[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07660055":3,"trial-entities:NCT07660055":219,"trial-summary:NCT07660055":228},{"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":23,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":54,"secondary_outcomes":70,"sex":118,"minimum_age":119,"maximum_age":120,"healthy_volunteers":121,"eligibility_criteria":122,"std_ages":163,"locations":166,"central_contacts":210,"overall_officials":216,"references":217,"see_also_links":218},"NCT07660055","CFML539A12101","Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in Patients With Solid Tumors","A Phase I Open-label, Multi-center Study to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Activity of [177Lu]Lu-DWJ155 and Safety and Imaging Properties of [68Ga]Ga-DWJ155 in Patients With Solid Tumors","RECRUITING","2032-05-24","2026-07","2026-07-28","2026-06-16","Novartis Pharmaceuticals","INDUSTRY",true,"The purpose of this phase I study is to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of \\[177Lu\\]Lu-DWJ155 and the safety and imaging properties of \\[68Ga\\]Ga-DWJ155 in patients with histologically or cytologically confirmed advanced HER2+, HR+\u002FHER2-negative, or triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), HER2-3+ or 2+ (ISH positive or negative) gastric\u002Fgastroesophageal junction (GEJ) cancer, and bladder cancer.","The study will be done in two parts. The first part is called \"escalation\" and the second part is called \"expansion\". In both parts of the study, patients will initially be imaged with a \\[68Ga\\]Ga-DWJ155 positron emission tomography (PET)\u002Fcomputed tomography (CT) or PET\u002Fmagnetic resonance imaging (MRI) scan. In the escalation part, different doses of \\[177Lu\\]Lu-DWJ155 will then be tested to identify recommended dose(s) (RD(s)) for further evaluation. The expansion part of the study will examine the safety and preliminary efficacy of \\[177Lu\\]Lu-DWJ155 at the RD(s) determined during the escalation part.\n\nIn both parts, there will be a safety follow-up period after the last \\[177Lu\\]Lu-DWJ155 administration.",[19,20,21,22],"Breast Cancer","Non-small Cell Lung Cancer (NSCLC)","Gastric\u002FGastroesophageal Junction (GEJ) Cancer","Bladder Cancer",[24,25,26,27,28,29,30,31,32,33],"Breast cancer","Non-small cell lung cancer (NSCLC)","Bladder cancer","Gastric\u002Fgastroesophageal junction (GEJ)","Radioligand therapy (RLT)","[177Lu]Lu-DWJ155","[68Ga]Ga-DWJ155","Human Epidermal Growth Factor Receptor 2 (HER2)","FML539","FKL480","INTERVENTIONAL","TREATMENT",[37],"PHASE1",{"count":39,"type":40},156,"ESTIMATED",[42,49],{"type":43,"name":30,"description":44,"armGroupLabels":45,"otherNames":48},"DIAGNOSTIC_TEST","Radioligand imaging agent",[46,47],"Dose Escalation","Dose Expansion",[33],{"type":50,"name":29,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","Radioligand therapy",[46,47],[32],[55,59,63,67],{"measure":56,"description":57,"timeFrame":58},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [177Lu]Lu-DWJ155","Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and imaging assessments qualifying and reported as AEs.","Up to approximately 53 months",{"measure":60,"description":61,"timeFrame":62},"Incidence of dose-limiting toxicities (DLTs) of [177Lu]Lu-DWJ155","A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness\u002Finjury or concomitant medications that occurs within the first treatment cycle. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.","Up to 6 weeks",{"measure":64,"description":65,"timeFrame":66},"Frequency of dose interruptions and reductions [177Lu]Lu-DWJ155","Number of participants with dose interruptions and\u002For reductions to assess the tolerability.","11 months",{"measure":68,"description":69,"timeFrame":66},"Dose intensity [177Lu]Lu-DWJ155","Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure",[71,74,77,80,83,87,90,93,96,99,103,106,110,114],{"measure":72,"description":73,"timeFrame":58},"Overall Response Rate (ORR) per RECIST v1.1","ORR is defined as the proportion of patients with a best overall response (BOR) of complete response (CR) or partial response (PR) as per local review and according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).",{"measure":75,"description":76,"timeFrame":58},"Disease Control Rate (DCR) per RECIST v1.1","DCR is defined as the proportion of patients with a BOR of CR, PR, or stable disease (SD) as per local review and according to RECIST v1.1.",{"measure":78,"description":79,"timeFrame":58},"Duration of Response (DOR) per RECIST v1.1","DOR is the time between the first documented response (CR or PR) and the date of progression as per local review and according to RECIST v1.1, or death due to any cause.",{"measure":81,"description":82,"timeFrame":58},"Progression-Free Survival (PFS) per RECIST v1.1","PFS is defined as the time from the date of start of treatment to the date of the first documented progression as per local review and according to RECIST v1.1 or death due to any cause.",{"measure":84,"description":85,"timeFrame":86},"Area under the concentration-time curve (AUC) of [177Lu]Lu-DWJ155","The pharmacokinetic (PK) analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. AUC will be determined by non-compartmental methods.","From pre-dose up to 168 hours after the end of the infusion on Day 1",{"measure":88,"description":89,"timeFrame":86},"Systemic clearance (CL) of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. CL will be determined by non-compartmental methods.",{"measure":91,"description":92,"timeFrame":86},"Maximum observed concentration (Cmax) of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Cmax will be determined by non-compartmental methods.",{"measure":94,"description":95,"timeFrame":86},"Volume of distribution during the terminal phase (Vz) of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. Vz will be determined by non-compartmental methods.",{"measure":97,"description":98,"timeFrame":86},"Terminal half-life (T1\u002F2) of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected blood radioactivity concentration data converted to mass units. T1\u002F2 will be determined by non-compartmental methods.",{"measure":100,"description":101,"timeFrame":102},"Urinary excretion of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected urine radioactivity concentration data converted to mass units. Urinary excretion will be derived based on the percentage of injected dose excreted in urine in each collection interval and overall.","From pre-dose up to 72 hours after the end of the infusion on Day 1",{"measure":104,"description":105,"timeFrame":102},"Renal clearance (CLr) of [177Lu]Lu-DWJ155","The PK analysis will be performed based on decay-corrected blood and urine radioactivity concentration data converted to mass units. CLr will be determined by non-compartmental methods.",{"measure":107,"description":108,"timeFrame":109},"Absorbed radiation dose in selected organs, tumor lesions and total body of [177Lu]Lu-DWJ155","Single Photon Emission Computed Tomography\u002FComputed Tomography (SPECT\u002FCT) images will be acquired to assess total body, organ and tumor lesion dosimetry.","Up to 168 hours after the end of the infusion on Day 1",{"measure":111,"description":112,"timeFrame":113},"Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) of [68Ga]Ga-DWJ155:","Incidence and severity of AEs and SAEs, including changes in laboratory values, vital signs, echocardiograms (ECGs), and cardiac imaging qualifying and reported as AEs.","Up to 3 days",{"measure":115,"description":116,"timeFrame":117},"Standard uptake values (SUVs) in normal tissues and selected tumor lesions of [68Ga]Ga-DWJ155","68Ga-DWJ155 positron emission tomography\u002Fcomputed tomography (PET\u002FCT) or positron emission tomography\u002Fmagnetic resonance imaging (PET\u002FMRI) imaging assessments will be performed to derive SUVs in normal tissues and selected tumor lesions.","Up to approximately 1.5 hours after the end of infusion","ALL","18 Years",null,false,{"inclusion":123,"exclusion":140,"raw_text":162},[124,125,126,127,128,129,130,131,132,127,128,133,134,135,136,137,138,139,131],"Male or female patients age ≥ 18 years.","Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:","Dose Escalation:","Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting","Advanced HR+\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting","Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting","Advanced NSCLC with AGAs who have received prior treatment","Measurable disease as determined by RECIST version 1.1.","Dose Expansion:","Advanced HR+\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting","Advanced HR-\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting","Advanced HR-\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting","Advanced NSCLC with AGAs, who have received prior treatment","Advanced NSCLC without known AGAs who have received prior treatment.","Advanced gastric\u002FGEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting","Advanced bladder cancer following disease progression after prior therapy in the advanced setting",[141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161],"Out-of-range laboratory values defined as:","Creatinine clearance \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured)","Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\>3.0 x ULN) or direct bilirubin \\> 1.5 x ULN","Alanine aminotransferase (ALT) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5 x ULN","Aspartate aminotransferase (AST) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5 x ULN","Lipase \\> 1.5 x ULN","Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL","Hemoglobin \\\u003C 9 g\u002FdL","Platelet count \\\u003C 100 x 109\u002FL","Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.","Use of transfusion support ≤4 weeks prior to imaging agent administration.","Impaired cardiac function or clinically significant cardiac disease.","Unmanageable urinary tract obstruction or urinary incontinence.","Any serious uncontrolled infection (acute or chronic).","Pregnant or breastfeeding women.","Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:","Prior treatment with any therapeutic radiopharmaceutical","\\\u003C 10 half-lives for any imaging radiopharmaceutical","≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy","≤ 6 months for lung-directed external beam radiotherapy","Patients with non-tumor uptake of \\[68Ga\\]Ga-DWJ155 in tissues or organs that, in the opinion of the investigator, increases the risk associated with \\[177Lu\\]Lu-DWJ155 treatment.","Inclusion Criteria:\n\n* Male or female patients age ≥ 18 years.\n* Patients with one of the following histologically or cytologically confirmed and documented malignancies who have progressed on or been intolerant to standard of care therapy, and are not considered appropriate for any standard therapy with proven benefit, in the investigator's judgment:\n* Dose Escalation:\n\n  * Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting\n  * Advanced HR+\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC without actionable genetic alterations (AGAs) with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC with AGAs who have received prior treatment\n  * Measurable disease as determined by RECIST version 1.1.\n* Dose Expansion:\n\n  * Advanced HER2+ breast cancer with disease progression after at least two prior lines of systemic therapy in the advanced setting\n  * Advanced HR+\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR+\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR-\u002FHER2-low breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced HR-\u002FHER2 0 breast cancer with disease progression after prior therapy in the advanced setting\n  * Advanced NSCLC with AGAs, who have received prior treatment\n  * Advanced NSCLC without known AGAs who have received prior treatment.\n  * Advanced gastric\u002FGEJ cancer with HER2 IHC 3+ or 2+ (ISH + or -), following disease progression after prior therapy in the advanced setting\n  * Advanced bladder cancer following disease progression after prior therapy in the advanced setting\n  * Measurable disease as determined by RECIST version 1.1.\n\nExclusion Criteria:\n\n* Out-of-range laboratory values defined as:\n\n  * Creatinine clearance \\\u003C 60 mL\u002Fmin (calculated using CKD-EPI 2021 formula, or measured)\n  * Total bilirubin \\> 1.5 x ULN (except for patients with Gilbert's syndrome who are excluded if total bilirubin \\>3.0 x ULN) or direct bilirubin \\> 1.5 x ULN\n  * Alanine aminotransferase (ALT) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if ALT \\> 5 x ULN\n  * Aspartate aminotransferase (AST) \\> 3 x ULN, except for patients with tumor involvement of the liver who are excluded if AST \\> 5 x ULN\n  * Lipase \\> 1.5 x ULN\n  * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Platelet count \\\u003C 100 x 109\u002FL\n* Initiation of hematopoietic colony stimulating factors, thrombopoietin mimetics, or erythroid stimulating agents initiated ≤ 2 weeks prior to imaging agent administration.\n* Use of transfusion support ≤4 weeks prior to imaging agent administration.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Unmanageable urinary tract obstruction or urinary incontinence.\n* Any serious uncontrolled infection (acute or chronic).\n* Pregnant or breastfeeding women.\n* Treatment with any of the following anti-cancer therapies prior to imaging agent administration within the stated timeframes:\n\n  * Prior treatment with any therapeutic radiopharmaceutical\n  * \\\u003C 10 half-lives for any imaging radiopharmaceutical\n  * ≤ 4 weeks for external beam radiation therapy (EBRT) or brachytherapy\n  * ≤ 6 months for lung-directed external beam radiotherapy\n* Patients with non-tumor uptake of \\[68Ga\\]Ga-DWJ155 in tissues or organs that, in the opinion of the investigator, increases the risk associated with \\[177Lu\\]Lu-DWJ155 treatment.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",[164,165],"ADULT","OLDER_ADULT",[167,185,194,202],{"facility":168,"status":8,"city":169,"state":170,"zip":171,"country":172,"contacts":173,"geoPoint":182},"Nebraska Cancer Specialists","Omaha","Nebraska","68130","United States",[174,179],{"name":175,"role":176,"phone":177,"email":178},"Marlene Bridwell","CONTACT","402-691-6972","mbridwell@nebraskacancer.com",{"name":180,"role":181},"Ralph Hauke","PRINCIPAL_INVESTIGATOR",{"lat":183,"lon":184},41.25626,-95.94043,{"facility":186,"status":8,"city":187,"state":188,"zip":189,"country":190,"geoPoint":191},"Novartis Investigative Site","Darlinghurst","New South Wales","2010","Australia",{"lat":192,"lon":193},-33.87939,151.21925,{"facility":186,"status":8,"city":195,"state":196,"zip":197,"country":198,"geoPoint":199},"Montreal","Quebec","H4A 3J1","Canada",{"lat":200,"lon":201},45.50884,-73.58781,{"facility":186,"status":8,"city":203,"state":204,"zip":205,"country":206,"geoPoint":207},"Kashiwa","Chiba","277-8577","Japan",{"lat":208,"lon":209},35.86224,139.97732,[211,214],{"name":13,"role":176,"phone":212,"email":213},"1-888-669-6682","novartis.email@novartis.com",{"name":13,"role":176,"phone":215},"+41613241111",[],[],[],{"nct_id":4,"conditions":220,"biomarkers":227},[221,222,223,224,225,226],"Bladder Carcinoma","Breast Carcinoma","Gastric Carcinoma","Gastroesophageal Junction Adenocarcinoma","Lung Non-Small Cell Carcinoma","Solid Neoplasm",[],{"nct_id":4,"found":15,"summary":229,"prompt_version":239},{"design":230,"status":231,"heading":232,"summary":233,"follow_up":234,"word_count":235,"commitments":236,"compensation":237,"drugs_mentioned":238},"This is an interventional study with a planned enrollment of 156 participants. It has two parts: an 'escalation' part to find the right dose, and an 'expansion' part to further test safety and effectiveness.","completed","Study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 for Solid Tumors","This study is looking at the safety and effects of two investigational drugs, [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155, in people with certain advanced solid tumors. These include breast cancer (HER2+, HR+\u002FHER2-negative, or triple negative), non-small cell lung cancer, gastric\u002Fgastroesophageal junction (GEJ) cancer, and bladder cancer. You may be able to join if your cancer has progressed after standard treatments or if you can't receive them. The study will first use [68Ga]Ga-DWJ155 for imaging, then test different doses of [177Lu]Lu-DWJ155 to find the safest and most effective amount. The main goal is to understand any side effects and how well the drugs work. The current status of this study is unclear.","You will be followed for safety for up to approximately 53 months after your last [177Lu]Lu-DWJ155 administration.",108,"You will first have an imaging scan with [68Ga]Ga-DWJ155. Then, you will receive doses of [177Lu]Lu-DWJ155, followed by a safety follow-up period after your last dose.","Not stated in the trial record.",[30,29],"v2"]