[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nurix Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":226},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,51,82,114,136,163,188],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100609970","phase-2-a-study-of-nx-5948-in-adults-with-cllsll-previously-treated-with-a-brutons-tyrosine-kinase-inhibitor-and-a-b-cell-lymphoma-2-inhibitor-daybreak-cll-201-100609970",false,"NCT07221500","A Study of NX-5948 in Adults With CLL\u002FSLL Previously Treated With a Bruton's Tyrosine Kinase Inhibitor and a B-cell Lymphoma-2 Inhibitor (DAYBreak CLL-201)","A Single-arm, Phase 2, Open-label, Multicenter Study to Evaluate NX-5948 in Adults With Relapsed\u002FRefractory (R\u002FR) Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) Previously Exposed to a Bruton's Tyrosine Kinase Inhibitor (BTKi) and a B-cell Lymphoma-2 Inhibitor (BCL-2i)","Inclusion Criteria:\n\n* Age: ≥ 18 years\n* Confirmed relapsed\u002Frefractory CLL\u002FSLL that meets iwCLL criteria for diagnosis and systemic treatment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Must have received a covalent BTK inhibitor (BTKi), a non-covalent BTKi, and a BCL-2 inhibitor either in separate lines of therapy or in combination; a line of therapy is considered 2 or more consecutive cycles of a systemic anti-CLL\u002FSLL regimen\n* Participants with SLL must have measurable disease by radiographic assessment\n* Adequate organ and bone marrow function\n* Must sign an informed consent form indicating that he or she understands the purpose of the procedures required for the study and is willing to participate\n\nExclusion Criteria:\n\n* Known or suspected prolymphocytic leukemia or Richter's transformation before entering study\n* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) before planned start of study drug\n\n  * Antibody therapy must stop at least 4 weeks before the first dose of study drug\n  * No other systemic anticancer therapy is allowed at the same time as this study; exception: continuation of hormonal therapy for breast and prostate cancer is allowed, if they are not on the list of prohibited concomitant medications in this study\n* Palliative limited-field radiotherapy within 7 days of the first dose of study or broad field radiotherapy within 28 days of first dose of study drug\n* Use of systemic corticosteroids \\>20 mg\u002Fday prednisone or equivalent within the 7 days before start of study drug except for those used as premedication for radio diagnostic contrast\n* Use of systemic immunosuppressive drugs other than systemic corticosteroids within 60 days before the first dose of study drug\n* Previously treated with a BTK degrader\n* Previous chimeric antigen receptor (CAR) T-cell therapy or allogeneic or autologous hematopoietic cell transplant within the past 90 days prior to enrollment\n* Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage within 6 months of planned start of study drug\n\nNote: Other Inclusion\u002FExclusion criteria may apply as defined in the protocol.","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a study for patients with relapsed\u002Frefractory (R\u002FR) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with a BTK inhibitor (covalent and non-covalent) and a BCL-2 inhibitor. The main purpose of this study is to test if NX-5948 (bexobrutideg) works to treat patients with CLL\u002FSLL. Participation could last up to 5 years, and possibly longer, if the disease does not progress.",[26,27],"Chronic Lymphocytic Leukemia (CLL)","Small Lymphocytic Lymphoma (SLL)",[29,30,31,32,33,34,35,36,37,26,27],"BTK Degrader","BTK Inhibitor","BCL-2 Inhibitor","B-cell Malignancy","Lymphoma","Bruton's Tyrosine Kinase","NX-5948","Targeted Protein Degradation","Chimeric Targeting Molecule (CTM)","RECRUITING","2026-06-30",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2025-10-15",{"date":46,"type":20},"2030-10",{"name":48,"class":49},"Nurix Therapeutics, Inc.","INDUSTRY",32,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":75,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100449326","phase-1-a-study-of-nx-5948-in-adults-with-relapsedrefractory-b-cell-malignancies-100449326","NCT05131022","A Study of NX-5948 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Patients in Phase 1a (Dose Escalation) must have histologically confirmed R\u002FR CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.\n* Patients in Phase 1a must meet the following:\n\n  o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy\n* Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and\u002For molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL\u002FSCNSL.\n* Measurable disease per response criteria specific to the malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment\n* Prior treatment for the indication under study for anti-cancer intent that includes:\n\n  1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).\n  2. Prior systemic chemotherapy within 2 weeks of planned start of study drug.\n  3. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.\n  4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.\n  5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.\n  6. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).\n  7. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL\u002FSCNSL: no greater than 40 mg\u002Fday prednisone, or equivalent. Patients with PCNSL\u002FSCNSL using greater than 20 mg\u002Fday prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg\u002Fday prednisone or equivalent.\n  8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n  9. Previously treated with a BTK degrader\n* Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.\n* Patient has any of the following within 6 months of planned start of study drug:\n\n  1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent\n  2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure\n  3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage\n  4. Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical management)\n* Bleeding diathesis, or other known risk for acute blood loss.\n* History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.\n* Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).",{"count":59,"type":20},572,[61],"PHASE1","This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.",[26,27,64,65,66,67,68,69,70],"Diffuse Large B Cell Lymphoma (DLBCL)","Follicular Lymphoma (FL)","Mantle Cell Lymphoma (MCL)","Marginal Zone Lymphoma (MZL)","Waldenstrom Macroglobulinemia (WM)","Primary Central Nervous System Lymphoma (PCNSL)","Secondary Central Nervous System Lymphoma (SCNSL)",[29,30,72,33,73,74,34,35,36,37],"B-Cell Malignancy","C481","C481S",{"date":41,"type":42},{"date":77,"type":42},"2022-04-13",{"date":79,"type":20},"2028-01",{"name":48,"class":49},62,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100632924","phase-1-study-of-nx-5948-in-combination-with-other-agents-in-adults-with-b-cell-malignancies-100632924","NCT07520006","Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","An Open-label, Multicenter Phase 1b\u002F2 Study to Evaluate the Safety and Efficacy of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate organ and bone marrow function\n* Measurable disease by computed tomography (CT) per iwCLL\n* For R\u002FR CLL\u002FSLL, prior therapy must include treatment with a Bruton tyrosine kinase inhibitor (BTKi)\n* For 1L CLL\u002FSLL, confirmed previously untreated CLL\u002FSLL with a clinical indication for systemic treatment that meets iwCLL criteria\n* Must sign an informed consent form indicating understanding of the study purpose and procedures and willingness to participate\n\nKey Exclusion Criteria:\n\n* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment\n* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment\n* Radiotherapy within 2 weeks of the first dose of study drug except for focal palliative radiation\n* Use of systemic corticosteroids (\\>20 mg\u002Fday prednisone or equivalent) within the 7 days prior to initiation of study treatment excepting those used as prophylaxis for radiodiagnostic contrast\n* Previously treated with a BTK degrader\n* Previously treated with a BCL-2 inhibitor (BCL-2i) unless eligible for retreatment\n* Known central nervous system (CNS) lymphoma or leukemia\n* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment\n* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment\n\nNote: Other Inclusion\u002FExclusion criteria may apply as defined in the protocol.",{"count":90,"type":20},150,[61,23],"The study will evaluate NX-5948 (bexobrutideg) in combination with venetoclax with or without an anti-CD20 antibody (rituximab or obinutuzumab) in second-line or higher (2L+) relapsed\u002Frefractory (R\u002FR) or first-line (1L) chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL).",[94,95,96],"B-cell Lymphoma","Chronic Lymphocytic Leukemia","Small Lymphocytic Lymphoma",[26,27,98,99,100,101,102,103,104],"Degrader","B-cell malignancy","BTKi","Bexobrutideg","Venetoclax","Obinutuzumab","Rituximab","NOT_YET_RECRUITING","2026-04-08",{"date":108,"type":42},"2026-04-13",{"date":110,"type":20},"2026-05",{"date":112,"type":20},"2033-05",{"name":48,"class":49},{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":4,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":121,"targetDuration":4,"studyType":21,"phases":123,"briefSummary":125,"conditions":126,"keywords":127,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":4},"100632623","phase-3-study-of-nx-5948-versus-pirtobrutinib-in-rr-cllsll-100632623","NCT07516093","Study of NX-5948 Versus Pirtobrutinib in R\u002FR CLL\u002FSLL","A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed\u002FRefractory (R\u002FR) Chronic Lymphocytic Leukemia (CLL)\u002FSmall Lymphocytic Lymphoma (SLL)","Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate organ and bone marrow function\n* Confirmed diagnosis of CLL\u002FSLL that meets iwCLL 2018 criteria for diagnosis and systemic treatment\n* Received at least one prior line of therapy for CLL\u002FSLL that included a cBTKi and must have documented disease progression during treatment with, or after discontinuation of, the cBTKi\n* Participants with SLL must have measurable disease by computed tomography (CT) per iwCLL\n\nKey Exclusion Criteria:\n\n* Known or suspected prolymphocytic leukemia or Richter's transformation at any time preceding enrollment\n* Investigational agent or anticancer therapy within 5 half-lives or 14 days (whichever is shorter) prior to planned start of study treatment\n* Ongoing systemic corticosteroids ≥10 mg\u002Fday prednisone or equivalent\n* Previously treated with a BTK degrader or a noncovalent BTKi\n* Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, placement of a coronary arterial stent, or any other significant cardiac condition within 6 months of planned start of study treatment\n* Thromboembolic events, stroke, or intracranial hemorrhage within 6 months of planned start of study treatment\n\nNote: Other Inclusion\u002FExclusion criteria may apply as defined in the protocol.",{"count":122,"type":20},620,[124],"PHASE3","The study will evaluate the efficacy and safety of NX-5948 (bexobrutideg) versus pirtobrutinib in participants with relapsed\u002Frefractory (R\u002FR) chronic lymphocytic leukemia (CLL)\u002Fsmall lymphocytic lymphoma (SLL) who are relapsed or refractory to prior covalent Bruton tyrosine kinase inhibitor (cBTKi) treatment.",[94,95,96],[26,27,98,99,100,101,128],"Pirtobrutinib","2026-04-06",{"date":106,"type":42},{"date":132,"type":20},"2026-06",{"date":134,"type":20},"2032-06",{"name":48,"class":49},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100426218","phase-1-a-study-of-nx-2127-in-adults-with-relapsedrefractory-b-cell-malignancies-100426218","NCT04830137","A Study of NX-2127 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, Safety and Tolerability Study of NX-2127, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Inclusion Criteria:\n\n* Patients must be ≥ 18 years of age\n* Patients must have measurable disease per disease-specific response criteria\n* Patients with indolent forms of NHL must meet the criteria requiring systemic treatment (i.e., iwCLL, IWG, Lugano Classification of Lymphoma response criteria, or International PCNSL Collaborative Group response criteria)\n* Patients with transformed lymphoma are eligible for the study with the exception of those detailed in Exclusion Criteria #1: Prolymphocytic leukemia, MCL with blastoid histology, MCL with pleomorphic morphology, or MCL with known TP53 mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (non-PCNSL indications) or 0 - 2 (PCNSL patients)\n* Adequate organ and bone marrow function\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol\n\nInclusion Criteria for Patients in Phase 1a:\n\n* Have histologically confirmed R\u002FR CLL, SLL, WM, MCL, and MZL, FL, DLBCL, or PCNSL\n* Received at least 2 prior systemic therapies (or at least 1 prior therapy for patients with WM or PCNSL) and have no other therapies known to provide clinical benefit\n* Must require systemic therapy\n\nInclusion Criteria for Patients in Phase 1b:\n\n* Must have one of the following histologically documented R\u002FR B-cell malignancies:\n\n  * CLL\u002FSLL whose disease has failed treatment with a BTKi;\n  * MCL whose disease has failed treatment with BTKi and an anti-CD20 mAb-based regimen\n  * FL or MZL whose disease has failed treatment with an anti-CD20 mAb-based regimen; or WM whose disease has failed treatment with a BTKi\n  * PCNSL whose disease failed at least 1 prior line of treatment\n  * DLBCL whose disease has failed treatment with an anti-CD20 mAb-based regimen and either: an anthracycline-based regimen; or an anti-CD19-based regimen, or another\u002F palliative regimen (either progressed post stem cell transplant or transplant-ineligible)\n\nExclusion Criteria:\n\n* Active, uncontrolled autoimmune hemolytic anemia or autoimmune thrombocytopenia\n* History of known\u002Fsuspected other autoimmune disease (exception(s): patients with alopecia, vitiligo, resolved childhood atopic dermatitis, hypothyroidism, or hyperthyroidism that is clinically euthyroid at screening are allowed.)\n* Unable to swallow capsules or have a condition that may interfere in the delivery, absorption, or metabolism of the study drug\n* Bleeding diathesis, or other known risk for acute blood loss\n* Patients requiring ongoing treatment with warfarin or an equivalent vitamin K antagonist and within 7 days prior to the first dose of study drug\n* Prior radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation)\n* Toxicities from previous anticancer therapies must have resolved to baseline levels or to Grade 1 (except for alopecia, hypothyroidism with adequate replacement therapy, hypopituitarism with adequate replacement therapy, peripheral neuropathy or hematologic parameters meeting inclusion criteria).\n* Active known second malignancy. Exception: patients with non-metastatic, non-melanoma skin cancer are eligible\n* Patient has had major surgery (e.g. requiring general anesthesia) within 4 weeks before the planned first dose of study drug\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: patients with well-controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active liver disease from any cause\n* Active viral reactivation (e.g., CMV or EBV)\n* Use of systemic corticosteroids exceeding 20 mg\u002Fday prednisone (or equivalent) for non-PCNSL indications within 15 days prior to the planned start of study drug. PCNSL patients may not exceed corticosteroid doses of 40 mg\u002Fday prednisone (or equivalent) and should be on a stable or decreasing dose for 7 days prior to planned study start.\n* Use of non-steroidal immunosuppressive drugs within 30 days prior to start of the study\n* Clinically significant, uncontrolled cardiac, cardiovascular disease, or history of myocardial infarction within 6 months of planned start of study drug\n* Administration of any strong cytochrome P450 3A (CYP3A) inducers or inhibitors for 14 days prior to the first dose of study drug, and any P-glycoprotein inhibitors (for 2 days) or moderate inducers of CYP3A for 7 days",{"count":144,"type":20},248,[61],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-2127 in patients with advanced B-cell malignancies.",[26,27,68,66,67,65,148,69],"Diffuse Large B-cell Lymphoma (DLBCL)",[29,30,32,33,150,151,152,34,153,36,37,73,74],"IMiD","Lenalidomide","Pomalidomide","NX-2127","2026-03-18",{"date":156,"type":42},"2026-03-20",{"date":158,"type":42},"2021-05-05",{"date":160,"type":20},"2027-05",{"name":48,"class":49},16,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":170,"sex":16,"minAge":171,"maxAge":172,"enrollmentInfo":173,"targetDuration":4,"studyType":21,"phases":175,"briefSummary":176,"conditions":177,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":187},"100571209","phase-1-relative-bioavailability-of-nx-5948-tablets-vs-capsules-and-the-effect-of-covariates-on-the-pk-of-nx-5948-tablets-100571209","NCT06717269","Relative Bioavailability of NX-5948 Tablets vs Capsules and the Effect of Covariates on the PK of NX-5948 Tablets","A Phase 1, Open-Label Study in Healthy Volunteers to Evaluate the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, and the Effect of Food and an Acid-reducing Agent on the Pharmacokinetics of NX-5948","Key Inclusion Criteria:\n\n* Healthy, adult, male or female 19-55 years of age\n* Continuous non-smoker who has not used nicotine and tobacco-containing products for at least 3 months prior to the first dosing\n* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg\u002Fm2\n* Medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, or 12-lead safety ECGs at the screening visit, as deemed by the PI or designee\n* Understands the study procedures in the informed consent form (ICF) and be willing and able to comply with the protocol.\n\nKey Exclusion Criteria:\n\n* Mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study\n* Clinically significant history or presence of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neoplastic myeloproliferative, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine or connective tissue diseases or disorders\n* History of any gastrointestinal surgery or cholecystectomy that could impact the PK of NX-5948\n* History or presence of alcohol or drug abuse within the past 2 years\n* History or presence of hypersensitivity, angioedema, or idiosyncratic reaction to the study drug(s) or related compounds\n* History or presence of:\n\n  * Significant multiple and\u002For severe allergies, including anaphylactic reaction.\n  * Personal or family history of prolonged QT syndrome or family history of sudden cardiac death.\n  * Evidence of atrial fibrillation, atrial flutter, complete bundle branch block, Wolff Parkinson-White Syndrome, or cardiac pacemaker.\n  * Adrenal insufficiency.\n  * Skin infection.\n* Female volunteers of childbearing potential\n* Female volunteer with a positive pregnancy test\n* Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit\n* Donation of blood or significant blood loss within 56 days prior to the first dosing\n* Plasma donation within 7 days prior to the first dosing\n* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n* Previous exposure to NX-5948.\n* Participation in another clinical study within 30 days or within 5 half-lives (if known), prior to the first dosing, whichever is longer. The 30-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of Period 1 of the current study.",true,"19 Years","55 Years",{"count":174,"type":20},18,[61],"This is a multiple part, multiple cohort study evaluating the relative bioavailability, food effect, and drug-drug interaction of NX-5948 in healthy volunteers.",[178],"Healthy Volunteer","2026-02-03",{"date":181,"type":42},"2026-02-05",{"date":183,"type":42},"2024-11-30",{"date":185,"type":20},"2026-08",{"name":48,"class":49},1,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":213,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":225},"100447533","phase-1-a-study-of-nx-1607-in-adults-with-advanced-malignancies-100447533","NCT05107674","A Study of NX-1607 in Adults With Advanced Malignancies","A Phase 1a, Dose Escalation, Safety and Tolerability Study of NX-1607, a Casitas B-lineage Lymphoma Proto-oncogene (CBL-B) Inhibitor, in Adults With Advanced Malignancies, With Phase 1b Expansion in Select Tumor Types","Key Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Measurable disease per disease-specific response criteria.\n* Patients must have disease that is metastatic or unresectable and have received standard treatment options, are not candidates for standard treatment options, or will otherwise be prevented from receiving any standard treatment options.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Minimum of 3 weeks or 5 half-lives (whichever is shorter) since last dose of systemic cancer therapy (unless otherwise specified) or minimum of 2 weeks since last radiotherapy, or minimum of 6 weeks since last systemic therapy with nitrosoureas, antibody-drug conjugate, or radio immuno-conjugate therapy.\n* Adequate organ and bone marrow function, in the absence of growth factors (with limited exception for DLBCL), as defined by laboratory parameters.\n* Patients of child-bearing potential must use adequate contraceptive measures to avoid pregnancy for the duration of the study as defined in the protocol.\n* Patient must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.\n* Each patient must sign an informed consent form (ICF).\n* Histological or cytological diagnosis of platinum-resistant EOC, including primary peritoneal and fallopian tube carcinoma; gastric\u002FGEJ cancer; HNSCC; recurrent and either metastatic or unresectable melanoma; NSCLC; mCRPC; MPM; TNBC; locally advanced or metastatic urothelial cancer; cervical cancer; MSS CRC; or DLBCL (including DLBCL-RT)\n* Accessible tumor (for all cohorts) or lymph node (DLBCL only) for biopsy (Phase 1b only).\n\nKey Exclusion Criteria:\n\n* Active untreated brain metastases.\n* Patient has any of the following:\n* Uncontrolled intercurrent illness including, but not limited to, poorly controlled hypertension or diabetes, or ongoing active infection requiring systemic therapy.\n* Patients with primary refractory EOC defined as patients who do not respond to their first platinum-containing regimen or who relapse less than 6 months after completion of that first platinum-containing regimen\n* Psychiatric illness that would limit compliance with study requirements.\n* Treatment with any of the following prior to the first dose of NX-1607: CPI (anti-PD-1, PD-L1, cytotoxic T-lymphocyte-associated protein 4, etc) within 3 weeks; autologous or allogeneic stem cell transplant within 100 days; prior systemic cancer therapy within 3 weeks or 5 half-lives (whichever is shorter) (unless otherwise specified) (including hormonal therapy except for hormonal prophylaxis for a prior malignancy); prior radiotherapy within 2 weeks; prior systemic therapy with nitrosoureas, antibody-drug conjugate, or radio-immuno-conjugate therapy within 6 weeks; use of strong or moderate CYP3A4 inducers or inhibitors within 14 days or 7 days, respectively, or 5 half-lives (whichever is longer)\n* History of CAR-T therapy within 30 days prior to the first dose of NX-1607.\n* Toxicities from previous anti-cancer therapies that have not resolved to baseline levels or to Grade 1 or less except for Grade 2 alopecia and Grade 2 peripheral neuropathy or patients receiving endocrine replacement therapy\n* Patients who experienced Grade 3 or higher irAEs with prior immunotherapy.\n* History of uveitis, or an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Unable to swallow capsules or has malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction likely to interfere with the delivery, absorption, or metabolism of NX-1607.\n* Known allergies, hypersensitivity, or intolerance to components of NX-1607.\n* Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of NX-1607.\n* Patient is a man who plans to father a child while enrolled in this study or within 3 months after the last dose of NX-1607 and, as applicable, within 6 months after the last dose of paclitaxel.\n* Patient has had major surgery (e.g., requiring general anesthesia) within 4 weeks before the planned first dose of NX-1607, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 4 weeks after the last dose of NX-1607. Note: Patients with minor planned surgical procedures to be conducted under local anesthesia may participate.\n* Vaccinated with a live vaccine within 28 days (with the exception of the annual inactivated influenza vaccine) or COVID-19 vaccination within 14 days prior to the first dose of NX-1607.\n* Active known second malignancy with the exception of any of the following:\n\n  * Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer.\n  * Adequately treated Stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years.\n  * Low-risk prostate cancer with Gleason score \\\u003C 7 and PSA \\\u003C 10 ng\u002FmL.\n  * Any other cancer from which the patient has been disease-free for ≥ 2 years.\n* Infection with human immunodeficiency virus (HIV)-1 or HIV-2. Exception: Patients with well controlled HIV (e.g., CD4 \\> 350\u002Fmm3 and undetectable viral load) are eligible.\n* Current active hepatitis, including hepatitis A (hepatitis A virus immunoglobulin M \\[IgM\\] positive), hepatitis B (hepatitis B virus \\[HBV\\] surface antigen positive), or hepatitis C (hepatitis C virus \\[HCV\\] antibody positive, confirmed by HCV RNA). Patients with HCV with undetectable virus after treatment are eligible. Patients with prior exposure to HBV may be entered if quantitative PCR is negative.\n* Use of systemic corticosteroids (\\> 20 mg prednisone or equivalent) within 15 days (except for prophylaxis for radio diagnostic contrast reactions and\u002For prophylaxis for patients receiving paclitaxel), or other immunosuppressive drugs within 30 days, prior to the first dose of NX-1607.\n* Use of biotin (i.e., Vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 µg \\[NIH 2020\\] (Note: Patients who switch from a high dose to a dose of 30 µg\u002Fday or less at least 1 day prior to Screening assessments are eligible for study entry).\n* Receipt of an IP or has been treated with an investigational device within 3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NX-1607.\n* Any of the following within 6 months prior to the first dose of NX-1607 or ongoing:\n\n  * Myocardial infarction\n  * Unstable angina\n  * Unstable symptomatic ischemic heart disease\n  * New York Heart Association Class III or IV heart failure\n  * Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events)\n  * Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease)\n  * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating Investigator in consultation with the Medical Monitor.",{"count":196,"type":20},345,[61],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.",[200,201,202,203,204,205,206,207,208,209,210,64,211,212],"Ovarian Cancer, Epithelial","Gastric Cancer","GastroEsophageal Junction (GEJ) Cancer","Head and Neck Squamous Cell Carcinoma","Metastatic or Unresectable Melanoma","Non-small Cell Lung Cancer (NSCLC)","Metastatic Castration-resistant Prostate Cancer (mCRPC)","Malignant Pleural Mesothelioma (MPM)","Triple Negative Breast Cancer (TNBC)","Metastatic Urothelial Carcinoma","Cervical Cancer","Richter Transformation","Microsatellite Stable Colorectal Carcinoma",[214,215,216],"Ubiquitin Ligase Inhibitor","Advanced Malignancies","T-cell Activation","2025-09-05",{"date":219,"type":42},"2025-09-09",{"date":221,"type":42},"2021-09-29",{"date":223,"type":20},"2028-02-28",{"name":48,"class":49},17,""]