[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597863":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":58,"centralContacts":63,"locations":71,"responsibleParty":88,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":50,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":50,"enrollmentInfo":104,"targetDuration":50,"studyType":107,"phases":108,"briefSummary":111,"conditions":112,"keywords":50,"overallStatus":73,"whyStopped":50,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of California, Irvine","OTHER",[8,14,20,24,28,32,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1b Dose Level 1 - Spedox-6","EXPERIMENTAL","Spedox-6, 20 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.",[13],"Drug: Spedox-6",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1b Dose Level 2 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 40 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],"Drug: Pegfilgrastim","Drug: Filgrastim",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 1b Dose Level 3 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 80 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],{"label":25,"type":10,"description":26,"interventionNames":27},"Phase 1b Dose Level 4 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 120 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],{"label":29,"type":10,"description":30,"interventionNames":31},"Phase 1b Dose Level 5 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 160 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],{"label":33,"type":10,"description":34,"interventionNames":35},"Phase 1b Dose Level 6 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 200 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],{"label":37,"type":10,"description":38,"interventionNames":39},"Phase 1b Dose Level 7 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 250 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],{"label":41,"type":10,"description":42,"interventionNames":43},"Phase 1b Dose Level 8 - Spedox-6 + Filgrastim\u002FPegfilgrastim","Spedox-6, 310 mg\u002Fm2, Chemotherapy single agent systemic, received on day 1 of each 21 day cycle, for a total of 6 cycles.\n\nFilgrastim or Pegfilgrastin, injected subcutaneously or intravenously, received according to Institutional standard.",[13,18,19],[45,51,55],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Spedox-6","Given Intravenously (IV)",[9,15,21,25,29,33,37,41],null,{"type":46,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"Pegfilgrastim","Given Subcutaneous Injection or IV",[15,21,25,29,33,37,41],{"type":46,"name":56,"description":53,"armGroupLabels":57,"otherNames":50},"Filgrastim",[15,21,25,29,33,37,41],[59],{"name":60,"affiliation":61,"role":62},"Warren Chow, MD","Chao Family Comprehensive Cancer Center","PRINCIPAL_INVESTIGATOR",[64,69],{"name":65,"role":66,"phone":67,"phoneExt":50,"email":68},"Chao Family Comprehensive Cancer Center University of California, Irvine","CONTACT","1-877-827-8839","ucstudy@uci.edu",{"name":70,"role":66,"phone":50,"phoneExt":50,"email":50},"University of California Irvine Medical Center",[72],{"facility":65,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Orange","California","92868","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-117.85311,33.78779,{"lat":83,"lon":82},[86],{"name":60,"role":66,"phone":87,"phoneExt":50,"email":68},"877-827-8839",{"type":62,"investigatorFullName":89,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":50,"oldOrganization":50},"Warren Chow","Professor - Division of Hematology-Oncology, Department of Medicine, UCI School of Medicine",[92],{"name":93,"class":94},"Sunstate Biosciences LLC","INDUSTRY","100597863","phase-1-trial-of-single-protein-encapsulated-doxorubicin-spedox-6-in-advanced-malignancies-100597863",false,"NCT07064018","Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies","Phase Ib\u002FIIa Trial of Single Protein Encapsulated Doxorubicin, SPEDOX-6 in Advanced Malignancies","Inclusion Criteria:\n\n* Subjects ≥ 18 years at the first screening examination\u002Fvisit.\n* Subjects with advanced histologically or cytologically confirmed solid tumors (see below) refractory to or relapse from at least two previous therapies.\n* Tumor types expected to express lower levels of FcRn relative to normal tissue including: STS, TNBC, cervical cancer, NSCLC, ovarian cancer, and KRAS mutated pancreatic ductal adenocarcinoma without requirement for testing FcRn level.\n* Disease that is considered measurable by RECIST v1.1.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n* Life expectancy of at least 12 weeks.\n* Human Immunodeficiency Virus (HIV)-positive trial participants should be on established antiretroviral therapy (ART) for at least four weeks and have an HIV viral load less than 400 copies\u002FmL prior to enrollment.\n* Left ventricular ejection fraction \\> 50%.\n* Adequate organ function: (Hb ≥10 g\u002FdL, ANC ≥1,000\u002FµL3, and platelets\n\n  ≥100,000\u002FµL3), serum bilirubin ≤.5x the institutional upper limit of normal (ULN) (unless known Gilbert's disease), Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3x ULN, and creatinine clearance \\>50 mL\u002Fmin as assessed by Cockcroft-Gault equation.\n* For patients with known Gilbert's disease, serum unconjugated bilirubin must be \\\u003C 4 mg\u002FdL.\n* Patient must have washed out of prior chemotherapy (at least 3 weeks from last end of therapy), radiotherapy (at least 4 weeks from last end of therapy), immunotherapy (at least 4 weeks from last end of therapy), other targeted therapies (at least 4 weeks from last end of therapy), or surgery (at least 4 weeks).\n* Recovery from toxicities of prior therapy. Toxicities should have recovered to CTCAE grade ≤ 1 or baseline with exception of alopecia.\n* Females of reproductive potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment. Additionally, female subjects of reproductive potential should agree to use effective acceptable forms of contraception: surgical sterilization (tubal ligation); total abstinence from sexual intercourse with the opposite sex; established hormonal birth control (e.g., oral, transdermal, injection, or implant) plus a barrier method or a double barrier method (intrauterine device, spermicide, or a diaphragm plus condom) for at least 1 month prior to Cycle 1 Day 1 and agreement to use such a method during study participation and for an additional 6 months after the last dose of SPEDOX-6.\n* For males of reproductive potential: vasectomy or highly effective contraception (e.g., condoms, abstinence) during the study and for an additional 6 months after the last dose of SPEDOX-6.\n\nExclusion Criteria:\n\n* Patients with cancers with known driver mutations for which there are known and effective targeted therapies that have not received those therapies, but are able to. If a patient has received appropriate targeted treatment for their mutations and progressed, or those treatments are contraindicated, they will be considered potentially eligible.\n* Unstable angina pectoris, angioplasty, cardiac stenting, or myocardial infarction 6 months before study entry.\n* Untreated metastases to the Central Nervous System (CNS).\n* Have received any prior doxorubicin or anthracycline equivalent.\n* Previous radiation to the mediastinal or pericardial area.\n* A known allergy to albumin.\n* HIV infection with CD4+ count \\\u003C 350 cells\u002FµL or Acquired Immunodeficiency (AIDS)-defining opportunistic infection in previous 12 months.\n* Pregnant (positive serum or urine pregnancy test) or lactating.\n* Previous treatment with an investigational agent or the non-approved use of a drug or device withing 4 weeks of study entry.\n* Uncontrolled diabetes mellitus.\n* Patients who require concomitant use of strong inhibitors or inducers of CYP3A4, CYP2D6 or P-glycoprotein (P-gp).","ALL","18 Years",{"count":105,"type":106},67,"ESTIMATED","INTERVENTIONAL",[109,110],"PHASE1","PHASE2","This is a Phase 1b\u002FIIa dose escalation clinical trial determining the recommended phase II dose of SPEDOX-6 in subjects with advanced, therapy-refractory soft-tissue sarcoma (STS); triple-negative breast cancer (TNBC); Non-small cell lung cancer (NSCLC); cervical cancer; ovarian cancer; KRAS mutant pancreatic ductal adenocarcinoma. These are subjects who have not previously been treated with anthracyclines.",[113,114,115,116,117,118],"Soft-tissue Sarcoma","Triple Negative Breast Cancer","Non-small Cell Lung Cancer","Cervical Cancer","Ovarian Cancer","KRAS Mutation-Related Tumors","2025-07-02",{"date":121,"type":122},"2025-07-14","ACTUAL",{"date":124,"type":122},"2025-04-30",{"date":126,"type":106},"2031-12-31",{"name":5,"class":6},1]