[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100467069":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":32,"collaborators":31,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":31,"eligibilityCriteria":40,"healthyVolunteers":36,"sex":41,"minAge":42,"maxAge":31,"enrollmentInfo":43,"targetDuration":31,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":56,"overallStatus":59,"whyStopped":31,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":31},{"fullName":5,"class":6},"Sorrento Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"STI-1386","EXPERIMENTAL","A dose-escalation standard 3+3 design will be utilized and a total of 3 dosing cohorts are planned, receiving up to 4 mL of 1 x 10\\^6 \u002F 1 mL, 1 x 10\\^7 \u002F 1 mL, or 1 x 10\\^8 \u002F 1 mL.",[13],"Drug: STI-1386",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Second generation oncolytic virus",[9],[20],"Seprehvec",[22],{"name":23,"affiliation":5,"role":24},"Mike Royal, MD","STUDY_DIRECTOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","858-203-4100","4146","mroyal@sorrentotherapeutics.com",null,{"type":33,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100467069","phase-1-study-to-assess-the-safety-and-preliminary-efficacy-of-sti-1386-oncolytic-virus-in-relapsed-or-refractory-solid-tumors-100467069",false,"NCT05361954","Study to Assess the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Relapsed or Refractory Solid Tumors","A Phase 1b, Dose-Escalation Study of the Safety and Preliminary Efficacy of STI-1386 Oncolytic Virus in Patients With Relapsed or Refractory Solid Tumors","Inclusion Criteria:\n\n* Histologically confirmed extracranial solid tumors that are relapsing or refractory including locally advanced pancreatic cancer, unresectable soft tissue sarcomas, hepatic metastases due to colorectal cancer\n* At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1) with a non-nodal lesion with longest diameter ≥ 10 mm or nodal lesions with short diameter ≥ 15 mm\n* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2\n* As assessed by the investigator, ≥ 3 month life expectancy\n* Adequate hematologic, liver and renal function at Screening as determined by lab criteria\n* Recovered \\\u003C Grade 2 from all acute toxicities from previous therapy\n* Has not had prior treatment with high dose corticosteroids within the 2 weeks of screening\n* Is willing and able to comply with the study schedule and other protocol requirements\n* Willing to follow contraception guidelines\n\nExclusion Criteria:\n\n* Have a primary brain tumor\n* Use of an investigational drug or local therapy or agent within 2 weeks of first dose of study drug. Current systemic chemotherapy per investigator's discretion is allowed, but no immune checkpoint inhibitors or immune modulators\n* Use of anticoagulants or anti-platelet agents unless subject can safely start\u002Fstop to allow intratumoral injections\n* Use of bevacizumab (Avastin) within 28 days of the STI-1386 injection\n* Diagnosis of other malignancies that have required therapy in the last year or are not in complete remission. Exceptions include non-metastatic basal cell or squamous cell carcinomas of the skin, prostate cancer or cancer in situ that does not require treatment currently or is otherwise under control\n* Requiring chronic systemic immunosuppressants, including steroids \\> 20 mg\u002Fday\n* Presence of bulky disease defined as any single mass \\> 5 cm in greatest dimension will trigger a discussion to determine eligibility\n* New York Heart Association (NYHA) Class \\>3 of left ventricular ejection fraction (LVEF) \\\u003C 50%\n* Prolonged corrected QT interval as determined by 12-lead electrocardiogram\n* Has spinal cord compression or clinically unstable brain metastases within 4 weeks of first dose of study drug\n* Evidence of active herpes infection and\u002For chronic herpes infection requiring prophylactic antiviral medication that may not be discontinued\n* Has an active or recent COVID-19 infection, must have a negative RT-PCR test and not have had symptoms within 4 weeks of day 1 of study drug administration\n* Any active infection requiring systemic therapy within 72 hours of injection of STI-1386, excluding anti-viral maintenance therapy for HIV\n* Moderate to severe chronic obstructive pulmonary disease or other moderate to severe chronic respiratory conditions unless under treatment and stable for the 3 months of screening\n* Have active human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia\n* Pregnant or lactating or up to 3 months post last dose\n* Underlying medical conditions that, in the opinion of the investigator and\u002For medical monitor will prevent the subject from participating\n* Allergy to acyclovir and related anti-HSV antiviral agents","ALL","18 Years",{"count":44,"type":45},36,"ESTIMATED","INTERVENTIONAL",[48],"PHASE1","This is a Phase 1b study to assess the safety and tolerability of STI-1386, an oncolytic virus, in subjects with relapsed and refractory solid tumors (RRSTs).",[51,52,53,54,55],"Cancer","Cancer of Pancreas","Sarcoma","Hepatic Metastasis","Solid Tumor",[51,57,58],"solid tumor","hepatic metastasis","NOT_YET_RECRUITING","2023-04-10",{"date":62,"type":63},"2023-04-12","ACTUAL",{"date":65,"type":45},"2023-08",{"date":67,"type":45},"2027-02",{"name":5,"class":6}]