[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607585":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":93,"collaborators":19,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":19,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":19,"enrollmentInfo":104,"targetDuration":19,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"ProteinQure Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PQ203","EXPERIMENTAL","A Phase 1, first-in-human (FIH), multiple ascending dose study of the peptide drug-conjugate PQ203 to evaluate the safety, pharmacokinetics, tolerability and preliminary anti-cancer activity in patients with advanced cancers with solid tumors. Comprises up to 7 planned ascending dose cohorts with expansion of doses to identify recommended dose levels for testing in the Phase 1B Dose Optimization study. This is an open label study and all participants will receive PQ203.",[13],"Drug: PQ203",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","PQ203 is a peptide drug-conjugate given once weekly by intravenous infusion intended for the treatment of advanced solid tumor cancers including triple negative breast cancer.",[9],null,[21,44,59,74],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"MD Anderson Cancer Center","RECRUITING","Houston","Texas","77030","United States","US",{"type":30,"coordinates":31},"Point",[32,33],-95.36327,29.76328,{"lat":33,"lon":32},[36,41],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Desirae Dufner","CONTACT","713-745-7813","DDufner@mdanderson.org",{"name":42,"role":43,"phone":19,"phoneExt":19,"email":19},"Timothy A Yap, MBBS, PhD, FRCP","PRINCIPAL_INVESTIGATOR",{"facility":45,"status":23,"city":46,"state":25,"zip":47,"country":27,"countryCode":28,"cosmosGeoPoint":48,"geoPoint":52,"contacts":53},"NEXT Oncology","San Antonio","78229",{"type":30,"coordinates":49},[50,51],-98.49363,29.42412,{"lat":51,"lon":50},[54,57],{"name":55,"role":38,"phone":56,"phoneExt":19,"email":55},"nxt_txreferrals@nextoncology.com","210-580-9500",{"name":58,"role":43,"phone":19,"phoneExt":19,"email":19},"David Sommerhalder, MD",{"facility":60,"status":23,"city":61,"state":62,"zip":63,"country":27,"countryCode":28,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"START Mountain Region","West Valley City","Utah","84119",{"type":30,"coordinates":65},[66,67],-112.00105,40.69161,{"lat":67,"lon":66},[70],{"name":71,"role":38,"phone":72,"phoneExt":19,"email":73},"Olivia Darais","801-917-4750","olivia.darais@startresearch.com",{"facility":75,"status":23,"city":76,"state":77,"zip":78,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Princess Margaret Cancer Centre","Toronto","Ontario","M5G 0C6","Canada","CA",{"type":30,"coordinates":82},[83,84],-79.39864,43.70643,{"lat":84,"lon":83},[87,91],{"name":88,"role":38,"phone":89,"phoneExt":19,"email":90},"Clinical Cancer Research Unit","416-946-4559","patientrelations@uhn.ca",{"name":92,"role":43,"phone":19,"phoneExt":19,"email":19},"Philippe Bedard, MD",{"type":94,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","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":105,"type":106},80,"ESTIMATED","INTERVENTIONAL",[109],"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.",[112,113],"Triple Negative Breast Cancer (TNBC)","Advanced Solid Tumors Cancer",[115,116,9,117,118],"Triple Negative Breast Cancer","TNBC","advanced solid tumors","Phase 1","2026-02-19",{"date":121,"type":122},"2026-02-23","ACTUAL",{"date":124,"type":122},"2025-09-16",{"date":126,"type":106},"2029-02",{"name":5,"class":6},4]