[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619216":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":32,"locations":38,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":92,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Second Life Therapeutics","INDUSTRY",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"SL-28 Low Dose","EXPERIMENTAL",null,[13],"Biological: SL-28",{"label":15,"type":10,"description":11,"interventionNames":16},"SL-28 Intermediate Dose",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SL-28 High Dose",[13],[21,26,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BIOLOGICAL","SL-28","Doses administered: 3×10\\^7 cells\u002Finjection, once daily, 5 days per week, 12 weeks.\n\nMode of administration: intravenous push",[9],{"type":22,"name":23,"description":27,"armGroupLabels":28,"otherNames":11},"Doses administered: 6×10\\^7 cells\u002Finjection, once daily, 5 days per week, 12 weeks.\n\nMode of administration: intravenous push",[15],{"type":22,"name":23,"description":30,"armGroupLabels":31,"otherNames":11},"Doses administered: to-be-determeined-later Mode of administration: intravenous push",[18],[33],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"George Tetz, MD, PhD","CONTACT","16466173088","clinical@secondlifetx.com",[39],{"facility":40,"status":11,"city":41,"state":42,"zip":11,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Hollywood Private Hospital","Nedlands","Western Australia","Australia","AU",{"type":46,"coordinates":47},"Point",[48,49],115.8073,-31.98184,{"lat":49,"lon":48},[52],{"name":53,"role":35,"phone":11,"phoneExt":11,"email":11},"Adnan Khattak",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100619216","phase-1-sl-28-for-advanced-solid-tumours-100619216",false,"NCT07341737","SL-28 for Advanced Solid Tumours","A Phase 1\u002F2, Multicentre, Open-Label, Dose Escalation and Expansion Study to Assess the Safety, Pharmacokinetics, and Preliminary Efficacy of SL-28 in Patients With Advanced Solid Tumours","Inclusion Criteria:\n\n* Ability to provide written informed consent prior to any study-related procedures and to understand the nature, purpose, and potential risks of the study\n* Adult males and females ≥18 years of age at screening\n* Life expectancy of at least 3 months\n* Histologically or cytologically confirmed unresectable advanced solid tumor (recurrent, metastatic, or locally advanced)\n* Disease refractory to, intolerant of, or refusal of standard therapies, including immunotherapy and molecular\u002Fbiomarker-directed treatments, as determined by the Principal Investigator (PI) or delegate\n* Eligible tumor types include:\n* Head and neck squamous cell carcinoma\n* Thoracic malignancies (small-cell lung cancer, non-small cell lung cancer, esophageal cancer)\n* Gastrointestinal malignancies (gastric, liver, colorectal, pancreatic adenocarcinoma)\n* Genitourinary malignancies (bladder, renal cell, prostate cancer)\n* Gynecologic malignancies (ovarian, endometrial cancer)\n* Breast cancer and melanoma\n* Evaluable disease per RECIST v1.1\n* ECOG performance status 0-1 (or up to 2 at PI discretion)\n* Adequate organ function, defined as:\n* Total bilirubin ≤1.5 × ULN (≤2.0 × ULN for liver metastases or Gilbert's syndrome)\n* AST, ALT, alkaline phosphatase ≤2.5 × ULN (≤5 × ULN if liver metastases, at PI discretion)\n* Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault) or eGFR ≥50 mL\u002Fmin (CKD-EPI)\n* Absolute neutrophil count ≥1,000\u002Fmm³\n* Platelet count ≥100,000\u002Fmm³\n* Hemoglobin ≥90 g\u002FL without transfusion within 2 weeks\n* Prothrombin time and aPTT ≤1.5 × ULN (or stable INR if on anticoagulation)\n\nFemale patients:\n\n-Non-childbearing potential (surgically sterile or postmenopausal), or of childbearing potential with negative pregnancy tests and agreement to effective contraception through 90 days post-dose\n\nMale patients:\n\n* Agreement not to donate sperm for 90 days post-dose\n* Agreement to use adequate contraception as applicable\n* Suitable venous access for blood sampling\n* Willingness and ability to comply with study procedures and protocol requirements\n\nExclusion Criteria:\n\n* Ongoing toxicities ≥ Grade 2 per NCI CTCAE v5.0 (except alopecia, fatigue, sensory neuropathy, or adequately treated endocrine deficiencies)\n* NYHA Class III or IV heart disease, myocardial infarction within 6 months, unstable arrhythmia, or ischemia on ECG\n* QTcF \\>470 ms (females) or \\>450 ms (males)\n* Active, uncontrolled bacterial, viral, or fungal infection requiring systemic therapy\n* Requirement for systemic corticosteroids or other immunosuppressive therapy that cannot be discontinued ≥14 days prior to dosing\n* Prior therapies within restricted timeframes:\n* Immune checkpoint inhibitors or biologics within 28 days\n* Antineoplastic therapies, surgery, radiotherapy, or radiopharmaceuticals within 21 days\n* Unapproved investigational drugs within 5 half-lives\n* Nitrosoureas or mitomycin C within 6 weeks\n* Concurrent malignancy within 5 years, except specified low-risk cancers\n* Pregnancy or breastfeeding\n* Known HIV, hepatitis B (HBsAg positive), or hepatitis C infection\n* Inability or unwillingness to comply with protocol procedures\n* History of anaphylaxis or significant allergy interfering with participation\n* Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, neurologic, psychiatric, or immunologic disease within 6 months\n* Conditions affecting drug absorption, distribution, metabolism, or excretion\n* Receipt of live vaccines within 28 days prior to screening\n* Participation in another investigational study within 30 days prior to screening","ALL","18 Years",{"count":66,"type":67},60,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","Second Life Therapeutics is developing SL-28, an allogeneic, non-genetically modified cell-based therapy for the treatment of advanced solid tumours. The company has recently demonstrated a novel, non-genetic approach to modulate immune cell activity through targeted manipulation of the Universal Receptive System. The purpose of this open label, multi-center clinical trial is to evaluate the anti-tumor activity, safety, and pharmacokinetics, single-agent SL-28 in patients with a diverse array of solid tumors. The study includes an initial Phase 1 dose escalation to determine recommended dose(s) for expansion of SL-28 as a monotherapy and Phase 2 expansion cohorts. The study will enroll patients with advanced solid tumours, including those who failed previous lines of chemo- and immunotherapies.",[74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"Head & Neck Cancer","Pancreas Carcinoma","Pancreas Cancer, Metastatic","Lung Adenocarcinoma","Lung Cancer (NSCLC)","Lung Cancer (Non-Small Cell)","Esophageal Cancer","Stomach (Gastric) Cancer","Liver Cancer","Intestinal Cancer","Bladder Cancer","Renal Cancer","Prostate Cancer","Melanoma (Skin Cancer)","Breast Cancer","Ovarian Cancer","Endometrial Cancer","Colorectal Cancer","NOT_YET_RECRUITING","2026-01-13",{"date":95,"type":96},"2026-01-15","ACTUAL",{"date":98,"type":67},"2026-02-01",{"date":100,"type":67},"2027-03-01",{"name":5,"class":6},1]