[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06823167":3,"trial-entities:NCT06823167":291,"trial-summary:NCT06823167":305},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":45,"sex":73,"minimum_age":74,"maximum_age":75,"healthy_volunteers":15,"eligibility_criteria":76,"std_ages":91,"locations":94,"central_contacts":282,"overall_officials":288,"references":289,"see_also_links":290},"NCT06823167","IM-1021-101","A Phase 1 Study of IM-1021 in Participants With Advanced Cancer","A Phase 1 Study of IM-1021 in Participants With Advanced Malignancies","RECRUITING","2029-02","2026-08","2026-08-10","2025-02-26","Immunome, Inc.","INDUSTRY",false,"IM-1021-101 is a Phase 1 study to determine the safety and effectiveness of IM-1021 in treating participants with advanced cancer.","IM-1021-101 is a 2-part Phase 1 first-in-human, open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, pharmacokinetics (PK), and preliminary anti-tumor activity of the ROR1 directed antibody-drug conjugate (ADC) IM-1021. IM-1021 will be administered to participants with advanced B-cell lymphomas and advanced solid tumors. Part A of the study is a dose escalation phase to evaluate safety and tolerability of IM-1021 and to determine recommended doses for further development. IM-1021 will be administered intravenously on an intermittent basis. The safety and tolerability of escalating doses of IM-1021 will be evaluated. Alternative dosing schedules may also be evaluated. Part B of the study is an expansion phase to further evaluate safety and tolerability of IM-1021 at candidate recommended doses in indication specific cohorts of participants. The safety and preliminary efficacy endpoints of this study will inform a preliminary risk-benefit assessment of IM-1021 in this patient population.",[19,20],"Solid Malignancies","Hematologic Malignancies",[],"INTERVENTIONAL","TREATMENT",[25],"PHASE1",{"count":27,"type":28},190,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","IM-1021","IM-1021 is an antibody-drug conjugate",[35,36],"Part A: IM-1021 Dose Escalation","Part B: IM-1021 Monotherapy Dose Expansion",[38,42],{"measure":39,"description":40,"timeFrame":41},"Safety and tolerability of IM-1021 in participants with advanced lymphomas and advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)","Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0, including serious adverse events (SAEs), AEs of interest (AEI), AEs leading to discontinuation, and deaths","From first dose to 37 days following last dose of study treatment",{"measure":43,"description":44,"timeFrame":41},"Determine the recommended dose(s) and schedule(s) of IM-1021 for further development","Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE v6.0, including SAEs, AEIs, AEs leading to discontinuation, and deaths",[46,50,53,55,57,59,61,65,69,71],{"measure":47,"description":48,"timeFrame":49},"Area under the concentration-time curve (AUC) of IM-1021 in participants with advanced lymphomas and advanced solid tumors","Pharmacokinetic (PK) parameter","Through 30-37 days following last dose of IM-1021 up to end of study",{"measure":51,"description":52,"timeFrame":49},"Concentration at end of infusion (Ceoi) of IM-1021 in participants with advanced lymphomas and advanced solid tumors","PK parameter",{"measure":54,"description":52,"timeFrame":49},"Maximum observed concentration (Cmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors",{"measure":56,"description":52,"timeFrame":49},"Time to maximum observed concentration (Tmax) of IM-1021 in participants with advanced lymphomas and advanced solid tumors",{"measure":58,"description":52,"timeFrame":49},"Trough Concentration of IM-1021 in participants with advanced lymphomas and advanced solid tumors",{"measure":60,"description":52,"timeFrame":49},"Apparent Terminal Half-Life (t1\u002F2) of IM-1021 in participants with advanced lymphomas and advanced solid tumors",{"measure":62,"description":63,"timeFrame":64},"Characterize the immunogenicity of IM-1021","Determined by the incidence of anti-drug antibodies (ADA) to IM-1021 from pre-infusion sample prior to each cycle.","From first dose to about 30 days following last dose of study treatment",{"measure":66,"description":67,"timeFrame":68},"To evaluate the preliminary anti-tumor activity of IM-1021 in participants with advanced lymphomas and advanced solid tumors","Objective response rate (ORR) as measured by Lugano Classification for participants with lymphoma (except small lymphocytic lymphoma \\[SLL\\]), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with SLL, and per Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 for participants with solid tumors","Week 6 until disease progression or participant discontinuation from study",{"measure":66,"description":70,"timeFrame":68},"Complete response rate (CRR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors",{"measure":66,"description":72,"timeFrame":68},"Disease control rate (DCR) as measured by Lugano Classification for participants with lymphoma (except SLL), per iwCLL criteria for participants with SLL, and per RECIST v.1.1 for participants with solid tumors","ALL","18 Years",null,{"inclusion":77,"exclusion":89,"raw_text":90},[78,79,80,81,82,83,84,85,86,87,88],"Mantle cell lymphoma (MCL)","Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)","Follicular lymphoma","Small lymphocytic lymphoma (SLL)","Marginal zone lymphoma","Pancreatic cancer","Non-squamous non-small cell lung cancer (NSCLC)","Malignant mesothelioma","Epithelial ovarian cancer. Participants with fallopian tube and\u002For peritoneal malignancies are also eligible.","Triple-negative breast cancer.","Liposarcoma",[],"Inclusion Criteria:\n\n1. Informed consent signed by the participant prior to conducting study-specific procedures\n2. ≥18 years of age\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n4. Histological or cytological diagnosis of:\n\n   Part A: advanced B-cell lymphomas or solid tumors, of the following subtypes:\n\n   B-cell Lymphomas:\n   * Mantle cell lymphoma (MCL)\n   * Diffuse large B-cell lymphoma (DLBCL) (including Richter's transformation)\n   * Follicular lymphoma\n   * Small lymphocytic lymphoma (SLL)\n   * Marginal zone lymphoma\n\n   Solid Tumors:\n   * Pancreatic cancer\n   * Non-squamous non-small cell lung cancer (NSCLC)\n   * Malignant mesothelioma\n   * Epithelial ovarian cancer. Participants with fallopian tube and\u002For peritoneal malignancies are also eligible.\n   * Triple-negative breast cancer.\n   * Liposarcoma\n\n   Other, unlisted histologies, if approved by the Sponsor Medical Monitor\n\n   Part B Cohorts B1, B2, and B3:\n\n   Histological or cytological diagnosis of the cohort-specific disease indication. Indications may include those listed in Inclusion Criterion 4.a\n5. Participants must have adequate organ function.\n6. Participants must have a negative pregnancy test, be willing to practice highly effective methods of birth control, use condoms, and refrain from oocyte\u002Fsperm donation, as applicable, as detailed in the protocol.\n7. Participants must have relapsed or refractory disease and have received all approved and available therapeutic options.\n8. Participants must have measurable disease as per the relevant response assessment framework: Lugano Classification for lymphoma (except SLL), per iwCLL criteria for SLL , and per RECIST v.1.1 for solid tumors.\n\nExclusion Criteria:\n\n1. Previously treated with an ADC with a topoisomerase-1 inhibitor payload, except: Participants with triple negative breast cancer may have received up to one prior ADC with a topoisomerase-1 inhibitor payload.\n2. Previously received a ROR1-targeted therapy (eg, ADC, cell therapy, or monoclonal antibody).\n3. History of an anaphylactic reaction to irinotecan or ≥ grade 3 GI toxicity to prior irinotecan.\n4. Life expectancy \\\u003C 12 weeks.\n5. Prior solid organ transplant.\n6. Participants with symptomatic ascites or pleural effusion. Participants who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis or catheter) are eligible.\n7. For participants with known active central nervous system (CNS) disease\n\n   1. For participants with solid tumors: Participant has a known active CNS primary tumor or metastases and\u002For carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg\u002Fday for at least 15 days prior to first dose of study medication. Participants who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) or other clinically appropriate imaging study if the participant is not able to undergo contrast-enhanced MRI and approved by the Sponsor Medical Monitor during the screening period.\n   2. For participants with lymphoma: Participant has active cerebral\u002Fmeningeal disease related to the underlying malignancy. Participants with a history of cerebral\u002Fmeningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.\n8. Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years. Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.\n9. Participant has certain other significant medical conditions including cardiac, pulmonary, and infectious disease as detailed in the protocol.\n10. Participant is pregnant, breastfeeding, or expecting to conceive within the projected duration of the study.",[92,93],"ADULT","OLDER_ADULT",[95,104,111,119,127,135,143,151,159,167,174,182,190,198,206,214,222,229,236,244,252,260,267,274],{"facility":96,"status":8,"city":97,"state":98,"zip":99,"country":100,"geoPoint":101},"City Of Hope","Duarte","California","91010","United States",{"lat":102,"lon":103},34.13945,-117.97729,{"facility":105,"status":8,"city":106,"state":98,"zip":107,"country":100,"geoPoint":108},"University of California","Los Angeles","90095",{"lat":109,"lon":110},34.05223,-118.24368,{"facility":112,"status":8,"city":113,"state":114,"zip":115,"country":100,"geoPoint":116},"Colorado Blood Cancer Institute","Denver","Colorado","80218",{"lat":117,"lon":118},39.73915,-104.9847,{"facility":120,"status":8,"city":121,"state":122,"zip":123,"country":100,"geoPoint":124},"Yale University Medical Center","New Haven","Connecticut","06510",{"lat":125,"lon":126},41.30815,-72.92816,{"facility":128,"status":8,"city":129,"state":130,"zip":131,"country":100,"geoPoint":132},"Tampa General Hospital","Tampa","Florida","33606",{"lat":133,"lon":134},27.94752,-82.45843,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":100,"geoPoint":140},"Emory Winship Cancer Institute","Atlanta","Georgia","30322",{"lat":141,"lon":142},33.749,-84.38798,{"facility":144,"status":8,"city":145,"state":146,"zip":147,"country":100,"geoPoint":148},"University of Iowa","Iowa City","Iowa","52242",{"lat":149,"lon":150},41.66113,-91.53017,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":100,"geoPoint":156},"Norton Cancer Institute","Louisville","Kentucky","40202",{"lat":157,"lon":158},38.25424,-85.75941,{"facility":160,"status":8,"city":161,"state":162,"zip":163,"country":100,"geoPoint":164},"University of Michigan","Ann Arbor","Michigan","48109",{"lat":165,"lon":166},42.27756,-83.74088,{"facility":168,"status":8,"city":169,"state":162,"zip":170,"country":100,"geoPoint":171},"START Midwest","Grand Rapids","49546",{"lat":172,"lon":173},42.96336,-85.66809,{"facility":175,"status":8,"city":176,"state":177,"zip":178,"country":100,"geoPoint":179},"University of Nebraska Medical Center","Omaha","Nebraska","68105",{"lat":180,"lon":181},41.25626,-95.94043,{"facility":183,"status":8,"city":184,"state":185,"zip":186,"country":100,"geoPoint":187},"Levine Cancer Institute","Charlotte","North Carolina","28204",{"lat":188,"lon":189},35.22709,-80.84313,{"facility":191,"status":8,"city":192,"state":193,"zip":194,"country":100,"geoPoint":195},"Gabrail Cancer Center","Canton","Ohio","44718",{"lat":196,"lon":197},40.79895,-81.37845,{"facility":199,"status":8,"city":200,"state":201,"zip":202,"country":100,"geoPoint":203},"Brown University","Providence","Rhode Island","02903",{"lat":204,"lon":205},41.82399,-71.41283,{"facility":207,"status":8,"city":208,"state":209,"zip":210,"country":100,"geoPoint":211},"Sarah Cannon Research Institute - Oncology Partners","Nashville","Tennessee","37203",{"lat":212,"lon":213},36.16589,-86.78444,{"facility":215,"status":8,"city":216,"state":217,"zip":218,"country":100,"geoPoint":219},"MD Anderson Cancer Center","Houston","Texas","77030",{"lat":220,"lon":221},29.76328,-95.36327,{"facility":223,"status":8,"city":224,"state":217,"zip":225,"country":100,"geoPoint":226},"NEXT Oncology","Irving","75039",{"lat":227,"lon":228},32.81402,-96.94889,{"facility":230,"status":8,"city":231,"state":217,"zip":232,"country":100,"geoPoint":233},"UT San Antonio Mays Cancer","San Antonio","78229",{"lat":234,"lon":235},29.42412,-98.49363,{"facility":237,"status":8,"city":238,"state":239,"zip":240,"country":100,"geoPoint":241},"University of Virginia","Charlottesville","Virginia","22903",{"lat":242,"lon":243},38.02931,-78.47668,{"facility":245,"status":8,"city":246,"zip":247,"country":248,"geoPoint":249},"Copenhagen University Hospital","Copenhagen","DK-2100","Denmark",{"lat":250,"lon":251},55.67594,12.56553,{"facility":253,"status":8,"city":254,"zip":255,"country":256,"geoPoint":257},"Centre Leon-Berard","Lyon","69008","France",{"lat":258,"lon":259},45.74906,4.84789,{"facility":261,"status":8,"city":262,"zip":263,"country":256,"geoPoint":264},"LITO, Institut Curie Hospital Gropu","Paris","75005",{"lat":265,"lon":266},48.85341,2.3488,{"facility":268,"status":8,"city":269,"zip":270,"country":256,"geoPoint":271},"Gustave Roussy","Villejuif","94805",{"lat":272,"lon":273},48.7939,2.35992,{"facility":275,"status":8,"city":276,"zip":277,"country":278,"geoPoint":279},"START - Fundacion Jimenez Diaz","Madrid","28040","Spain",{"lat":280,"lon":281},40.4165,-3.70256,[283],{"name":284,"role":285,"phone":286,"email":287},"Immunome Medical Monitor","CONTACT","425.939.7410","info@immunome.com",[],[],[],{"nct_id":4,"conditions":292,"biomarkers":304},[293,294,295,296,88,297,298,299,300,301,302,303],"Breast Carcinoma","Diffuse Large B-Cell Lymphoma","Follicular Lymphoma","Hematologic Neoplasm","Lung Non-Small Cell Carcinoma","Malignant Mesothelioma","Malignant Ovarian Neoplasm","Mantle Cell Lymphoma","Pancreatic Carcinoma","Small Lymphocytic Lymphoma","Solid Neoplasm",[],{"nct_id":4,"found":306,"summary":307,"prompt_version":317},true,{"design":308,"status":309,"heading":310,"summary":311,"follow_up":312,"word_count":313,"commitments":314,"compensation":315,"drugs_mentioned":316},"This is a Phase 1, first-in-human study that is open-label, meaning both you and the study team will know which treatment you are receiving. It will involve about 117 participants.","completed","Phase 1 Study of IM-1021 for Advanced Cancer","This study is testing a new treatment called IM-1021 for people with advanced solid tumors or blood cancers (like B-cell lymphomas). IM-1021 is an antibody-drug conjugate (a type of targeted therapy that delivers a drug directly to cancer cells). The main goal is to find out how safe IM-1021 is and what dose works best. Researchers will also look for early signs of how well it fights cancer. You might be able to join if you are at least 18 years old and have advanced cancer that has been diagnosed by a doctor. This study is currently recruiting about 117 participants.","Your safety and tolerability will be measured from the first dose to 37 days after your last dose of study treatment.",101,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]