[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05873686":3,"trial-entities:NCT05873686":249,"trial-summary:NCT05873686":265},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":24,"study_type":40,"primary_purpose":41,"phases":42,"enrollment_info":44,"interventions":47,"primary_outcomes":55,"secondary_outcomes":72,"sex":85,"minimum_age":86,"maximum_age":16,"healthy_volunteers":87,"eligibility_criteria":88,"std_ages":92,"locations":95,"central_contacts":226,"overall_officials":235,"references":243,"see_also_links":248},"NCT05873686","NXP900-101","A Phase 1 Clinical Study of NXP900 in Subjects With Advanced Cancers","RECRUITING","2027-07","2026-07","2026-07-09","2023-10-26","Nuvectis Pharma, Inc.","INDUSTRY",true,"This is a multi-center, first-in-human, open label, dose escalation (Part A) and expansion (Part B) Phase 1 study in subjects with advanced solid tumors and in subjects with solid tumors with selected genetic alterations that are either direct (YES1 amplification) or dependent (Hippo Pathway alterations) targets of NXP900.",null,[18,19,20,21,22,23],"Advanced Solid Tumor","NSCLC (Non-small Cell Lung Cancer)","Renal Cancer","Mesothelioma","Non-Small Cell Squamous Lung Cancer","Non-small Cell Lung Adenocarcinoma",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Solid Tumor","Carcinoma","Neoplasms","Adenocarcinoma","YES1","YAP1","TAZ1","NF2","FAT1","LATS1","TYMS","gene amplification","gene mutation","IDH1","IDH2","INTERVENTIONAL","TREATMENT",[43],"PHASE1",{"count":45,"type":46},140,"ESTIMATED",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52},"DRUG","NXP900","NXP900 is an orally administered SRC\u002FYES1 kinase inhibitor",[53,54],"Dose Escalation (Part A)","Dose Expansion (Part B)",[56,59,62,66,69],{"measure":57,"timeFrame":58},"Number of patients with treatment related adverse events and\u002For clinical laboratory abnormalities","Up to 30 days post treatment",{"measure":60,"timeFrame":61},"Part A: Number of patients who experience Dose Limiting Toxicities (DLT) as defined in the protocol","Day 28",{"measure":63,"description":64,"timeFrame":65},"Part B: Objective response rate (ORR)","Best response of complete response (CR) or partial response (PR) per RECIST 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).","Up to 24 months",{"measure":67,"description":68,"timeFrame":65},"Part B: Duration of Response (DoR)","Confirmed CR or PR from the first documented response to the date of documented disease progression or death.",{"measure":70,"description":71,"timeFrame":65},"Part B: Disease Control Rate (DCR)","The proportion of patients with stable disease (SD), partial response (PR), or complete response (CR).",[73,75,77,79,81,83],{"measure":74,"timeFrame":65},"Area under the concentration-time curve (AUC) of NXP900",{"measure":76,"timeFrame":65},"Maximum observed concentration (Cmax) of NXP900",{"measure":78,"timeFrame":65},"Time to peak concentration (Tmax) of NXP900",{"measure":80,"timeFrame":65},"Half-life (T1\u002F2) of NXP900",{"measure":82,"timeFrame":65},"Apparent volume of distribution at steady state (Vss\u002FF) of NXP900",{"measure":84,"timeFrame":65},"Apparent plasma clearance at steady state (Clss\u002FF) of NXP900","ALL","18 Years",false,{"inclusion":89,"exclusion":90,"raw_text":91},[],[],"Part A\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors for whom there is no authorized or effective therapy available, or for whom such therapies are considered inappropriate by the Investigator.\n4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with known human epidermal growth factor receptor 2 (HER2+) overexpressing malignancies.\n2. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days, (42 days for nitrosoureas, mitomycin-C) of first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n3. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n4. Subjects with treated brain metastases with evidence of progression within 28 days after central nervous system (CNS)-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging \\[MRI\\] or computed tomography \\[CT\\] scan) during the Screening period.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.\n\nPart B:\n\nInclusion Criteria:\n\n1. Provide written informed consent.\n2. 18 years old or older.\n3. Advanced, metastatic, and\u002For progressive solid tumors with pathogenic molecular alterations:\n\n   1. Non-small cell lung cancer (adenocarcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   2. Non-small cell lung cancer (squamous cell carcinoma); YES1, TYMS amplification or FAT1 pathogenic mutation\n   3. Renal cancer; NF2 pathogenic mutation\n   4. Mesothelioma; NF2 pathogenic mutation\n   5. Other solid tumors with a NF2, FAT1 or LATS1 pathogenic gene mutation or TYMS, YAP1, YES1, or TAZ1 gene amplification, or cholangiocarcinoma with IDH1 or IDH2 mutations.\n4. Must have received 1-3 prior therapies appropriate for their tumor type and stage of disease\n5. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (or mRECIST 1.1 for subjects with pleural mesothelioma).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n\nExclusion Criteria:\n\n1. Subjects with the following combination of cancer type and pathogenic molecular alterations are excluded:\n\n   1. Subjects with colorectal cancer, glioma, melanoma, or anaplastic thyroid conditions with BRAF mutations.\n   2. Subjects with NSCLC with BRAF or EGFR mutations or HER2 overexpression.\n   3. Subjects with breast cancer, gastric cancer, esophageal junction adenocarcinoma or biliary cancer with HER2 alterations,\n2. Subjects with anal, penile, cervical or head and neck cancers with a prior history of human papilloma virus (HPV) infection.\n3. Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, or investigational agent within 28 days (42 days for nitrosoureas, mitomycin-C) prior to first dose of NXP900. Subjects can continue to receive bisphosphonates due to metastatic bone disease or GnRH agonists if they have prostate cancer.\n4. Ongoing toxic manifestations of previous treatments \\> Grade 2 with the exception of alopecia and neuropathy.\n5. Female subjects who can become pregnant (or are already pregnant or lactating), unless they have a negative serum pregnancy test before enrollment and agree to use at least one highly effective form of contraception .\n6. Male subjects with partners of childbearing potential, unless they agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide).\n7. Major surgery from which the subject has not yet recovered.",[93,94],"ADULT","OLDER_ADULT",[96,109,117,128,137,145,153,160,168,179,191,195,202,210,219],{"facility":97,"status":7,"city":98,"state":99,"zip":100,"country":101,"contacts":102,"geoPoint":106},"Mayo Clinic","Phoenix","Arizona","85054","United States",[103],{"role":104,"phone":105},"CONTACT","855-776-0015",{"lat":107,"lon":108},33.44838,-112.07404,{"facility":110,"status":7,"city":111,"state":112,"zip":113,"country":101,"geoPoint":114},"UC San Diego Moores Cancer Center","La Jolla","California","92093",{"lat":115,"lon":116},32.84727,-117.2742,{"facility":118,"status":7,"city":119,"state":120,"zip":121,"country":101,"contacts":122,"geoPoint":125},"Sarah Cannon Research Institute at HealthONE","Denver","Colorado","80218",[123],{"role":104,"phone":124},"720 754-2610",{"lat":126,"lon":127},39.73915,-104.9847,{"facility":97,"status":7,"city":129,"state":130,"zip":131,"country":101,"contacts":132,"geoPoint":134},"Jacksonville","Florida","32224",[133],{"role":104,"phone":105},{"lat":135,"lon":136},30.33218,-81.65565,{"facility":138,"status":7,"city":139,"state":140,"zip":141,"country":101,"geoPoint":142},"University of Chicago","Chicago","Illinois","60637",{"lat":143,"lon":144},41.85003,-87.65005,{"facility":146,"status":7,"city":147,"state":148,"zip":149,"country":101,"geoPoint":150},"Mayo Clinic Rochester","Rochester","Minnesota","55905",{"lat":151,"lon":152},44.02163,-92.4699,{"facility":154,"status":7,"city":155,"state":155,"zip":156,"country":101,"geoPoint":157},"Memorial Sloan Kettering Cancer Center","New York","10021",{"lat":158,"lon":159},40.71427,-74.00597,{"facility":161,"status":7,"city":162,"state":163,"zip":164,"country":101,"geoPoint":165},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":166,"lon":167},41.4995,-81.69541,{"facility":169,"status":7,"city":170,"state":171,"zip":172,"country":101,"contacts":173,"geoPoint":176},"Oregon Health and Science University","Portland","Oregon","97239",[174],{"role":104,"phone":175},"503-494-6865",{"lat":177,"lon":178},45.52345,-122.67621,{"facility":180,"status":7,"city":181,"state":182,"zip":183,"country":101,"contacts":184,"geoPoint":188},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",[185],{"name":186,"role":104,"phone":187},"Jordi Rodon Ahnert, MD, PhD","713 792-5603",{"lat":189,"lon":190},29.76328,-95.36327,{"facility":192,"status":7,"city":181,"state":182,"zip":193,"country":101,"geoPoint":194},"NEXT Oncology Houston","77054",{"lat":189,"lon":190},{"facility":196,"status":7,"city":197,"state":182,"zip":198,"country":101,"geoPoint":199},"NEXT Oncology Dallas","Irving","75039",{"lat":200,"lon":201},32.81402,-96.94889,{"facility":203,"status":7,"city":204,"state":205,"zip":206,"country":101,"geoPoint":207},"NEXT Oncology Virginia","Fairfax","Virginia","22031",{"lat":208,"lon":209},38.84622,-77.30637,{"facility":211,"status":212,"city":213,"zip":214,"country":215,"geoPoint":216},"Western General Hospital - NHS Lothian","COMPLETED","Edinburgh","EH4 2XU","United Kingdom",{"lat":217,"lon":218},55.95206,-3.19648,{"facility":220,"status":212,"city":221,"zip":222,"country":215,"geoPoint":223},"The Royal Marsden NHS Foundation and Trust","London","SW3 6JJ",{"lat":224,"lon":225},51.50853,-0.12574,[227,231],{"name":228,"role":104,"phone":229,"email":230},"Erin Belshaw","(201) 627-8129","ebelshaw@nuvectis.com",{"name":232,"role":104,"phone":233,"email":234},"Shay Shemesh","(201) 614-3153","sshemesh@nuvectis.com",[236,240],{"name":237,"affiliation":238,"role":239},"Udai Banerji, Prof","Institute of Cancer Research, Royal Marsden NHS Foundation Trust","PRINCIPAL_INVESTIGATOR",{"name":241,"affiliation":242,"role":239},"Gerald Falchook, MD","Sarah Cannon Cancer Institute, HealthOne Denver",[244],{"pmid":245,"type":246,"citation":247},"39089584","DERIVED","Dash S, Hanson S, King B, Nyswaner K, Foss K, Tesi N, Harvey MJB, Navarro-Marchal SA, Woods A, Poradosu E, Unciti-Broceta A, Carragher NO, Brognard J. The SRC family kinase inhibitor NXP900 demonstrates potent antitumor activity in squamous cell carcinomas. J Biol Chem. 2024 Sep;300(9):107615. doi: 10.1016\u002Fj.jbc.2024.107615. Epub 2024 Jul 31.",[],{"nct_id":4,"conditions":250,"biomarkers":255},[251,252,253,254],"Kidney Carcinoma","Lung Non-Small Cell Carcinoma","Mesothelial Neoplasm","Solid Neoplasm",[256,257,258,259,260,261,262,263,264],"FAT1 Gene","IDH1 Gene","IDH2 Gene","NF2 Gene","Serine\u002FThreonine-Protein Kinase LATS1","TAFAZZIN wt Allele","Transcriptional Coactivator YAP1","TYMS Gene","YES1 Gene",{"nct_id":4,"found":14,"summary":266,"prompt_version":276},{"design":267,"status":268,"heading":269,"summary":270,"follow_up":271,"word_count":272,"commitments":273,"compensation":274,"drugs_mentioned":275},"This is a Phase 1, multi-center study that is open-label, meaning both you and your doctors will know you are receiving NXP900. It plans to enroll 140 participants and has two parts: a dose escalation part (Part A) and an expansion part (Part B).","completed","Phase 1 Study of NXP900 for Advanced Cancers","This study is testing a new oral drug called NXP900 for people with advanced solid tumors, including non-small cell lung cancer, renal cancer, and mesothelioma. NXP900 works by blocking certain proteins called SRC\u002FYES1 kinase. The main goals are to see how safe NXP900 is and what side effects it might cause, especially in the first month. Researchers will also look at how many patients respond to the treatment over two years. You might be able to join if you are 18 or older, have advanced cancer with no other effective treatments, and your cancer can be measured. This is a first-in-human study, meaning it's the first time NXP900 is being tested in people.","Researchers will monitor for side effects for up to 30 days after treatment. They will also track how well the treatment works for up to 24 months.",113,"Not specified in the trial record.","Not stated in the trial record.",[50],"v2"]