[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04198766":3,"trial-entities:NCT04198766":578,"trial-summary:NCT04198766":588},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":27,"study_type":58,"primary_purpose":59,"phases":60,"enrollment_info":63,"interventions":66,"primary_outcomes":128,"secondary_outcomes":146,"sex":162,"minimum_age":163,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":164,"std_ages":192,"locations":195,"central_contacts":563,"overall_officials":568,"references":572,"see_also_links":577},"NCT04198766","Ph 1 Ph 2 INBRX-106","Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)","An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1\u002F2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors","RECRUITING","2033-07","2026-07","2026-07-29","2019-12-10","Inhibrx Biosciences, Inc","INDUSTRY",false,"This is a Phase 1\u002F2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \\& Dohme LLC, a subsidiary of Merck \\& Co., Inc., Rahway, NJ, USA.",null,[19,20,21,22,23,24,25,26],"Solid Tumor","Non-Small Cell Lung Cancer","Head and Neck Cancer","Melanoma","Gastric Cancer","Renal Cell Carcinoma","Urothelial Carcinoma","Resectable Non-Small-Cell Lung Cancer",[28,29,30,21,31,20,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57],"Phase 1 and Phase 2","Phase 1 and Phase 2 Clinical Trial","Solid Tumors","Lung Cancer","OX40 receptor agonist","PD-L1 positive","Pembrolizumab","Keytruda","Chemotherapy","Immunotherapy","HNSCC","Oropharyngeal cancer","Hypopharyngeal cancer","Oral cancer","INBRX-106","Neoplasms, Glandular and Epithelial","Neoplasms by Histologic Type","Neoplasms","Neoplasms, Squamous Cell","Head and Neck Neoplasms","Neoplasms by Site","Carcinoma","Carcinoma, Squamous Cell","Molecular Mechanisms of Pharmacological Action","Antineoplastic Agents, Immunological","Antineoplastic Agents","Squamous Cell Carcinoma of Head and Neck","NSCLC","Neoadjuvant","Adjuvant","INTERVENTIONAL","TREATMENT",[61,62],"PHASE1","PHASE2",{"count":64,"type":65},340,"ESTIMATED",[67,86,93,98,102,106,112,116,120,124],{"type":68,"name":69,"description":70,"armGroupLabels":71},"DRUG","INBRX-106 - Hexavalent OX40 agonist antibody","The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).",[72,73,74,75,76,77,78,79,80,81,82,83,84,85],"Part 1 INBRX-106 Escalation (Not Recruiting)","Part 2 (Cohorts C1\u002FC2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)","Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)","Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)","Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)","Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting)","Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting)","Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting)","Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI\u002FTMB-high\u002FMMRd tumors Not Recuriting","Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)","Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC","Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC","Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC","Part 4(Cohort F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC",{"type":68,"name":87,"description":88,"armGroupLabels":89,"otherNames":91},"pembrolizumab 200 mg","pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.",[90,73,74,76,79,80,81,82,83,84,85],"Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting)",[92],"KEYTRUDA",{"type":68,"name":94,"description":95,"armGroupLabels":96,"otherNames":97},"pembrolizumab 400 mg","pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)",[75,76],[92],{"type":68,"name":99,"description":100,"armGroupLabels":101},"Carboplatin AUC-5","carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.",[81,85],{"type":68,"name":103,"description":104,"armGroupLabels":105},"Carboplatin AUC-6","carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[83],{"type":68,"name":107,"description":108,"armGroupLabels":109,"otherNames":110},"Pemetrexed 500 mg\u002Fm2","pemetrexed 500 mg\u002Fm2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles. In Cohort F8, pemetrexed 500 mg\u002Fm2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.",[81,82,85],[111],"Alimta®",{"type":68,"name":113,"description":114,"armGroupLabels":115},"Cisplatin 75mg\u002Fm2","cisplatin 75mg\u002Fm2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[82,85],{"type":68,"name":117,"description":118,"armGroupLabels":119},"Paclitaxel 200mg\u002Fm2","paclitaxel 200mg\u002Fm2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4",[83],{"type":68,"name":121,"description":122,"armGroupLabels":123},"Nab paclitaxel 100mg\u002Fm2","Nab paclitaxel 100mg\u002Fm2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4",[83],{"type":68,"name":125,"description":126,"armGroupLabels":127},"Gemcitabine (1000 mg\u002Fm2)","Gemcitabine 1000 mg\u002Fm2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4",[85],[129,133,135,138,141,143],{"measure":130,"description":131,"timeFrame":132},"Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab","Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0","~2 years",{"measure":134,"description":131,"timeFrame":132},"Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab",{"measure":136,"description":137,"timeFrame":132},"MTD and\u002For RP2D of INBRX-106 as single agent and in combination with pembrolizumab","Maximum Tolerated Dose (MTD) and\u002For Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab",{"measure":139,"description":140,"timeFrame":132},"Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts","The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1",{"measure":142,"description":131,"timeFrame":132},"Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC",{"measure":144,"description":145,"timeFrame":132},"To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant\u002Fadjuvant therapy in adult subjects with NSCLC. (Cohort F8)","Major pathological response (mPR) and pathological complete response (cPR) criteria.",[147,150,153,156,159],{"measure":148,"description":149,"timeFrame":132},"Area under the serum concentration time curve (AUC) of INBRX-106","Area under the serum concentration time curve (AUC) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.",{"measure":151,"description":152,"timeFrame":132},"Maximum observed serum concentration (Cmax) of INBRX-106","Maximum observed serum concentration (Cmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.",{"measure":154,"description":155,"timeFrame":132},"Trough observed serum concentration (Ctrough) of INBRX-106","Trough observed serum concentration (Ctrough) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.",{"measure":157,"description":158,"timeFrame":132},"Time to Cmax (Tmax) of INBRX-106","Time to Cmax (Tmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.",{"measure":160,"description":161,"timeFrame":132},"Immunogenicity of INBRX-106","Frequency of anti-drug antibodies (ADA) against INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.","ALL","18 Years",{"inclusion":165,"exclusion":176,"raw_text":191},[166,167,168,169,170,171,172,173,174,175],"Males or females aged ≥18 years.","Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.","Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G\u002FGEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.","Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G\u002FGEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.","For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1\u002FL1 regimen.","For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1\u002FL1 in curative (neo-adjuvant\u002Fadjuvant) setting is allowed only if completed \\>\u002F= 6 months prior to progression to local recurrence or metastatic disease.","For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.","All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.","PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.","Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.",[177,178,179,180,181,182,183,184,185,186,187,188,189,190],"Prior exposure to OX40 agonists. Exposure to anti-PD-1 and\u002For anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.","Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.","Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)","Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.","Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.","Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.","Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.","History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.","Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.","Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\\u003C92% on room air.","Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.","Major surgery within 4 weeks prior to enrollment on this trial.","Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.","Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.","Select Inclusion Criteria:\n\n* Males or females aged ≥18 years.\n* Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.\n* Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G\u002FGEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.\n* Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G\u002FGEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.\n* For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1\u002FL1 regimen.\n* For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1\u002FL1 in curative (neo-adjuvant\u002Fadjuvant) setting is allowed only if completed \\>\u002F= 6 months prior to progression to local recurrence or metastatic disease.\n* For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery.\n* All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.\n* PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). For Cohort F8, any TPS (including 0%) is acceptable.\n* Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.\n\nSelect Exclusion Criteria:\n\n* Prior exposure to OX40 agonists. Exposure to anti-PD-1 and\u002For anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways.\n* Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.\n* Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)\n* Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.\n* Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.\n* Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.\n* Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.\n* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.\n* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.\n* Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \\\u003C 3 months prior to enrollment on this trial; left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \\\u003C92% on room air.\n* Active, hemodynamically significant pulmonary embolism within 12 weeks prior to enrollment on this trial.\n* Major surgery within 4 weeks prior to enrollment on this trial.\n* Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.\n* Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.\n* Additional in- and exclusion criteria per protocol.",[193,194],"ADULT","OLDER_ADULT",[196,214,227,240,250,261,276,290,301,316,325,333,349,358,369,376,384,391,399,414,422,430,438,446,454,461,468,475,488,496,504,510,513,516,523,529,532,535,542,548,551,557],{"facility":197,"status":8,"city":198,"state":199,"zip":200,"country":201,"contacts":202,"geoPoint":211},"City of Hope","Duarte","California","91010","United States",[203,208],{"name":204,"role":205,"phone":206,"email":207},"New Patient Services","CONTACT","800-826-4673","shhussain@coh.org",{"name":209,"role":210},"Aditya Shreenivas, MD","PRINCIPAL_INVESTIGATOR",{"lat":212,"lon":213},34.13945,-117.97729,{"facility":215,"status":8,"city":216,"state":199,"zip":217,"country":201,"contacts":218,"geoPoint":224},"Los Angeles Cancer Network","Glendale","91204",[219,222],{"name":220,"role":205,"email":221},"Elizabeth Brown","Elizabeth.Brown@lahomg.com",{"name":223,"role":210},"Sungwon Kyung, MD",{"lat":225,"lon":226},34.14251,-118.25508,{"facility":228,"status":8,"city":229,"state":199,"zip":230,"country":201,"contacts":231,"geoPoint":237},"California Research Institute","Los Angeles","90027",[232,235],{"name":233,"role":205,"email":234},"Swati Shrestha","sw@caresinst.com",{"name":236,"role":210},"Ghassan Al-Jazayrly, MD",{"lat":238,"lon":239},34.05223,-118.24368,{"facility":241,"status":8,"city":229,"state":199,"zip":242,"country":201,"contacts":243,"geoPoint":249},"Valkyrie Clinical Trials","90069",[244,247],{"name":245,"role":205,"email":246},"Myo Zaw","myo.zaw@valkyrieclinicaltrials.com",{"name":248,"role":210},"David Berz, MD",{"lat":238,"lon":239},{"facility":241,"status":8,"city":251,"state":199,"zip":252,"country":201,"contacts":253,"geoPoint":258},"Murrieta","92562",[254,257],{"name":255,"role":205,"email":256},"Isabella Gudino","Isabella.gudino@vctcare.com",{"name":248,"role":210},{"lat":259,"lon":260},33.55391,-117.21392,{"facility":262,"status":8,"city":263,"state":199,"zip":264,"country":201,"contacts":265,"geoPoint":273},"Providence Medical Foundation","Santa Rosa","95403",[266,271],{"name":267,"role":205,"phone":268,"phoneExt":269,"email":270},"Clinical Research Coordinator","707-521-3810","1181","jackson.barnard@providence.org",{"name":272,"role":210},"Ian Anderson, MD",{"lat":274,"lon":275},38.44047,-122.71443,{"facility":277,"status":8,"city":278,"state":279,"zip":280,"country":201,"contacts":281,"geoPoint":287},"Clermont Oncology Center","Clermont","Florida","34711",[282,285],{"name":283,"role":205,"email":284},"Kiran Penta","kiran@aorcorp.com",{"name":286,"role":210},"Gopal Kunta, MD",{"lat":288,"lon":289},28.54944,-81.77285,{"facility":291,"status":8,"city":292,"state":279,"zip":293,"country":201,"contacts":294,"geoPoint":298},"Mid Florida Hematology and Oncology Center","Orange City","32763",[295,296],{"name":283,"role":205,"email":284},{"name":297,"role":210},"Santosh Nair, MD",{"lat":299,"lon":300},28.94888,-81.29867,{"facility":302,"status":8,"city":303,"state":304,"zip":305,"country":201,"contacts":306,"geoPoint":313},"Winship Cancer Institute - Emory University","Atlanta","Georgia","30322",[307,311],{"name":308,"role":205,"phone":309,"email":310},"Kimberly Homere","404-778-6583","kimberly.homere@emory.edu",{"name":312,"role":210},"Conor Steuer, MD",{"lat":314,"lon":315},33.749,-84.38798,{"facility":317,"status":318,"city":319,"state":320,"zip":321,"country":201,"geoPoint":322},"The University of Chicago Medical Center","ACTIVE_NOT_RECRUITING","Chicago","Illinois","60637",{"lat":323,"lon":324},41.85003,-87.65005,{"facility":326,"status":318,"city":327,"state":328,"zip":329,"country":201,"geoPoint":330},"University of Iowa","Iowa City","Iowa","52242",{"lat":331,"lon":332},41.66113,-91.53017,{"facility":334,"status":8,"city":335,"state":336,"zip":337,"country":201,"contacts":338,"geoPoint":346},"Norton Cancer Institute","Louisville","Kentucky","40202",[339,344],{"name":340,"role":205,"phone":341,"phoneExt":342,"email":343},"Jenn Broadway, RN","502-629-2500","19535","Jennifer.Broadway@nortonhealthcare.org",{"name":345,"role":210},"John Hamm, MD",{"lat":347,"lon":348},38.25424,-85.75941,{"facility":350,"status":351,"city":352,"state":353,"zip":354,"country":201,"geoPoint":355},"Barbara Ann Karmanos Cancer Institute","COMPLETED","Detroit","Michigan","48201",{"lat":356,"lon":357},42.33143,-83.04575,{"facility":359,"status":8,"city":352,"state":353,"zip":360,"country":201,"contacts":361,"geoPoint":368},"Henry Ford Cancer Institute","48202",[362,366],{"name":363,"role":205,"phone":364,"email":365},"Mahmoud Hossami","313-725-7842","mhossam1@hfhs.org",{"name":367,"role":210},"Amy Weise, MD",{"lat":356,"lon":357},{"facility":370,"status":318,"city":371,"state":353,"zip":372,"country":201,"geoPoint":373},"START Midwest","Grand Rapids","49546",{"lat":374,"lon":375},42.96336,-85.66809,{"facility":377,"status":318,"city":378,"state":379,"zip":380,"country":201,"geoPoint":381},"HealthPartners Cancer Research Center","Saint Louis Park","Minnesota","55426",{"lat":382,"lon":383},44.9483,-93.34801,{"facility":385,"status":351,"city":386,"state":379,"zip":387,"country":201,"geoPoint":388},"HealthPartners Cancer Research Center (Regions Hospital)","Saint Paul","55101",{"lat":389,"lon":390},44.94441,-93.09327,{"facility":392,"status":351,"city":393,"state":394,"zip":395,"country":201,"geoPoint":396},"Intermountain Health Cancer Centers of Montana","Billings","Montana","59102",{"lat":397,"lon":398},45.78329,-108.50069,{"facility":400,"status":8,"city":401,"state":402,"zip":403,"country":201,"contacts":404,"geoPoint":411},"Nebraska Cancer Specialists","Omaha","Nebraska","68130",[405,409],{"name":406,"role":205,"phone":407,"email":408},"Lindsey Becker","402-691-5255","lbecker@nebraskacancer.com",{"name":410,"role":210},"Ralph Hauke, MD",{"lat":412,"lon":413},41.25626,-95.94043,{"facility":415,"status":318,"city":416,"state":417,"zip":418,"country":201,"geoPoint":419},"Montefiore Medical Center","The Bronx","New York","10467",{"lat":420,"lon":421},40.84985,-73.86641,{"facility":423,"status":318,"city":424,"state":425,"zip":426,"country":201,"geoPoint":427},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":428,"lon":429},41.4995,-81.69541,{"facility":431,"status":318,"city":432,"state":433,"zip":434,"country":201,"geoPoint":435},"Providence Portland Medical Center","Portland","Oregon","97213",{"lat":436,"lon":437},45.52345,-122.67621,{"facility":439,"status":318,"city":440,"state":441,"zip":442,"country":201,"geoPoint":443},"Vanderbilt University School of Medicine","Nashville","Tennessee","37204",{"lat":444,"lon":445},36.16589,-86.78444,{"facility":447,"status":351,"city":448,"state":449,"zip":450,"country":201,"geoPoint":451},"Sarah Cannon Research Institute at Mary Crowley","Dallas","Texas","75230",{"lat":452,"lon":453},32.78306,-96.80667,{"facility":455,"status":351,"city":456,"state":449,"zip":457,"country":201,"geoPoint":458},"Renovatio Clinical - El Paso","El Paso","79915",{"lat":459,"lon":460},31.75872,-106.48693,{"facility":462,"status":351,"city":463,"state":449,"zip":464,"country":201,"geoPoint":465},"NEXT Oncology","San Antonio","78229",{"lat":466,"lon":467},29.42412,-98.49363,{"facility":469,"status":351,"city":470,"state":449,"zip":471,"country":201,"geoPoint":472},"Renovatio Clinical","The Woodlands","77380",{"lat":473,"lon":474},30.15799,-95.48938,{"facility":476,"status":8,"city":477,"state":449,"zip":478,"country":201,"contacts":479,"geoPoint":485},"The University of Texas Health Science Center at Tyler","Tyler","75701",[480,483],{"name":481,"role":205,"email":482},"Chaney Story","Chaney.Story@uttyler.edu",{"name":484,"role":210},"Erminia Massarelli, MD, PhD, MS",{"lat":486,"lon":487},32.35126,-95.30106,{"facility":489,"status":351,"city":490,"state":491,"zip":492,"country":201,"geoPoint":493},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"lat":494,"lon":495},38.84622,-77.30637,{"facility":497,"status":318,"city":498,"state":499,"zip":500,"country":201,"geoPoint":501},"Froedtert Hospital and the Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"lat":502,"lon":503},43.0389,-87.90647,{"facility":505,"status":351,"city":506,"country":506,"geoPoint":507},"Curie Oncology","Singapore",{"lat":508,"lon":509},1.28967,103.85007,{"facility":511,"status":351,"city":506,"country":506,"geoPoint":512},"Icon Cancer Centre Farrer Park",{"lat":508,"lon":509},{"facility":514,"status":351,"city":506,"country":506,"geoPoint":515},"Icon Cancer Centre Mount Alvernia",{"lat":508,"lon":509},{"facility":517,"status":318,"city":518,"country":519,"geoPoint":520},"The Catholic University of Korea, St. Vincent's Hospital","Gyeonggi-do","South Korea",{"lat":521,"lon":522},37.58944,126.76917,{"facility":524,"status":318,"city":525,"country":519,"geoPoint":526},"Asan Medical Center","Seoul",{"lat":527,"lon":528},37.566,126.9784,{"facility":530,"status":318,"city":525,"country":519,"geoPoint":531},"Severance Hospital, Yonsei University Health System",{"lat":527,"lon":528},{"facility":533,"status":318,"city":525,"country":519,"geoPoint":534},"The Catholic University of Korea Seoul St. Mary's Hospital,",{"lat":527,"lon":528},{"facility":536,"status":318,"city":537,"country":538,"geoPoint":539},"Changhua Christian Hospital (CCH)","Changhua","Taiwan",{"lat":540,"lon":541},24.0692,120.5512,{"facility":543,"status":318,"city":544,"country":538,"geoPoint":545},"E-Da Cancer Hospital","Kaohsiung City",{"lat":546,"lon":547},22.61626,120.31333,{"facility":549,"status":318,"city":544,"country":538,"geoPoint":550},"Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)",{"lat":546,"lon":547},{"facility":552,"status":318,"city":553,"country":538,"geoPoint":554},"National Cheng Kung University Hospital","Tainan",{"lat":555,"lon":556},22.99083,120.21333,{"facility":558,"status":351,"city":559,"country":538,"geoPoint":560},"Taipei Veterans General Hospital","Taipei",{"lat":561,"lon":562},25.05306,121.52639,[564],{"name":565,"role":205,"phone":566,"email":567},"Study Director - Inhibrx Biosciences, Inc","858-500-7833","clinicaltrials@inhibrx.com",[569],{"name":570,"affiliation":13,"role":571},"Clinical Lead","STUDY_DIRECTOR",[573],{"pmid":574,"type":575,"citation":576},"40404202","DERIVED","Holay N, Yadav R, Ahn SJ, Kasiewicz MJ, Polovina A, Rolig AS, Staebler T, Becklund B, Simons ND, Koguchi Y, Eckelman BP, de Durana YD, Redmond WL. INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. J Immunother Cancer. 2025 May 21;13(5):e011524. doi: 10.1136\u002Fjitc-2025-011524.",[],{"nct_id":4,"conditions":579,"biomarkers":584},[580,581,582,22,24,583,25],"Gastric Carcinoma","Lung Non-Small Cell Carcinoma","Malignant Head and Neck Neoplasm","Solid Neoplasm",[585,586,587],"MRC1 wt Allele","MSI1 Gene","TPM2 wt Allele",{"nct_id":4,"found":589,"summary":590,"prompt_version":600},true,{"design":591,"status":592,"heading":593,"summary":594,"follow_up":595,"word_count":596,"commitments":597,"compensation":598,"drugs_mentioned":599},"This is a Phase 1\u002F2, open-label (meaning you and your doctors will know which treatment you are receiving), non-randomized study with 340 planned participants.","completed","Study of INBRX-106 with or without Pembrolizumab for Advanced Solid Tumors","This study is testing INBRX-106, alone or combined with pembrolizumab (Keytruda®), for people with locally advanced or metastatic solid tumors, including non-small cell lung cancer, head and neck cancer, melanoma, and gastric cancer. You might be eligible if your disease has progressed despite standard treatments or if no other standard options are available. The main goals are to understand the safety of INBRX-106 and to find the best dose to use in future studies. Researchers will be looking at how often side effects occur and how severe they are over about two years. This study aims to find the safest and most effective dose of these treatments.","The frequency and severity of adverse events will be measured for approximately two years.",107,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]