[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514542":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":31,"collaborators":24,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":24,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":24,"enrollmentInfo":42,"targetDuration":24,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":24,"overallStatus":51,"whyStopped":24,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":24},{"fullName":5,"class":6},"Salarius Pharmaceuticals, LLC","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","For part 1 dose escalation, one patient per dose cohort will be initially recruited (accelerated titration dose-escalation, single-patient cohorts\u002Fdose level) for the first two dose levels or until the first instance of a ≥ Grade 2 toxicity (excluding Grade 2 neutropenia and lymphopenia and adverse events unequivocally due to the underlying disease or to an extraneous cause), or dose-limiting toxicity (DLT), whichever occurs earlier. Further cohorts will be recruited in blocks of three patients, i.e., 3+3 dose escalation design.",[13],"Drug: SP-3164",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose Optimization","For part 2 dose selection optimization, two dose levels will be selected by the Safety Review Committee (SRC) based on review of all available data on safety, tolerability, PK, PD, and preliminary efficacy from part 1. The dose selection optimization will include only patients with R\u002FR DLBCL and will randomize 1:1 approximately 30 new patients at the two selected dose levels (15 patients to each of the two selected dose levels) before declaring the RP2D. Assessment of PK\u002FPD of SP-3164 will be included in part 2 dose selection optimization.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","SP-3164","SP-3164, an oral next generation cereblon-binding molecular glue 'protein degrader'",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Rebecca Griffith-Eskew","CONTACT","+1 254 265 2782","reskew@salariuspharma.com",{"type":32,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100514542","early-phase-1-study-of-sp-3164-in-relapsed-or-refractory-non-hodgkins-lymphoma-100514542",false,"NCT05979857","Study of SP-3164 in Relapsed or Refractory Non-Hodgkin's Lymphoma","A Phase 1, Open-label, Multicenter, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SP-3164 in Patients With Relapsed\u002FRefractory Non-Hodgkin's Lymphoma","Inclusion Criteria:\n\nDiagnosis (WHO 2016 criteria) of R\u002FR B-cell NHL in dose escalation (part 1) and limited to R\u002FR DLBCL in dose selection optimization (part 2) confirmed by biopsy and immunophenotyping\n\nDose escalation: at time of enrollment, R\u002FR B-cell NHL patients per WHO 2016 criteria including DLBCL (including low grade transformed lymphoma), mantle cell lymphoma, follicular lymphoma, and marginal zone lymphoma and must:\n\n* require treatment in the opinion of the Investigator\n* received at least 2 lines of systemic therapy for B-cell NHL\n\nDose selection optimization: at time of enrollment, R\u002FR DLBCL (including low grade transformed lymphoma) patients must have received 2 or 3 lines of systemic therapy for DLBCL\n\no Prior immunomodulatory imide drug (IMiD) therapy is allowed (e.g., lenalidomide)\n\nMeasurable disease per the 2017 International Working Group Consensus Response Evaluation Criteria for Lymphoma\n\nEastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n\nExisting archival tumor tissue (fresh frozen paraffin embedded \\[FFPE\\], 5 unstained slides) not older than 2 years from Cycle 1 Day 1 or willingness to provide fresh tumor biopsy during screening\n\nNormal organ and marrow function, defined by specific laboratory parameters\n\nAbility to take orally administered medication\n\nWashout period prior to Cycle 1 Day 1 of SP-3164: at least 21 days or 5 half-lives (whichever is shorter) from prior systemic anticancer treatment, including chemotherapy, biologic therapy, small molecule inhibitors, monoclonal antibodies, and any investigational agents; at least 14 days from palliative radiotherapy if ≤ 10 fractions or total dose ≤ 30 gray (Gy) or at least 28 days from radiotherapy if total dose \\> 30 Gy; at least 21 days from major surgery\n\nLife expectancy of at least 3 months\n\nExclusion Criteria:\n\nPatients with chronic lymphocytic leukemia, high grade B-cell lymphoma, or Richter's syndrome\n\nPatients who have not recovered to Grade 1 toxicity or baseline due to any previous anticancer therapy according to the NCI CTCAE v5.0, excluding Grade 2 alopecia. Lymphopenia ≤ Grade 2 is allowed\n\nPatients with primary central nervous system (CNS) lymphoma or active CNS or meningeal lymphomatous involvement\n\nPersistent diarrhea or malabsorption of ≥ Grade 2 despite medical management\n\nImpaired cardiac function or clinically significant cardiac disease, including symptomatic congestive heart failure, left ventricular ejection fraction (LVEF) \\\u003C 50%, unstable angina pectoris or cardiac arrhythmias, baseline QTc (Fridericia) \\> 450 milliseconds, long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, myocardial infarct within 6 months of study enrollment, clinically significant pericardial disease\n\nSolid organ transplant recipient\n\nAllogeneic stem cell transplantation (SCT) recipient\n\nAutologous SCT recipient \\\u003C100 days from Cycle 1 Day 1 or otherwise not fully recovered from SCT-related toxicity\n\nCompletion of CAR-T therapy \\\u003C 90 days from Cycle 1 Day 1\n\nSystemic immunosuppressants and chronic systemic corticosteroids (at doses ≥ 10 mg\u002Fday of prednisone or equivalent) are prohibited\n\nMalignant disease, other than that being treated in this study. Note: Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) who have undergone potentially curative therapy are not excluded. Other exceptions include malignancies that were treated curatively and have not recurred within 3 years prior to Cycle 1 Day 1 and any malignancy considered indolent and that has never required therapy\n\nOther concurrent severe or uncontrolled concomitant medical conditions that might cause unacceptable safety risks or compromise compliance with the protocol\n\nPregnant and breastfeeding women\n\nKnown history of HIV-positivity; known hepatitis B or hepatitis C virus infection\n\nMen and women of child-bearing potential unwilling to use adequate contraception according to study protocol","ALL","18 Years",{"count":43,"type":44},72,"ESTIMATED","INTERVENTIONAL",[47],"EARLY_PHASE1","The purpose of this research is to help researchers find out if SP-3164 is safe and if it may be of benefit in the treatment of patients with Non-Hodgkin's lymphoma that has progressed after prior treatment, or that never responded to previous treatment.",[50],"Lymphoma, Non-Hodgkin's, Adult","NOT_YET_RECRUITING","2023-11-20",{"date":54,"type":55},"2023-11-22","ACTUAL",{"date":57,"type":44},"2024-03-15",{"date":59,"type":44},"2027-08-15",{"name":5,"class":6}]