[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-solid-tumors-that-are-mtap-deficient\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-solid-tumors-that-are-mtap-deficient":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100053708","phase-1-a-study-of-azd3470-a-prmt5-inhibitor-given-as-monotherapy-and-in-combination-in-patients-with-mtap-deficient-advancedmetastatic-solid-tumors-100053708",false,"NCT06130553","A Study of AZD3470, a PRMT5 Inhibitor, Given as Monotherapy and in Combination in Patients With MTAP Deficient Advanced\u002FMetastatic Solid Tumors","PRIMROSE: A Modular Phase I\u002FIIa, Multi-centre, Dose Escalation, and Expansion Study of AZD3470, a MTA Cooperative PRMT5 Inhibitor, as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced\u002FMetastatic Solid Tumors That Are MTAP Deficient","PRIMROSE","Inclusion Criteria (All Modules) Participants are ≥ 18 years (or the legal age of consent in the jurisdiction) at the time of signing the informed consent form.\n\nParticipants are able to provide written informed consent and are willing and able to comply with study procedures.\n\nParticipants are willing to provide archival and\u002For newly obtained (baseline) tumor tissue for central testing, including required biomarker assessment(s) (and any module-specific biomarker requirements).\n\nParticipants have tumors meeting the protocol-defined MTAP-deficiency requirement, based on acceptable prior testing and\u002For central testing per protocol.\n\nParticipants have received prior systemic therapy appropriate for the tumor type and disease stage and have disease progression on or after prior therapy; participants must have had ≥ 1 prior line of systemic treatment in the recurrent\u002Fmetastatic (advanced) setting.\n\nParticipants have ECOG performance status 0-1. Participants have life expectancy ≥ 12 weeks, in the opinion of the Investigator.\n\nParticipants have measurable disease per RECIST v1.1. Participants have adequate organ and bone marrow function per protocol-defined laboratory\u002Fassessment criteria.\n\nParticipants have a treatment-free interval ≥ 3 weeks from prior anticancer therapy before starting study drug (with any additional protocol-defined washout requirements for certain therapies\u002Fprocedures).\n\nContraception use by men and women is consistent with local regulations and protocol-defined requirements.\n\nAdditional Inclusion Criteria (Module 2: Non-squamous NSCLC) Participants have histologically or cytologically confirmed non-squamous NSCLC, Stage IIIB\u002FIIIC not amenable to curative therapy or Stage IV.\n\nParticipants have documented radiographic extracranial disease progression while on or after the most recent treatment regimen for advanced\u002Fmetastatic NSCLC (CNS-only progression is not eligible).\n\nNSCLC of mixed histology is allowed if not predominantly squamous; no small cell or large cell neuroendocrine components.\n\nParticipants meet one of the following:\n\nTumor has a documented EGFR alteration eligible for EGFR-directed therapy (per protocol-defined criteria) and the participant has received prior systemic therapy appropriate for EGFR-altered advanced\u002Fmetastatic NSCLC (per protocol), OR Tumor is negative for EGFR alterations eligible for EGFR-directed therapy, has no other known actionable genomic alterations for which locally approved\u002Favailable targeted therapies exist (per protocol-defined criteria), meets any additional protocol-required biomarker criteria for this cohort (as applicable), and the participant has received prior systemic therapy appropriate for non-actionable-alteration advanced\u002Fmetastatic NSCLC (per protocol).\n\nExclusion Criteria (All Modules) Participants have spinal cord compression, or symptomatic and unstable brain metastases, leptomeningeal disease, or primary CNS malignancy. Participants with asymptomatic, radiographically stable brain metastases who do not require steroids (or who have completed definitive therapy and are neurologically stable off steroids, per protocol) may be eligible.\n\nParticipants have a history of allogeneic organ transplantation. Participants have any clinically significant abnormal laboratory finding or severe and uncontrolled medical condition that, in the Investigator's opinion, makes participation unsafe, including active infection requiring systemic treatment.\n\nParticipants have clinically significant cardiovascular disease or risk factors (including reduced LVEF, cardiomyopathy, clinically active cardiovascular disease, recent major ischemic events or revascularization procedures, uncontrolled angina, severe valvular disease, uncontrolled hypertension, clinically significant heart failure, or recent stroke\u002FTA clinically significant ECG abnormalities, prolonged QTc, or conditions\u002Fmedications that increase risk of QTc prolongation or arrhythmic events)..\n\nParticipants require therapeutic anticoagulation for treatment of acute thromboembolic events, per protocol.\n\nParticipants have active hepatitis B or hepatitis C infection (including detectable viral load, per protocol-defined testing).\n\nParticipants have known HIV infection. Participants have current ILD\u002Fpneumonitis, or a history of (non-infectious) ILD\u002Fpneumonitis requiring systemic steroids or supplemental oxygen, or suspected ILD\u002Fpneumonitis that cannot be ruled out by screening imaging.\n\nParticipants have active gastrointestinal disease, malabsorption, or other GI condition\u002Fsurgery that would significantly interfere with oral drug absorption or tolerability.\n\nParticipants have a history of another primary malignancy. Participants have unresolved clinically significant toxicity from prior anticancer therapy (typically Grade ≥ 2).\n\nParticipants have had prior treatment with a PRMT5 inhibitor Participants are pregnant, breastfeeding, or intend to become pregnant during study participation.\n\nAdditional Exclusion Criteria (Module 2 Only) Participants have inaccessible veins and\u002For inability to place required venous access (e.g., port), per Investigator judgment.\n\nParticipants have contraindication to required CNS imaging (brain MRI preferred or CT with contrast).\n\nParticipants have clinically significant corneal disease. Participants have known active tuberculosis infection, per clinical evaluation and local practice.\n\nParticipants have significant third-space fluid (e.g., pleural effusion\u002Fascites) not amenable to required repeated drainage, per Investigator judgment.\n\nParticipants have severe pulmonary function compromise due to intercurrent pulmonary illness (e.g., severe COPD\u002Fasthma\u002Frestrictive lung disease, recent pulmonary embolism), per protocol.\n\nParticipants have recent radiotherapy that does not meet protocol-defined washout requirements and\u002For ongoing radiation-related toxicities requiring corticosteroids.\n\nParticipants have had prior treatment with protocol-prohibited anticancer therapies.","ALL","18 Years",{"count":20,"type":21},334,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This is a first time in human (FTiH) Phase I\u002FIIa, open-label, multi-centre study of AZD3470 in participants with advanced or metastatic solid tumors with MTAP deficiency. The study consists of several study modules, evaluating the safety, tolerability, pharmacokinetic (PK), pharmacodynamics, and preliminary efficacy of AZD3470 as monotherapy or in combination with other anti-cancer agents.",[28],"Advanced Solid Tumors That Are MTAP Deficient",[30,31],"solid tumor","MTAP deficient","RECRUITING","2026-07-10",{"date":35,"type":36},"2026-07-13","ACTUAL",{"date":38,"type":36},"2024-01-18",{"date":40,"type":21},"2028-12-04",{"name":42,"class":43},"AstraZeneca","INDUSTRY",21,{"id":46,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":22,"phases":48,"briefSummary":26,"conditions":49,"keywords":50,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":54,"completionDateStruct":55,"leadSponsor":56,"locationsCount":44},"100526116",{"count":20,"type":21},[24,25],[28],[30,31],"2026-06-10",{"date":53,"type":36},"2026-06-11",{"date":38,"type":36},{"date":40,"type":21},{"name":42,"class":43}]