[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659919":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":58,"studyPopulation":58,"armGroups":66,"interventions":80,"overallOfficials":98,"centralContacts":103,"locations":112,"responsibleParty":132,"collaborators":134,"id":138,"slug":139,"hasResults":140,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":140,"sex":146,"minAge":147,"maxAge":58,"enrollmentInfo":148,"targetDuration":58,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":58,"overallStatus":158,"whyStopped":58,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"ITERIA BIOPHARMA, S.L.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":58},[9,13],{"measure":10,"description":11,"timeFrame":12},"RP2D of ITR-251","During dose-escalation phase, patients will be included sequentially into cohorts with escalating dose levels. RP2D is defined as the highest dose level at which \\\u003C33% of patients reported a dose limiting toxicities (DLT) (i.e. ≤ 1 DLT out of 6 patients) providing the safety profile is amenable.\n\nDLT is defined as any of the following events during the DLT reporting period:\n\n1. Hematologic toxicities:\n\n   1. Grade (G) 3 febrile neutropenia lasting \\> 7 days\n   2. G4 thrombocytopenia lasting \\> 7 days\n   3. G3 thrombocytopenia with clinically significant bleeding\n   4. Gr ≥3 anemia requiring urgent transfusion support\n2. Non-hematologic toxicities:\n\n   1. Any G ≥3 non-hematologic toxicity, excluding non relevant nausea, vomiting, or diarrhea, laboratory abnormalities or cutaneous events.\n   2. Hypertensive crisis\n   3. Severe serotonin syndrome\n   4. G ≥3 arrhythmia\n   5. QTcF prolongation \\>500 ms or increase \\>60 ms from baseline\n3. Received \\\u003C 75% of the intended ITR-251 dose during the DLT period due to toxicity","DLT period is 28 days since first dose of study treatment",{"measure":14,"description":15,"timeFrame":16},"Treatment-emergent adverse events","incidence of treatment-emergent adverse events (TEAEs) classified by grade and seriousness","Throughout the study period, approximately 12 months",[18,21,24,28,31,34,37,40,43,46,49,52,55],{"measure":19,"description":20,"timeFrame":16},"Duration of treatment","Defined as the time from the first dose of ITR-251 to the permanent discontinuation of ITR-251 treatment for any reason. Patients with treatment ongoing will have their last administration date as the last date on treatment for timing calculation.",{"measure":22,"description":23,"timeFrame":16},"Incidence of treatment modifications","number of patients requiring treatment dose reduction, interruptions and permanent discontinuations for management of TEAEs",{"measure":25,"description":26,"timeFrame":27},"Pharmacokinetic (PK) profile","Cmax and Tmax of ITR-251 will be reported. The study will include analysis of patients in fasted and fed conditions","Within the first months of treatment with ITR-251",{"measure":29,"description":30,"timeFrame":16},"Objective response rate (ORR)","Proportion of patient who achieved a complete response (CR) or partial response (PR) according to prostate cancer working group (PCWG4) (in case of prostate cancer) or RECIST V1.1 (all other tumors). ORR will be assessed by investigators using computed tomography (CT) or magnetic resonance imaging (MRI) scans.",{"measure":32,"description":33,"timeFrame":16},"Time to progression (TTP)","Only for dose-escalation phase. Defined as the time elapsed from first dose of ITR-251 treatment until the date of disease progression assessed by the local investigators according to RECIST V1.1 criteria",{"measure":35,"description":36,"timeFrame":16},"Radiological progression-free survival (rPFS)","Only dose-expansion phase. Assessed by investigator according to PCWG4 Criteria and defined from the day of first dose of ITR-251 to the day the first event of radiological progression or death (due to any cause) is recorded. rPFS will be estimated by Kaplan-Meier method. Patients who are alive without evidence of radiological progression at their last imaging assessment will be censored at that date.",{"measure":38,"description":39,"timeFrame":16},"Prostate specific antigen (PSA) response rates","Only dose-expansion phase. defined as blood PSA \\\u003C0.02 ng\u002FmL confirmed with a subsequent PSA value \\\u003C0.02 ng\u002FmL 3 or more weeks later. Rate of absolute PSA response is defined as the number of subjects with absolute PSA response, divided by the total number of subjects evaluable for absolute PSA response (with high PSA levels at baseline).",{"measure":41,"description":42,"timeFrame":16},"Time to PSA progression","Only dose-expansion phase. Defined as the time elapsed from first dose of ITR-251 treatment until the date of any increase in PSA level from baseline\u002Fnadir, confirmed by one additional rising PSA measurement and with a minimum absolute increase of 0.2 ng\u002FmL.",{"measure":44,"description":45,"timeFrame":16},"Duration of Response (DoR)","Only dose-expansion phase. Time from first response (CR or PR), according to ORR definition for the trial, to the date of the documented disease progression (PD) as determined using RECIST 1.1 \u002F PCWG4 criteria (patients with mCRPC) or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.",{"measure":47,"description":48,"timeFrame":16},"Disease control rate (DCR)","Only dose-expansion phase. Defined as the proportion of patients who had CR, PR, or a stable disease (SD) maintained at least for 3 months as their best response throughout the study period, defined as PCWG4 criteria.",{"measure":50,"description":51,"timeFrame":16},"Time to pain progression (TTPP)","Only dose-expansion phase.\n\nTime-to-pain progression is defined as the time (days) from the first dose of study treatment (ITR-251) date, to the date of pain progression measured according to Brief Pain Inventory (BPI). Pain progression is defined in patients in the 'pain evaluable' population as:\n\nan increase of 2 or more points in the BPI's \"worst pain in 24 hours\"-score from baseline observed at 2 consecutive evaluations ≥4 weeks apart, or initiation of short or long-acting opioid use for pain.",{"measure":53,"description":54,"timeFrame":16},"Time to next treatment (TTNT)","Only dose-expansion phase. This is the interval of time between first dose of study treatment and the first day of initiation of a next line of systemic antineoplastic therapy after the initial scheduled treatment.",{"measure":56,"description":57,"timeFrame":16},"Overall survival (OS)","Only dose-expansion phase. OS will be measured from the date of first dose of study treatment (ITR-251) to the date of death whatever the cause of death. OS will be estimated by Kaplan-Meier method. Patients who are alive are censored at the date of the most recent follow-up examination.",null,{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":58,"timePerspective":58,"maskingInfo":64},"NON_RANDOMIZED","SEQUENTIAL","First-in-human, open label, Phase I\u002FIb Clinical Trial","TREATMENT",{"masking":65,"maskingDescription":58,"whoMasked":58},"NONE",[67,73],{"label":68,"type":69,"description":70,"interventionNames":71},"Dose-Escalation","EXPERIMENTAL","Dose-Escalation will establish a recommended Phase 2 dose (RP2D) of ITR-251",[72],"Drug: ITR-251",{"label":74,"type":69,"description":75,"interventionNames":76},"Dose-Expansion","On completion of dose-escalation, dose-expansion will determine safety and preliminary efficacy of ITR-251 at RP2D in combination with ARPIs for mCRPC",[77,78,79],"Drug: ITR-251 at RP2D","Drug: ARPI therapy","Drug: Androgen Deprivation Therapy (ADT)",[81,86,90,94],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":58},"DRUG","ITR-251","ITR-251 is a potent and selective inhibitor of Monoamine Oxidase A (MAO-A) with reversible inhibition and limited capacity for blood brain barrier (BBB) crossing.\n\nFour dose levels will be tested. Dose could be also reduced to dose level -1.",[68],{"type":82,"name":87,"description":88,"armGroupLabels":89,"otherNames":58},"ITR-251 at RP2D","ITR-251 is a potent and selective inhibitor of MAO-A with reversible inhibition and limited capacity for blood brain barrier (BBB) crossing.\n\nDose at RP2D",[74],{"type":82,"name":91,"description":92,"armGroupLabels":93,"otherNames":58},"ARPI therapy","ARPIs are blockers of the androgen receptor pathway, which play a pivotal role in treating prostate cancer, showing significant efficacy across different disease stages. ARPi will be given according to standard clinical practice",[74],{"type":82,"name":95,"description":96,"armGroupLabels":97,"otherNames":58},"Androgen Deprivation Therapy (ADT)","ADTs reduce availability of male hormones (androgens like testosterone) that fuel cancer growth and it is the backbone for many standard treatment combinations in prostate cancer, including in the castration resistant setting in combination with ARPis. ADT will be given according to standard clinical practice.",[74],[99],{"name":100,"affiliation":101,"role":102},"Josep M Piulats, M.D.; Ph.D.","Institut Català d'Oncologia (ICO)","STUDY_CHAIR",[104,109],{"name":105,"role":106,"phone":107,"phoneExt":58,"email":108},"MFAR Clinical Research","CONTACT","0034934344412","investigacio@mfar.net",{"name":110,"role":106,"phone":58,"phoneExt":58,"email":111},"Cristina López Sanjurjo","clopez@iteriabiopharma.com",[113],{"facility":101,"status":58,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"L'Hospitalet de Llobregat","Barcelona","08908","Spain","ES",{"type":120,"coordinates":121},"Point",[122,123],2.10028,41.35967,{"lat":123,"lon":122},[126,129],{"name":127,"role":106,"phone":107,"phoneExt":58,"email":128},"A responsible person Designated by the Sponsor","investigacion@mfar.net",{"name":130,"role":131,"phone":58,"phoneExt":58,"email":58},"A Principal Investigator Designated by the Sponsor, M.D.; Ph.D.","PRINCIPAL_INVESTIGATOR",{"type":133,"investigatorFullName":58,"investigatorTitle":58,"investigatorAffiliation":58,"oldNameTitle":58,"oldOrganization":58},"SPONSOR",[135],{"name":136,"class":137},"MFAR","OTHER","100659919","phase-1-itr-251-in-patients-with-advanced-solid-tumors-100659919",false,"NCT07870096","ITR-251 in Patients With Advanced Solid Tumors","Phase I\u002FIb Trial of Single Agent ITR-251 in Patients With Advanced Solid Tumors With an Expansion-Phase in Metastatic Castration-Resistant Prostate Cancer","STRIVE-251","Inclusion Criteria:\n\n1. Patients must be fully informed about the study and sign the informed consent form (ICF) before any study specific assessment.\n2. Patients ≥18 years old at the time of signing the informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 prior to study entry.\n4. Have measurable disease per RECIST v1.1 or PCWG4 criteria (for mCRPC).\n5. Adequate organ and bone marrow function as follows (subject must not have received any growth factor within 4 weeks or a blood transfusion within 7 days of the hematology laboratory):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 x109\u002FL;\n   2. Platelets ≥ 100 x109\u002FL;\n   3. Hemoglobin ≥ 9.0 g\u002Fdl;\n   4. Prothrombin time (PT) or international normalised ratio (INR) ≤1.5 × ULN;\n   5. Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's disease ≤ 5.0 x ULN;\n   6. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;\n   7. Creatinine ≤ 1.5 x ULN;\n   8. creatinine clearance (CrCl) ≥ 30 mL\u002Fmin;\n   9. Albumin \\> 25 g\u002FL.\n\n   Criteria Specific for Dose-escalation phase:\n6. Patients with any histologically or cytologically confirmed solid tumor at advanced or metastatic stage.\n\n   Note: glioblastoma, cholangiocarcinoma, gastric, liver, or nasopharyngeal carcinomas are excluded given the potential negative impact of MAO-A inhibition and effect in reactive oxygen species (ROS) metabolism in these tumor types.\n7. Disease progression to standard of care therapies within one month prior to study entry.\n\n   Note: Patients should have no available standard of care therapy likely to confer clinical benefit in the opinion of the investigator.\n8. Life expectancy \\> 6 months.\n\n   Criteria Specific for Dose-expansion phase:\n9. Patients with histologically or cytologically confirmed mCRPC receiving ARPi treatment (including: abiraterone, apalutamide, enzalutamide or darolutamide) and experiencing PSA progression (any increase above 0.2 ng\u002FmL in PSA level from baseline\u002Fnadir, confirmed by one additional rising PSA measurement at least 21 days apart) confirmed.\n\n   Note: the inclusion of patients will be limited to 50% with abiraterone and 50% with androgen receptor targeted agents (ARTAs).\n\n   Note: Patients should have castration resistant prostate cancer (CRPC) as defined by PCWG4 criteria.\n\n   Note: patients with prior therapies for locoregional disease and\u002For initiating ARPis in the hormone-sensitive that progressed to CRPC setting are eligible.\n\n   Note: Patients candidates for concurrent treatment with androgen deprivation therapy (ADT) according to the standard clinical practice are allowed.\n10. Patients with a Charlson score ≤ 3 prior to study entry.\n\n    Contraceptive and other requirements:\n11. Participants who have pregnant partners must use a condom and those with partners of childbearing potential must use a condom and another adequate birth control measure if engaging in sexual activities during the study treatment period and for at least 4 weeks after the last dose of ITR-251. A highly effective method of birth control is defined as those which result in low failure rate (i.e., less than 1% per year) when used consistently and correctly.\n12. During the dose-escalation phase, women of childbearing potential (WOCBP) and their partners must agree to use a highly effective method of birth control during the study treatment period and for at least 4 weeks after the last dose of ITR-251.\n13. Are willing and able to comply with scheduled visits, treatment schedule, the planned trial assessments, lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions.\n\nExclusion Criteria:\n\n1. For Dose-escalation phase only: women pregnant or breastfeeding.\n2. For Dose-escalation phase only: Patients with glioblastoma, cholangiocarcinoma, gastric, liver, or nasopharyngeal carcinomas.\n3. For dose-expansion phase only: patients with symptomatic or radiologic PD requiring or tributary for treatment with docetaxel or other concurrent anticancer therapies other than ADT and ARPi.\n4. Patients with brain metastasis.\n5. Required concurrent treatment with other investigational medicinal products or participation in other clinical trials.\n6. Previous treatment with MAO-A inhibitors.\n7. Treatment with antidepressant or psychostimulants, opioids or analgesics, antitussives and antihistaminics listed as prohibited concomitant medication within one month or 5 halflives, whichever is longer, prior to the study entry or patients with foreseen potential requirement of antidepressants during the study.\n8. Previous systemic anticancer treatments should have been discontinued 15 days prior to study entry.\n\n   Note for dose-expansion phase: Continuous treatment with ADT and ARPi before start of study treatment is allowed.\n9. Residual toxicity from prior anticancer therapy that are NCI-CTCAE v6.0 Grade ≥ 2, except for Grade ≥ 2 alopecia.\n\n   Note: Stable chronic Grade 2 toxicities from previous treatments may be eligible per the judgement of the investigator.\n10. Have had major surgery (not including diagnostic surgery) within the 4 weeks prior to the first dose of trial treatment or are planned to undergo major surgery during the course of the trial.\n11. Known secondary active malignancy requiring treatment within the last 2 years prior to study entry.\n\n    Note: Patients that have secondary malignancies that have undergone potentially curative therapy are eligible.\n12. Body mass index (BMI) \\\u003C 15 kg\u002Fm2 or patients with symptomatic malnutrition (GLIM criteria).\n13. Uncontrolled hypertension despite appropriate medical therapy (blood pressure \\[BP\\] \\> 160 mmHg systolic and 90 mmHg diastolic at 2 separate measurements no more than 60 minutes apart during the screening visit).\n\n    Note: patients may be rescreened after adjustment of antihypertensive medications.\n14. History of hypertensive crisis.\n15. Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, psychosis, etc.).\n16. Patients with a pre-existing diagnosis of severe insomnia (Grade 3 according to CTCAE v6.0) or primary sleep disorders (e.g., severe obstructive sleep apnea, narcolepsy) who have required adjustments to their pharmacological treatment in the 28 days prior to inclusion.\n17. Patients at high risk (i.e. categories 4, 5, or any suicide behaviors \\[6-9\\]) of suicide according to the validated Columbia Scale (C-SSRS).\n18. Patients with ongoing or active severe infections requiring treatment.\n19. Patients with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.\n20. History of stroke or significant cerebrovascular disease (ie, transient ischemic attack) within 6 months prior to initiation of study intervention.\n21. History of clinically significant cardiac disease within 6 months prior to the initiation of study intervention, including but not limited to unstable angina, acute myocardial infarction, endoscopic or open-heart cardiac surgery, or heart failure classified as New York Heart Association Grade ≥ 2, left ventricular ejection fraction \\\u003C45% or interval corrected by Fridericia (QTcF) \\>470 ms (for women) and \\>450 ms (for men) or clinically significant arrhythmias.\n22. History of clinically significant respiratory disease within 6 months prior to the initiation of study intervention, including severe chronic obstructive pulmonary disease or asthma.\n23. History of noninfectious interstitial lung disease (ILD) \u002Fpneumonitis \u002Fradiation pneumonitis that required steroids or has current ILD\u002Fpneumonitis.\n24. Clinically significant gastrointestinal disorder including bleeding, occlusion, diarrhoea \\>Grade 1, malabsorption syndrome, ulcerative colitis, inflammatory bowel disease or partial bowel obstruction.\n25. Any intercurrent gastrointestinal condition that may affect the ingestion and absorption of ITR-251.\n26. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ITR-251 or other monoamine oxidase inhibitors.\n27. History or current drug abuse.\n28. Uncontrolled intercurrent illness, or condition or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","ALL","18 Years",{"count":149,"type":150},46,"ESTIMATED","INTERVENTIONAL",[153],"PHASE1","This is an open-label, Phase I\u002FIb trial including an initial dose-escalation phase in patients with advanced solid tumors and a dose-expansion phase at recommended phase 2 dose (RP2D) in combination with Androgen Receptor Pathway Inhibitors (ARPi) in patients with metastatic castration resistant prostate cancer (mCRPC).\n\nThe trial will enroll following a 3+3 design up to 6 patients with any type of solid tumors after progression to standard treatments at each dose level during the dose-escalation phase. Four dose levels are planned. If the first DL is deemed not safe, the next patients could be treated at a lower dose. If further reductions are required, the study will be stopped. After determining the RP2D, the trial will enroll up to 20 additional evaluable patients with mCRPC during the dose-expansion phase. The first six patients enrolled in the dose-expansion phase will be the safety lead in cohort for the combination and will be monitored for DLTs. The rest of patients will be enrolled afterwards at the RP2D if found safe or with a lower ITR-251 dose level if the combination shows unacceptable toxicity.\n\nThe study aims to determine the RP2D of ITR-251 and the safety in combination with ARPi in mCRPC. Secondary objectives includes duration of treatment, tolerability, pharmacokinetics, and preliminary signs of antitumoral activity and efficacy. Pharmacodynamics will be an exploratory objective.",[156,157],"Solid Tumor Cancer","Castration Resistant Metastatic Prostate Cancer","NOT_YET_RECRUITING","2026-10-06",{"date":161,"type":162},"2026-10-13","ACTUAL",{"date":164,"type":150},"2026-10",{"date":166,"type":150},"2029-07",{"name":5,"class":6},1]