[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654712":3},{"organization":4,"outcomesModule":7,"designInfo":70,"detailedDescription":77,"studyPopulation":69,"armGroups":78,"interventions":100,"overallOfficials":106,"centralContacts":111,"locations":117,"responsibleParty":129,"collaborators":69,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":69,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":69,"enrollmentInfo":140,"targetDuration":69,"studyType":143,"phases":144,"briefSummary":147,"conditions":148,"keywords":152,"overallStatus":156,"whyStopped":69,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},{"fullName":5,"class":6},"Sotio Biotech Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":25,"otherOutcomes":69},[9,13,17,21],{"measure":10,"description":11,"timeFrame":12},"Part A: Maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of SOT106","MTD will be selected as guided by the time to-event Bayesian optimal interval (TITEBOIN) design. The RP2D will be selected based on integrated evaluation of the totality of clinical and preclinical data, for all dose levels tested.","At the end of Cycle 1 (one cycle is 21 days)",{"measure":14,"description":15,"timeFrame":16},"Part B: Optimal dose of SOT106 for subsequent clinical trials","Assessment of the safety and tolerability of two recommended doses under evaluation for dose optimization (RDOs) of SOT106 by evaluation of the occurrence of SOT106 related TEAEs, serious TEAEs, TEAEs leading to premature discontinuation of SOT106, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to NCI CTCAE Version 6.0","Cycle 1 Day 1 up to 30 days after the last dose (each cycle is 21 days)",{"measure":18,"description":19,"timeFrame":20},"Part B: Objective Response Rate (ORR) of SOT106","Percentage of participants who achieve a Best Overall Response of Complete Response (CR) or Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.","From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 10 months",{"measure":22,"description":23,"timeFrame":24},"Part B: Duration of Response (DoR) of SOT106","The time from the first documentation of objective response (CR or PR) to the first documented date of progressive disease (PD) according to RECIST v1.1.","From the date of first documented objective response until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, assessed up to approximately 10 months.",[26,30,34,37,40,44,47,51,55,58,61,64,67],{"measure":27,"description":28,"timeFrame":29},"Part A: Safety and Tolerability of SOT106","The occurrence of dose-limiting toxicities (DLTs), SOT106-related treatment-emergent adverse events (TEAEs), serious TEAEs, TEAEs leading to premature discontinuation of SOT106, deaths, and clinical laboratory test abnormalities of grade 3 or higher according to National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) Version 6.0","From Cycle 1 Day 1 (one cycle is 21 days) assessed for approximately 17 months",{"measure":31,"description":32,"timeFrame":33},"Part A: Characterization of maximum concentration (Cmax)","Cmax in plasma of total antibody, conjugated antibody and free MMAE","From Cycle 1 Day 1 up to approximately 17 months (each cycle is 21 days)",{"measure":35,"description":36,"timeFrame":33},"Part A: Characterization of time to maximum concentration (Tmax)","Time to maximum concentration of total antibody, conjugated antibody and free MMAE.",{"measure":38,"description":39,"timeFrame":33},"Part A: Characterization of area under the curve","Area under the concentration versus time curve calculated for total antibody, conjugated antibody and free MMAE.",{"measure":41,"description":42,"timeFrame":43},"Part A: Preliminary anticancer activity of SOT106","Tumor response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by LRRC15 expression","From Day 1 of Cycle 1 (one cycle is 21 days) until disease progression, initiation of new anticancer therapy, withdrawal of consent, or study discontinuation, whichever comes first, to be assessed up to approximately 17 months",{"measure":45,"description":46,"timeFrame":33},"Part A: Immunogenicity of SOT106 as Evaluated by Anti-Drug Antibody (ADA) Incidence","Proportion of participants who test positive for ADAs to SOT106.",{"measure":48,"description":49,"timeFrame":50},"Part B: Progression-Free Survival (PFS) of SOT106","Progression-free survival is defined as the time from Cycle 1 Day 1 to the first documented date of progressive disease (PD) according to RECIST v1.1, or death from any cause, whichever occurs first","From Cycle 1 Day 1 (one cycle is 21 days) until first documented disease progression or death from any cause, assessed up to approximately 10 months",{"measure":52,"description":53,"timeFrame":54},"Part B: Characterization of Cmax","Evaluation of the maximum plasma concentration (Cmax) for total antibody, conjugated antibody, and free MMAE payload.","From Cycle 1 Day 1 up to approximately 10 months (each cycle is 21 days)",{"measure":56,"description":57,"timeFrame":54},"Part B: Characterization of Tmax","Evaluation of the time to maximum plasma concentration (Tmax) for total antibody, conjugated antibody, and free payload.",{"measure":59,"description":60,"timeFrame":54},"Part B: Characterization of area under the curve","To characterize the total drug exposure over time (AUC) for total antibody, conjugated antibody, and free payload.",{"measure":62,"description":63,"timeFrame":54},"Part B: Immunogenicity of SOT106 as Evaluated by Anti-Drug Antibody (ADA) Incidence","Proportion of participants who test positive for ADAs to SOT106. The potential impact of ADA status on the pharmacokinetic (PK) profiles (Cmax, AUC, Tmax) of SOT106 will be evaluated by comparing PK data between ADA-positive and ADA-negative participants",{"measure":65,"description":66,"timeFrame":33},"Part A: Baseline LRRC15 expression in tumor tissue","Baseline LRRC15 expression in tumor tissue, as determined by immunohistochemistry (IHC) and quantified as the percentage of LRRC15-positive tumor cells",{"measure":68,"description":66,"timeFrame":54},"Part B: Baseline LRRC15 expression in tumor tissue",null,{"allocation":71,"interventionModel":72,"interventionModelDescription":73,"primaryPurpose":74,"observationalModel":69,"timePerspective":69,"maskingInfo":75},"RANDOMIZED","SEQUENTIAL","Part A: 4 cohorts, dose-escalation, Time-to-Event Bayesian Optimal Interval Design (TITE-BOIN) trial.\n\nPart B: Randomized, open-label dose optimization trial","TREATMENT",{"masking":76,"maskingDescription":69,"whoMasked":69},"NONE","The trial will consist of the following parts:\n\n* Part A: a multinational, multicenter, open-label, TITE-BOIN-guided trial to determine the MTD and RP2Ds, to evaluate the safety, PK, and preliminary efficacy of escalating doses of SOT106 in participants with LRRC15-positive advanced or metastatic osteosarcoma or soft tissue sarcoma (STS) who have received and\u002For have been determined to be intolerant of all standard of care therapy known to confer clinical benefit.\n* Part B: This is a randomized, multinational, multicenter, open-label dose optimization trial evaluating the two recommended doses for optimization (RDOs) identified in Part A. After the determination of the MTD in Part A and identification of RDOs, a randomized dose optimization part will be initiated to evaluate the two selected RDOs and to identify the optimal biological dose that offers the best balance between benefit and risk and to evaluate safety and efficacy of SOT106 in participants with advanced unresectable or metastatic osteosarcoma or STS who have no further standard treatment options.",[79,85,88,91,94,97],{"label":80,"type":81,"description":82,"interventionNames":83},"SOT106 (Part A) dose level 1","EXPERIMENTAL","Patients with LRRC15-positive advanced unresectable or metastatic osteosarcoma and soft tissue sarcoma treated with SOT106 given once every 21 days via the IV route over 45 (±15) minutes.",[84],"Biological: SOT106",{"label":86,"type":81,"description":82,"interventionNames":87},"SOT106 (Part A) dose level 2",[84],{"label":89,"type":81,"description":82,"interventionNames":90},"SOT106 (Part A) dose level 3",[84],{"label":92,"type":81,"description":82,"interventionNames":93},"SOT106 (Part A) dose level 4",[84],{"label":95,"type":81,"description":82,"interventionNames":96},"SOT106 (Part B) recommended dose for optimization 1",[84],{"label":98,"type":81,"description":82,"interventionNames":99},"SOT106 (Part B) recommended dose for optimization 2",[84],[101],{"type":102,"name":103,"description":104,"armGroupLabels":105,"otherNames":69},"BIOLOGICAL","SOT106","SOT106 is a LRRC15-directed monoclonal antibody conjugated to a linker-payload, Monomethyl auristatin E",[80,86,89,92,95,98],[107],{"name":108,"affiliation":109,"role":110},"Silvia Stacchiotti, M.D.","S.C. Oncologia Medica 2, Tumori Mesenchimali e Rari, Fondazione IRCCS, Istituto Nazionale dei Tumori","PRINCIPAL_INVESTIGATOR",[112],{"name":113,"role":114,"phone":115,"phoneExt":69,"email":116},"Richard Kapsa","CONTACT","(+420) 2241 74448","kapsa@sotio.com",[118],{"facility":119,"status":69,"city":120,"state":69,"zip":69,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":69},"Arensia Exploratory Medicine Research Unit, Institute of Oncology","Chisinau","Moldova","MD",{"type":124,"coordinates":125},"Point",[126,127],28.85938,47.00902,{"lat":127,"lon":126},{"type":130,"investigatorFullName":69,"investigatorTitle":69,"investigatorAffiliation":69,"oldNameTitle":69,"oldOrganization":69},"SPONSOR","100654712","phase-1-a-study-to-assess-safety-and-efficacy-of-sot106-in-patients-with-lrrc15-positive-advanced-unresectable-or-metastatic-osteosarcoma-or-soft-tissue-sarcoma-100654712",false,"NCT07801222","A Study to Assess Safety and Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma or Soft Tissue Sarcoma","A First-in-human Phase 1\u002F2 Trial to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of SOT106 in Patients With LRRC15-positive Advanced Unresectable or Metastatic Osteosarcoma and Soft Tissue Sarcoma","Inclusion Criteria:\n\n1. ≥18 years of age and body weight of ≥30 kg on the day of signing the prescreening ICF\n\n   * In the US after dose levels 1 and 2 have been declared safe (following DEC review of the safety and PK data from the first two adult dose levels), participants aged ≥12 years on the day of signing the prescreening ICF may be enrolled from dose level 3 onwards\n   * In the EU participants aged ≥12 years on the day of signing the prescreening ICF may be enrolled in backfilling cohorts once dose level 3 has been cleared in adults, following DEC review of safety, PK and efficacy data. In addition, preliminary signs of efficacy should have been observed in adults, based on the investigator's judgment.\n2. Participants ≥ 18 years of age are able to understand, sign, and provide written informed consent to participate in the trial. For participants under 18 years of age, their legal representative must provide a written informed consent. Participants aged 12 to 17 must be willing and able to provide a written assent.\n3. Performance status: Eastern Cooperative Oncology Group (ECOG) performance score 0-1. Patients with ECOG performance score 2 will be discussed with the sponsor's Medical Monitor to be agreed for inclusion.\n4. Estimated life expectancy ≥3 months as assessed by the investigator\n5. An appropriate candidate for experimental therapy as assessed by the investigator\n6. Availability of adequate tumor tissue from an archival biopsy (FFPE block or unstained slides) or willingness to undergo a fresh tumor biopsy. A minimum of ≥1% (1+) of cells must exhibit LRRC15 expression with an intensity of at least 1+ by IHC.\n\n   Note: Tumor samples will be sent to a central laboratory for LRRC15 expression analysis.\n7. Agrees not to participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period). For participants under 18 years of age, their legal representative must agree that they will not participate in other interventional clinical trials while enrolled in the present trial (with the exception of survival follow-up period).\n8. Absolute neutrophil count ≥1.5×109\u002FL, platelets ≥100×109\u002FL, hemoglobin ≥9 g\u002FdL\n9. Renal function:\n\n   * For participants ≥ 18 years of age: creatinine clearance ≥ 60 mL\u002Fmin calculated by Cockcroft-Gault formula\n   * For adolescent participants (aged 12-17 years): estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m², calculated using the Bedside Schwartz formula\n10. Bilirubin ≤1.5× upper limits of normal (ULN), ALT and AST ≤2.5×ULN; in case of liver involvement: AST and ALT ≤5×ULN.\n\n    * Participants with a documented history of Gilbert syndrome may be eligible if:\n    * Total bilirubin is ≤2.0 × ULN\n    * Direct (conjugated) bilirubin is within normal limits (≤ULN)\n    * There is no evidence of active liver disease, clinically significant hepatic impairment, hemolysis, or biliary obstruction, as determined by the investigator\n11. Prothrombin time\u002Finternational normalized ratio ≤1.5×ULN\n12. Albumin ≥3.0 g\u002FdL\n13. Serum concentrations of potassium, magnesium, and calcium with abnormalities of maximum grade 1 that should be treated according to standard practice\n14. Left ventricular ejection fraction (LVEF) ≥50% as determined by echocardiography or nuclear medicine methodology (MUGA)\n15. QTcF interval \\\u003C470 msec on screening ECG\n16. Ophthalmologic examination (slit lamp examination and Snellen Eye Chart) performed\n17. Histologically confirmed diagnosis of advanced unresectable or metastatic osteosarcoma or STS\n18. Measurable or non-measurable progression of disease according to RECIST 1.1 after previous treatment within 6 months prior to screening\n19. Received and\u002For determined to be refractory to, or intolerant of, standard therapies appropriate for their specific malignancy (osteosarcoma or soft tissue sarcoma)\n20. Previous cancer therapies:\n\n    * EU and Moldova: Previous cancer therapies and any agents that have not received regulatory approval for any indication must have been discontinued either ≥21 days or ≥ 5x half-life prior to day 1 of cycle 1, whichever is longer; toxicities of earlier anticancer therapy must be grade ≤1 at the time of screening and prior to cycle 1 day 1 (exception: alopecia); mitomycin-C and nitrosoureas must have been discontinued for ≥42 days.\n    * US: eligibility should be determined based on patient recovery from clinically significant AEs from their most recent therapy or intervention prior to study enrollment\n21. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and one of the following conditions applies:\n\n    * Not a woman of childbearing potential (WOCBP). For the definition of a WOCBP\n    * A WOCBP who agrees to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of SOT106\n22. Male participants must agree to use a condom during the treatment period and for at least 6 months after the last dose of SOT106. Male participants wishing to become a father during or after the trial should consider sperm preservation. WOCBP partners of male participants should use highly effective contraception methods for 6 months after SOT106 discontinuation\n\nExclusion Criteria:\n\n1. Received radiation therapy ≤14 days before day 1 of cycle 1 or not recovered to grade ≤1 from treatment-related side effects\n2. Any prior systemic therapy for metastatic cancer other than osteosarcoma and STS; exception: stable disease under hormonal treatment for prostate cancer, stable disease under hormonal treatment for breast cancer; radiochemotherapy is allowed if such treatment is completed at least 4 weeks prior to day 1 of cycle 1; participants must have recovered to grade ≤1 from all side effects (exception: alopecia). Participants must not receive any concurrent antitumor therapy while participating in the trial. In exceptional circumstances where urgent palliative radiotherapy to symptomatic non-target lesions is clinically indicated, the case must be reviewed with the Principal Investigator and the intervention must receive prior approval from the sponsor.\n3. Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial interventions; the full series (e.g., both doses of a two-dose vaccination series) should be completed prior to dosing if feasible.\n4. Time since last transfusion of red blood cells ≤14 days before day 1 of cycle 1\n5. Concomitant use of strong CYP3A4 inhibitors or P-gp inhibitors without an adequate washout period of 7 days or 5 half-lives, whichever is longer, prior to the first SOT106 administration\n6. Severe preexisting medical conditions as per judgment of the investigator\n7. History of interstitial pneumonitis or pulmonary fibrosis\n8. Symptomatic central nervous system malignancy. Participants with asymptomatic or treated central nervous system metastases may be eligible if they are not treated with corticosteroids or anticonvulsants and the disease is stable for at least 60 days.\n9. Peripheral sensory neuropathy grade ≥2\n10. Active infection requiring systemic therapy that is not clinically controlled before the signature of the prescreening ICF\n11. Known symptomatic HIV positive, symptomatic active HBV, or symptomatic active HCV\n\n    Note:\n    * Participants with HIV will be eligible if:\n\n      * CD4+ T-cell counts ≥350 cells\u002FμL\n      * they have no history of AIDS-defining opportunistic infections\n      * they are not currently on HIV therapy\n    * Participants with HBV will be eligible if there is serologic evidence of a resolved prior HBV infection (HBsAg-negative and HBcAb-positive)\n    * Participants with HCV will be eligible if they have completed curative antiviral treatment and have HCV viral load below the limit of quantification\n12. Alcohol or drug abuse as determined by the investigator\n13. Psychiatric condition or social situation that, in the opinion of the investigator, preclude that the participant is able to comply with trial requirements\n14. New York Heart Association class ≥2 heart failure, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, myocardial infarction, cerebrovascular accident or hypertensive crisis within 6 months prior to day 1 of cycle 1\n15. History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes)\n16. History or family history of congenital long QT syndrome\n17. Bradycardia (\\\u003C50 beats per minute)\n18. Family history of sudden cardiac death before age 50\n19. Major surgical intervention ≤28 days prior to prescreening ICF signature or incomplete wound healing after surgical intervention\n20. Hypersensitivity or intolerance to any component of trial intervention","ALL","12 Years",{"count":141,"type":142},70,"ESTIMATED","INTERVENTIONAL",[145,146],"PHASE1","PHASE2","SOT106 is a special cancer medicine designed to find and kill certain cancer cells that carry a marker called LRRC15, while causing less harm to healthy cells. The study consists of two parts, Part A and Part B. The goal of Part A is to collect information about SOT106, understand its effects, and see whether it is safe and well tolerated at different dose levels. Part B of the study collects information on which of the two selected safe dose levels chosen in Part A gives the best balance between benefit and risk.",[149,150,151],"Osteosarcoma Metastatic","Soft Tissue Sarcoma (STS)","Osteosarcoma, Advanced",[153,154,150,155],"Dose escalation","Osteosarcoma","Dose optimization","NOT_YET_RECRUITING","2026-09-02",{"date":159,"type":160},"2026-09-03","ACTUAL",{"date":162,"type":142},"2026-09-30",{"date":164,"type":142},"2030-05-21",{"name":166,"class":6},"SOTIO Biotech a.s.",1]