[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ProteinQure Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":47},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100607585","phase-1-pq203-in-advanced-malignant-tumors-including-triple-negative-breast-cancer-100607585",false,"NCT07190469","PQ203 in Advanced Malignant Tumors Including Triple Negative Breast Cancer","A Phase 1, Open-label, Multicenter Clinical Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Anti-Cancer Activity of PQ203 in Patients With Advanced Solid Tumor Malignancies","Inclusion Criteria:\n\n* At least 18 years old\n* Histologically or cytologically documented metastatic or locally advanced solid tumor malignancies having progressed through or being otherwise ineligible to receive approved standard-of-care therapies\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Documented presence of RECIST v1.1 measurable disease\n* Adequate organ function confirmed by the following laboratory values obtained within 14 days of the first dose of PQ203:\n\nBone Marrow Function\n\n* Absolute neutrophil count (ANC) ≥ 1.5 × 10e9\u002FL\n* Platelets \\> 100 × 10e9\u002FL\n* Hemoglobin ≥ 9 g\u002FdL\n\nHepatic Function\n\n* AST, alanine transaminase ALT or ALP ≤ 2.5 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN\n* Bilirubin ≤ 1.5 × ULN (\\\u003C 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome)\n* Serum albumin ≥ 35 g\u002FL (3.5 g\u002FdL)\n\nRenal Function\n\n* Calculated creatinine clearance of ≥ 60 mL\u002Fmin by the Cockcroft-Gault equation\n* Urine protein \\\u003C 2+\n\nCardiac Function\n\n• Left ventricular ejection fraction (LVEF) ≥ 50%\n\nOther\n\n* Understand and voluntarily sign an Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC)\u002FResearch Ethics Board (REB)-approved informed consent form prior to any study-specific evaluation.\n* PT\u002FPTT or INR \\\u003C1.2x upper limit of normal\n* Non-surgically sterile men and women of child bearing potential must agree to use highly effective methods of contraception for at least 4 months beyond the final dose received.\n* Toxicity of previous antitumor therapy has returned to Grade ≤1\n\nExclusion Criteria:\n\n* Patients with primary central nervous system (CNS) malignancies (Patients with stable brain metastases (≥ 4 weeks after a treatment) not requiring steroids or other treatment will be allowed on study).\n* Blood transfusion within 14 days of study treatment\n* Serious comorbid medical conditions such as heart, lung, kidney, liver, and brain disease that, in the opinion of the enrolling investigator, could interfere with study treatment\n* Subjects with history of severe heart disease\n* QTc interval using Fridericia's formula (QTcF) \\> 470 ms\n* Estimated or known weight \\> 115 kg (253 lbs)\n* Known\u002Fsuspected pregnancy and\u002For lactation\n* Diastolic blood pressure \\\u003C 60 mmHg or \\>110 mmHg\n* Uncontrolled intercurrent illness\n* Long term care facility resident or prisoner\n* Any prior receipt of a MMAE-containing drug\n* Any prior receipt of a SORT1-targeting medication\n* Participation in another clinical study investigating a drug or medical device or a neuro-interventional or surgical procedure that is not considered as standard care in the 30 days preceding study enrolment\n* Treatment with any of the following:\n* Chemotherapy or other systemic anti-cancer therapy ≤14 days or 5 half-lives (whichever is shorter) prior to first dose of study drug except for Nitrosoureas or mitomycins ≤42 days\n* Major surgery ≤28 days from first dose of study drug\n* Patients with a history of cerebrovascular accident within 6 months of planned first dose.\n* Patients with clinically symptomatic ocular toxicities\n* Patients with history of (noninfectious) interstitial lung disease (ILD)\u002Fpneumonitis that require steroids, with current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Patients with active Grade \\>1 peripheral neuropathy","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The primary purposes of this study are to determine the safety and tolerability of PQ203 in patients with advanced solid tumors including triple negative breast cancer (TNBC), and to determine a recommended Phase 2 dose level for future studies in TNBC.",[26,27],"Triple Negative Breast Cancer (TNBC)","Advanced Solid Tumors Cancer",[29,30,31,32,33],"Triple Negative Breast Cancer","TNBC","PQ203","advanced solid tumors","Phase 1","RECRUITING","2026-02-19",{"date":37,"type":38},"2026-02-23","ACTUAL",{"date":40,"type":38},"2025-09-16",{"date":42,"type":20},"2029-02",{"name":44,"class":45},"ProteinQure Inc.","INDUSTRY",4,""]