[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ImmuneOncia Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100460490","phase-1-a-study-of-imc-002-in-patients-with-advanced-cancer-failed-to-standard-therapy-100460490",false,"NCT05276310","A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy","An Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy","Inclusion Criteria:\n\n1. Signed ICF\n2. Adult (19 years or older)\n3. Diagnosis and prior therapies\n\n   3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors\n\n   3-2. Part 2, HCC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)\n   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.\n   3. Child Pugh classification A\n\n   3-3. Part 2, TNBC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of triple negative breast cancer: negative of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2)\n   2. Received ≥1 prior systemic regimen and eligible for paclitaxel or gemcitabine\u002Fcarboplatin. Patients who have previously received the planned SOC in this study (paclitaxel or gemcitabine\u002Fcarboplatin) cannot be enrolled. If at least 6 months have elapsed since the completion of a prior SOC (paclitaxel, gemcitabine, and\u002For carboplatin) and the patient showed a tumor response to that regimen, the same SOC can be used in this trial.\n   3. Bisphosphonate or denosumab for bone metastases is allowed if started before Cycle 1 Day 1. Prophylactic use of bisphosphonates or denosumab in patients without bone diseases is not permitted, except for the treatment of osteoporosis.\n\n   3-4. Part 2, BTC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)\n   2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib\n\n   3-5. Part 2, B-cell lymphoma Cohort:\n   1. Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:\n\n      * diffuse large B-cell lymphoma (de novo or transformed)\n      * Mantle cell lymphoma\n      * Follicular lymphoma\n      * Marginal zone lymphoma (nodal, extranodal or mucosa associated)\n   2. Received ≥2 prior systemic therapies and eligible for rituximab treatment\n\n      * For all cancer type, neo-adjuvant and\u002For adjuvant chemotherapy is not regarded as chemotherapeutic regimen for metastatic or recurrent cancer unless recurrence within 6 months after the last dose of anti-cancer drugs as neo-adjuvant and\u002For adjuvant therapy.\n4. Subject must have at least 1 measurable lesion by RECIST 1.1\n5. Availability of tumor archival material or fresh biopsies\n6. ECOG performance status 0 or 1 and life expectancy ≥3 months\n7. Adequate hematologic function, hepatic function, and renal function\n8. Prior RT permitted if measurable disease exists outside the RT field or if disease progressed post-RT. RT must be completed ≥4 weeks before Cycle 1 Day 1\n9. Agree to use effective contraception\n10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n1. Treatment with nonpermitted drugs\n2. Prior treatment with a CD47 or SIRPα targeting agent\n3. Concurrent anticancer treatments\n4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period\n5. Previous malignant disease other than the target malignancy for this study\n6. Active infection requiring systemic therapy before Day 1\n7. Any active autoimmune disease, or history of autoimmune disease\n8. Any psychiatric or cognitive condition\n9. Known severe hypersensitivity reaction\n10. Pregnant or lactating\n11. Currently enrolled in another clinical study","ALL","19 Years",{"count":19,"type":20},62,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy",[26],"Advanced Cancer",[28,29,30,31],"IMC-002","Phase I","CD47","SIRPα","RECRUITING","2026-04-21",{"date":35,"type":36},"2026-04-24","ACTUAL",{"date":38,"type":36},"2022-06-02",{"date":40,"type":20},"2029-08-30",{"name":42,"class":43},"ImmuneOncia Therapeutics Inc.","INDUSTRY",3,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100544204","phase-2-a-study-of-imc-001-in-patients-with-metastatic-or-locally-advanced-tmb-h-solid-tumor-100544204","NCT06365840","A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor","PHASE 2 STUDY OF IMC-001 IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED TMB-H SOLID TUMOR","TMB-H","Inclusion Criteria:\n\n1. Documented TMB-H:≥ 16 mut\u002FMb, determined by the TruSightTM Oncology 500 NGS panel or OncomineTM Comprehensive Assay Plus\n2. Histologically or cytologically proven metastatic or locally advanced solid tumors.The participant must have at least one measurable tumor lesion per RECIST 1.1.\n3. Investigator has confirmation that participant's tumor tissue is available to be submitted to a central pathology laboratory.\n4. Adult age(as defined by respective country)\n5. The nature of the study and voluntarily sign an ICF\n6. ECOG 0 or1\n7. Prior systemic radiation therapy must be completed at least 4 weeks before the first dose of study drug. Prior focal radiotherapy must be completed at least 2 weeks before the first dose of study drug.\n8. At the time of the first dose of study drug at least 28 days since the last chemotherapy, immunotherapy, biological or investigational therapy, and have recovered from toxicities associated with such treatment to \\\u003C Grade 2.\n9. Adequate hematologic function, hepatic function, and renal function\n10. Female participants must meet one of the following criteria:\n\n    * Postmenopausal (≥24 months, or ≥12 months with FSH \\> 40 IU\u002FL),\n    * surgically incapable of bearing children (i.e., has had a hysterectomy or bilateral oophorectomy); or\n    * females of childbearing potential must agree to use a reliable form of contraceptive during the study treatment period and for at least 90 days following the last dose of study drug.\n11. Male participants must agree to use barrier contraception (i.e., condoms) for the duration of the study and for at least 90 days after the last dose of study drug.\n12. Predicted life expectancy of at least 16 weeks.\n\nExclusion Criteria:\n\n1. Previously treated with an anti-PD-L1 or anti-PD-1 antibody\n2. Known presence of symptomatic CNS metastases\n3. Any active autoimmune disease or a documented history of autoimmune disease\n4. Apparent active and known viral infection with HIV, hepatitis B virus or hepatitis C virus\n5. Pregnant or lactating",{"count":54,"type":20},30,[56],"PHASE2","The goal of this clinical trial is to determine the efficacy of IMC-001 in metastatic or locally advanced TMB-H solid tumor patients.",[51,59],"Histologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors",[61],"IMC-001,IMC-001-202,TMB-H","2026-04-16",{"date":64,"type":36},"2026-04-17",{"date":66,"type":36},"2025-01-13",{"date":68,"type":20},"2029-08",{"name":42,"class":43},4,""]