sequelae of surgical procedures must have resolved, including adequate wound healing, prior to the first dose of STX-241.\n19. Treatment with a prohibited medication or herbal remedy known to be strong CYP1A2 or CYP3A4 inducers, strong CYP1A2 or CYP3A4 inhibitors, sensitive CYP1A2, CYP2B6 and CYP3A4 substrates, sensitive MATE1 and OATP1B1 substrates and proton pump inhibitors (PPI) and H2 antagonists unless discontinued prior to the first administration of STX-241 within the following timeframe:\n\n    * At least 5 half-lives plus 14 days for strong CYP inducers.\n    * At least 5 half-lives for CYP inhibitors, CYP\u002Ftransporter substrates, proton pump inhibitor (PPI) and H2 antagonists.\n20. Participation in a clinical trial with administration of an investigational drug within 5 half-lives plus 14 days of the investigational drug, before the first dose of STX-241.\n21. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e. g, could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments.\n22. Employee or family member of the investigator or site staff.\n\nNOTE: Other protocol defined exclusion criteria may apply.","ALL","18 Years",{"count":20,"type":21},171,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The goal of this First-In-Human (FIH) Phase I\u002FII trial is to establish the safety profile, determine the Recommended Phase II Dose (RP2D), explore the pharmacokinetic (PK) exposure and pharmacodynamic (PD) properties as well as assess the efficacy of STX-241\u002FPFL-241, a mutant selective Central Nervous System (CNS)-penetrant fourth generation EGFR TKI, in participants with locally advanced or metastatic NSCLC that progressed during or following third generation EGFR TKI such as osimertinib due to C797X double acquired (secondary) mutations.",[28],"Non-small Cell Lung Cancer (NSCLC)",[30],"non-small cell lung cancer","RECRUITING","2026-05-20",{"date":34,"type":35},"2026-05-22","ACTUAL",{"date":37,"type":35},"2024-09-17",{"date":39,"type":21},"2030-07",{"name":41,"class":42},"Pierre Fabre Medicament","INDUSTRY",16,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100519459","phase-1-first-in-human-study-of-stx-721pfl-721-in-participants-with-locally-advanced-or-metastatic-non-small-cell-lung-cancer-harboring-egfr-or-her2-exon-20-insertion-mutations-100519459","NCT06043817","First-In-Human Study of STX-721\u002FPFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations","Key Inclusion Criteria:\n\n1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB\u002FC or IV not eligible for curative intent surgery or chemoradiation\n2. Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR\u002FHER2 exon 20 insertion mutations confirmed by qualified local laboratories\n3. Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of approved treatment for advanced or metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated\n4. Has documented tumor progression (based on radiological imaging)\n5. Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling\n6. Has at least one measurable tumor lesion per RECIST v1.1\n7. Is ≥18 years of age at the time of signing the ICF\n8. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1\n\nKey Exclusion Criteria:\n\n1. Has a tumor that is known to harbor EGFR ex20ins p.H773\\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and\u002For C797S resistance mutations\n2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC\n3. Has symptomatic brain or spinal metastases\n4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy\n5. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments",{"count":51,"type":21},345,[24,25],"Study STX-721-101\u002FPFL-721CI101 is an open label, Phase 1\u002F2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721\u002FPFL-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR or HER2 exon 20 insertion (ex20ins) mutations.",[55,56,57],"Non-Small Cell Lung Cancer","NSCLC","EGFR\u002FHER2 Exon 20 Insertion Mutation",[59],"Exon 20, EGFR, HER2, NSCLC, TKI",{"date":34,"type":35},{"date":62,"type":35},"2023-09-26",{"date":64,"type":21},"2029-12-01",{"name":41,"class":42},24,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100316038","phase-3-a-phase-3-study-of-tabelecleucel-for-participants-with-epstein-barr-virus-associated-post-transplant-lymphoproliferative-disease-after-failure-with-rituximab-or-rituximab-and-chemotherapy-100316038","NCT03394365","A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy","Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy","ALLELE","Inclusion Criteria:\n\n1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT).\n2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD.\n3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.\n4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For participants with treated central nervous system (CNS) disease, a head CT and\u002For brain\u002Fspinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.\n5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.\n6. Males and females of any age.\n7. Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants \\\u003C 16 years.\n8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the participant underwent transplant must be in morphologic remission.\n9. Adequate organ function.\n\n   1. Absolute neutrophil count ≥ 1000\u002FμL, (C-SOT) or ≥ 500\u002FμL (C-HCT), with or without cytokine support.\n   2. Platelet count ≥ 50,000\u002FμL, with or without transfusion or cytokine support. For C-HCT, platelet count \\\u003C 50,000\u002FμL but ≥ 20,000\u002FμL, with or without transfusion support, is permissible if the participant has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \\[CTCAE\\], version 5.0).\n   3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \\\u003C 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and\u002For PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction.\n10. Participant or participant's representative is willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Currently active Burkitt, T-cell, NK\u002FT-cell lymphoma\u002FLPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.\n2. Daily steroids of \\> 0.5 mg\u002Fkg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis.\n3. Untreated CNS PTLD or CNS PTLD for which the participant is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE: Participants with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.\n4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment.\n5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment.\n6. For C-HCT: active adenovirus viremia.\n7. Need for vasopressor or ventilatory support.\n8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment.\n9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only).\n10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception.\n11. Inability to comply with study-related procedures.\n12. Any medical condition or organ system dysfunction that in the investigator';s opinion, could compromise the participant's safety or ability to complete the study.",{"count":76,"type":21},115,[78],"PHASE3","The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.",[81,82,83,84,85],"Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)","Solid Organ Transplant Complications","Lymphoproliferative Disorders","Allogeneic Hematopoietic Cell Transplant","Stem Cell Transplant Complications",[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,84,104],"Epstein-Barr Virus (EBV)-associated Lymphoproliferative Disease (LPD)","Epstein-Barr Virus (EBV)","Cytotoxic T lymphocyte (CTL)","Cancer After Transplant","Kidney transplant","Renal transplant","Liver transplant","Heart transplant","Lung transplant","Intestinal transplant","Pancreas transplant","Post-transplant Lymphoma","Solid Organ Transplant (SOT)","Bone Marrow Transplant Complications","Epstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)","Hematopoietic Cell Transplant (HCT)","Hematopoietic Stem Cell Transplantation (HSCT)","Allogeneic, Off-The-Shelf T-cell Immunotherapy",{"date":34,"type":35},{"date":107,"type":35},"2017-12-29",{"date":109,"type":21},"2030-08",{"name":41,"class":42},71,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":22,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100567509","phase-1-fih-trial-of-vert-002-in-patients-with-locally-advanced-or-metastatic-solid-tumors-with-met-alterations-100567509","NCT06669117","FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations","A First-In-Human (FIH) Phase I\u002FII Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations","Inclusion Criteria:\n\n1. Part 1: histological confirmation of relapsed and\u002For refractory locally advanced or metastatic solid tumor for which no standard of care treatment is available.\n2. Part 2: histological confirmation of locally advanced or metastatic NSCLC Stage IIIB\u002FC or IV (American Joint Commission on Cancer \\[AJCC\\] 8th edition) in participants who are not eligible for or should have received available standard of care therapies including curative intent surgery, chemoradiation, radiotherapy or systemic therapy.\n3. Part 1: presence of at least one of the following MET alterations based on local documentation of blood or archived tissue results:\n\n   * METex14 mutation\n   * MET kinase domain activating gene mutations (e.g. H1094L\u002FR\u002FY, D1228H\u002FN\u002FV, Y1230A\u002FC\u002FD\u002FH)\n   * MET amplification\n4. Part 2-a: presence of METex14 mutation (based on local documentation of blood or archived tissue results) and for Part 2-b presence of at least one of the following MET alterations: METex14 mutation (based on local documentation of blood or archived tissue results), de novo MET amplification (based on local documentation of archived tissue results). Confirmation after enrollment in the trial will be performed by central testing from an archival tumor biopsy sample (either tissue block or at least 15 serial cut unstained slides of 5 μm, at least 20% tumor content). In case no archival biopsy is available for central testing, the patient must be willing to have a fresh tumor biopsy sample collected and the tumor biopsy should be deemed safe and feasible by the investigator.\n5. Part 2: at least one measurable target lesion according to RECIST v1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n7. Part 1: participants may have received MET Tyrosine Kinase Inhibitor (TKI) as part of previous treatment, regardless of the line of therapy (first or second line), and regardless of the MET TKI being combined or not. Note: crizotinib will be considered a MET TKI.\n8. Part 2: a maximum of 3 prior lines of systemic therapies.\n9. Adequate hematologic function.\n10. Adequate hepatic function.\n11. Adequate renal function.\n12. Albumin ≥ 3 g\u002FdL.\n13. Adequate coagulation function.\n14. Adequate cardiac function.\n15. Female participants of childbearing potential must have a negative highly sensitive serum β-HCG test performed within 7 days prior to the first dose of VERT-002 and a negative urine pregnancy test performed at C1D1 prior to the first dose of VERT-002.\n16. Male participants\u002Fpartners with female spouse\u002Fpartners of childbearing potential must agree to take appropriate precautions to avoid fathering a child.\n\nNOTE: Other protocol defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n1. Part 2: Documented evidence by local testing of targetable oncogene driver mutations.\n2. History of a primary malignancy other than the cancer under trial (as defined for Parts 1 and 2) with the exception of:\n\n   * Participants with a previous malignancy who completed their anticancer treatment at least 2 years before signing informed consent and with no evidence of residual disease from the prior malignancy at screening.\n   * Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate \\> 90%) that are adequately treated.\n3. Uncontrolled Central Nervous System (CNS) metastases or spinal cord compression that are associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease.\n4. History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical structure or from a similar class.\n5. Active, bacterial, fungal, or viral infection, within 2 weeks prior to the first dose of VERT-002 (C1D1).\n6. Positive SARs-CoV-2 or variants of SARs-CoV2 test within 2 weeks prior to first dose administration of VERT-002 (C1D1) or with suspected infection with SARs-CoV-2 or variants of SARs-CoV-2 and confirmation pending.\n7. Impaired cardiovascular function or clinically significant cardiovascular disease (either active or within 6 months prior to signing main informed consent).\n8. Uncontrolled intercurrent illness including, but not limited to psychiatric illness or social situation that would limit compliance with trial requirements.\n9. Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis that requires steroid treatment, or any evidence of clinically active ILD.\n10. Women who are pregnant or breastfeeding.\n11. Prior anticancer therapy:\n\n    * MET TKI within 7 days prior to the first dose of VERT-002,\n    * Any other systemic anticancer therapy within 28 days or 5 half-lives of the anticancer therapy whichever is the shortest, but with a minimum of 14 days interval, prior to the first dose of VERT-002 (C1D1),\n    * Radiotherapy to a large field or including a vital organ (including whole brain radiotherapy or stereotactic radiosurgery to brain) within 14 days prior to the first dose of VERT-002 (C1D1).\n12. Live attenuated vaccine within 28 days prior to the first dose of VERT-002 (C1D1).\n13. Any toxicities from prior therapy with NCI- CTCAE Grade \\> 1 at the time of the first dose administration of VERT-002 (C1D1). Exceptions include any grade alopecia, fatigue and peripheral neuropathy with a grade ≤ 2.\n14. Major surgical procedure within 14 days of the first dose of VERT-002 (C1D1).\n15. Participation in a clinical trial with administration of an investigational drug within 5 half- lives plus 14 days of the investigational drug, prior to the first dose of VERT-002 (C1D1).\n\nNOTE: Other protocol defined exclusion criteria may apply.",{"count":120,"type":21},140,[24,25],"The goal of this clinical trial is to investigate the safety, the activity of VERT-002 (PFL-002), and the optimal safe dose to be used, in participants with solid tumors including non-small cell lung cancer.",[124,125],"Solid Tumor","MET Alteration",[127,128,129],"Locally advanced or metastatic solid tumors","MET alteration","Non-small cell lung cancer","2025-06-29",{"date":132,"type":35},"2025-07-02",{"date":134,"type":35},"2024-10-22",{"date":136,"type":21},"2032-10-01",{"name":41,"class":42},19,{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100476984","treatment-patterns-of-neratinib-in-her2-ebc-in-china-100476984","NCT05491057","Treatment Patterns of Neratinib in HER2+ EBC in China","A Multicenter, Open-label, Single-arm, Non-interventional Study to Investigate the Treatment Patterns of Nerlynx® (Neratinib) in HER2-positive Early-stage Breast Cancer in China","Inclusion Criteria:\n\n* Signed written informed consent approved by the reviewing Ethics Committee (EC).\n* Adult patients (≥18 years of age, no upper limit).\n* Eligible to receive neratinib for extended adjuvant treatment as per prescribing information in China, diagnosed with HER2 overexpressing\u002Famplified early-stage breast cancer regardless of hormone receptor (HR) status and clinical\u002Fradiological assessed to be negative for recurrences or metastatic disease.\n\nExclusion Criteria:\n\n* Presence of any contraindication with regard to the neratinib treatment.\n* Current or upcoming participation in an interventional clinical trial. (Investigational treatment within four weeks of enrolment).",{"count":147,"type":21},500,"OBSERVATIONAL","This is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of Neratinib in HER2-positive early-stage breast cancer in China",[151],"Breast Cancer","NOT_YET_RECRUITING","2022-08-04",{"date":155,"type":35},"2022-08-08",{"date":157,"type":21},"2022-09-30",{"date":159,"type":21},"2026-06-30",{"name":41,"class":42},1,""]