[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460490":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":84,"studyPopulation":76,"armGroups":85,"interventions":91,"overallOfficials":96,"centralContacts":100,"locations":106,"responsibleParty":137,"collaborators":76,"id":139,"slug":140,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":76,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":76,"enrollmentInfo":148,"targetDuration":76,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":157,"overallStatus":129,"whyStopped":76,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"ImmuneOncia Therapeutics Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":76},[9,13],{"measure":10,"description":11,"timeFrame":12},"Incidence of Dose-Limiting Toxicities (DLTs)","To determine maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002","21 days",{"measure":14,"description":15,"timeFrame":16},"Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]","* clinically significant changes in physical examination, vital signs, ECG parameters, clinical laboratory tests, AEs\n* Immunogenicity: anti-IMC-002 antibody","through study completion, an average of 1 year",[18,21,24,27,30,33,36,40,43,46,49,52,55,58,61,64,67,70,73],{"measure":19,"description":20,"timeFrame":16},"Pharmacokinetics Endpoint : Cmax","maximum observed serum concentration (Cmax) of IMC-002",{"measure":22,"description":23,"timeFrame":16},"Pharmacokinetics Endpoint : Ctrough","minimum observed serum concentration immediately before dosing (Ctrough) of IMC-002",{"measure":25,"description":26,"timeFrame":16},"Pharmacokinetics Endpoint : Tmax","time of the maximum observed serum concentration (Tmax) of IMC-002",{"measure":28,"description":29,"timeFrame":16},"Pharmacokinetics Endpoint : AUC","Area Under the Serum Concentration-Time Curve (AUC) of IMC-002",{"measure":31,"description":32,"timeFrame":16},"Pharmacokinetics Endpoint : CL","total body clearance (CL) of IMC-002",{"measure":34,"description":35,"timeFrame":16},"Pharmacokinetics Endpoint : t½","terminal half-life (t½) of IMC-002",{"measure":37,"description":38,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : BOR","best overall response (BOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).","Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT\u002FCT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.",{"measure":41,"description":42,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : ORR","objective response rate (ORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).",{"measure":44,"description":45,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : DCR","disease control rate (DCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).",{"measure":47,"description":48,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : DOR","duration of response (DOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).",{"measure":50,"description":51,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : TTP","time-to-progression (TTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).",{"measure":53,"description":54,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : PFS","progression-free survival (PFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).",{"measure":56,"description":57,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iBOR","Immune best overall response(iBOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":59,"description":60,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iORR","Immune objective response rate(iORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":62,"description":63,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iDCR","Immune disease control rate(iDCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":65,"description":66,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iDOR","Immune duration of response(iDOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":68,"description":69,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iTTP","Immune time-to-progression(iTTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":71,"description":72,"timeFrame":39},"Efficacy endpoints based on tumor assessment (Part2) : iPFS","Immune progression-free survival(iPFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).",{"measure":74,"description":75,"timeFrame":16},"Efficacy endpoints based on tumor assessment (Part2) : overall survival (OS)","overall survival (OS)",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":80,"primaryPurpose":81,"observationalModel":76,"timePerspective":76,"maskingInfo":82},"NA","SINGLE_GROUP","Part 1: Dose Escalation Part 2: Expansion cohort","TREATMENT",{"masking":83,"maskingDescription":76,"whoMasked":76},"NONE","The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002.\n\nMultiple-dose levels of IMC-002 will be tested in subjects with advanced cancer.",[86],{"label":87,"type":88,"description":87,"interventionNames":89},"IMC-002","EXPERIMENTAL",[90],"Biological: IMC-002",[92],{"type":93,"name":87,"description":94,"armGroupLabels":95,"otherNames":76},"BIOLOGICAL","Part 1: Dose escalation IMC-002 5, 10, 20, and 30 mg\u002Fkg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg\u002Fkg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of \\\u003C 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg\u002Fm2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg\u002Fm2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) and pancreatic ductal adenocarcinoma (PDAC) Cohort, Lenvatinib 8 mg once daily (body weight of \\\u003C 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg\u002Fm2 IV infusion on Day 1 of each cycle",[87],[97],{"name":98,"affiliation":5,"role":99},"HEUNG TAE KIM, MD","STUDY_DIRECTOR",[101],{"name":102,"role":103,"phone":104,"phoneExt":76,"email":105},"JIHEE KWON","CONTACT","+82 2 6283 5064","jhkwon@immuneoncia.com",[107,118,127],{"facility":108,"status":109,"city":110,"state":76,"zip":76,"country":111,"countryCode":76,"cosmosGeoPoint":112,"geoPoint":117,"contacts":76},"National Cancer Center","ACTIVE_NOT_RECRUITING","Goyang-si","South Korea",{"type":113,"coordinates":114},"Point",[115,116],126.835,37.65639,{"lat":116,"lon":115},{"facility":119,"status":120,"city":121,"state":76,"zip":76,"country":111,"countryCode":76,"cosmosGeoPoint":122,"geoPoint":126,"contacts":76},"Asan Medical Center, Republic of Korea","COMPLETED","Seoul",{"type":113,"coordinates":123},[124,125],126.9784,37.566,{"lat":125,"lon":124},{"facility":128,"status":129,"city":121,"state":76,"zip":76,"country":111,"countryCode":76,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"Samsung Medical Center","RECRUITING",{"type":113,"coordinates":131},[124,125],{"lat":125,"lon":124},[134],{"name":135,"role":136,"phone":76,"phoneExt":76,"email":76},"Jung Yong Hong, MD","PRINCIPAL_INVESTIGATOR",{"type":138,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR","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, PDAC Cohort:\n   1. Histologically or cytologically proven metastatic or locally advanced of pancreatic ductal adenocarcinoma\n   2. Must have received one or two prior anti-cancer systemic regimen and adequate for administration of lenvatinib.\n\n   3-6. 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":149,"type":150},86,"ESTIMATED","INTERVENTIONAL",[153],"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",[156],"Advanced Cancer",[87,158,159,160],"Phase I","CD47","SIRPα","2026-09-22",{"date":163,"type":164},"2026-09-25","ACTUAL",{"date":166,"type":164},"2022-06-02",{"date":168,"type":150},"2030-08-31",{"name":5,"class":6},3]