[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Inhibrx Biosciences, Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":111},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,79],{"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":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100377763","phase-1-study-of-inbrx-106-and-inbrx-106-in-combination-with-pembrolizumab-keytruda-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-hexavalent-ox40-agonist-100377763",false,"NCT04198766","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","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.","ALL","18 Years",{"count":19,"type":20},340,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","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.",[27,28,29,30,31,32,33,34],"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",[36,37,38,29,39,28,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65],"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","RECRUITING","2026-07-28",{"date":69,"type":70},"2026-07-29","ACTUAL",{"date":72,"type":70},"2019-12-10",{"date":74,"type":20},"2033-07",{"name":76,"class":77},"Inhibrx Biosciences, Inc","INDUSTRY",42,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":90,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100340699","phase-1-phase-1-study-of-inbrx-109-in-subjects-with-locally-advanced-or-metastatic-solid-tumors-including-sarcomas-100340699","NCT03715933","Phase 1 Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas","Inclusion Criteria:\n\n1. Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.\n2. Part 3 combination therapy expansion tumor types:\n\n   * Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.\n   * Colorectal adenocarcinoma: Patients who have failed 1 (one) prior line of systemic therapy that did not include irinotecan.\n   * Colorectal adenocarcinoma: Patients who have failed 2 but no more than 3 prior lines of systemic therapy and are FTD\u002FTPI-naïve.\n3. Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.\n4. Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).\n6. Estimated life expectancy of at least 12 weeks.\n7. Availability of archival tissue or fresh cancer biopsy are mandatory.\n\nExclusion Criteria:\n\n1. Prior treatment with or exposure to DR5 agonists.\n2. Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.\n3. Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.\n4. Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.\n5. Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.\n6. Prior or concurrent malignancies. Exceptions per protocol.\n7. Hematologic malignancies.\n8. Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.\n9. Chronic liver diseases including fatty liver. Exception: Patients \\\u003C 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion\u002Fexclusion criteria is confirmed.\n10. Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.\n11. Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.\n12. Known sensitivity or contraindications to the following drugs:\n\n    * Ewing sarcoma: irinotecan or TMZ\n    * colorectal adenocarcinoma: FU, leucovorin, irinotecan, bevacizumab or FTP\u002FTPI\n13. Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.\n14. Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.\n15. Major surgery within 4 weeks prior to enrollment on this trial.\n16. Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.\n17. Other exclusion criteria per protocol.","12 Years","85 Years",{"count":89,"type":20},411,[23],"This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).",[93,94],"Ewing Sarcoma","Colorectal Adenocarcinoma",[96,97,38,98,99,93,100,101],"Phase 1","Phase 1 Clinical Trial","Sarcoma","DR5","CRC","colorectal adenocarcinoma","2026-05-20",{"date":104,"type":70},"2026-05-22",{"date":106,"type":70},"2018-10-08",{"date":108,"type":20},"2029-06",{"name":76,"class":77},36,""]