[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Curis, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":90},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100613828","phase-2-a-study-of-emavusertib--an-approved-bruton-tyrosine-kinase-inhibitor-btki-in-participants-with-chronic-lymphocytic-leukemia-cll-and-other-b-cell-malignancies-100613828",false,"NCT07271667","A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies","A Phase 2 Study of Emavusertib in Combination With an Approved Bruton Tyrosine Kinase Inhibitor in Patients With Chronic Lymphocytic Leukemia and Other B-cell Malignancies","Inclusion Criteria (All Parts):\n\n1. Males and females ≥ 18 years of age.\n2. Life expectancy of ≥ 3 months.\n3. Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2.\n4. Histopathologically confirmed diagnosis of CLL (medical record is acceptable), as per the World Health Organization 2016 classification.\n5. At least 1 criterion for measurable disease per International Workshop on Chronic Lymphocytic Leukemia (iwCLL).\n6. For Cohort 1 only:\n\n   1. Participant must be in a partial response (PR) or partial response with lymphocytosis (PR-L) and measurable residual disease positive (MRD+) per Hallek et al, (2018) criteria.\n   2. Participant must have detectable measurable residual disease (MRD) as determined by the ClonoSEQ assay\n   3. Must be actively taking zanubrutinib for at least 12 months.\n   4. Acceptable organ function at Screening within 28 days prior to Cycle 1 Day 1 (C1D1)\n7. For Cohort 2 only:\n\n   1. Relapsed disease for which participants are ineligible for or have exhausted standard therapeutic options that would be considered standard of care\n   2. Must be actively taking zanubrutinib.\n   3. Participants must have had direct progression on zanubrutinib (within 3 months prior to study entry; administered as monotherapy or in combination) and no other anticancer therapy administered since.\n   4. Acceptable organ function at Screening within 28 days prior to C1D1.\n8. Creatine phosphokinase (CPK) \\\u003C 2.5 × ULN.\n9. Ability to tolerate a contrast-enhanced computed tomography (CT) scan.\n10. Ability to swallow and retain oral medications.\n11. Negative serum pregnancy test in women of childbearing potential (WOCP).\n12. WOCP and men who partner with WOCP must agree to use highly effective contraceptive methods for the duration of the study and for 180 days after the last dose of study treatment.\n13. Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria (All Parts):\n\n1. Active second malignancy unless in remission with a life expectancy of \\> 2 years and with documented Sponsor approval.\n2. Active malignancy other than CLL requiring systemic therapy (exceptions may be granted following a discussion with the Sponsor Medical Monitor).\n3. Have high-risk CLL TP53 mutations and 17P deletion.\n4. History of Grade ≥ 3 rhabdomyolysis without complete recovery.\n5. Received prior chimeric antigen receptor-T cell therapy.\n6. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to C1D1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to C1D1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing uptitration of immunosuppressive medications prior to Screening.\n7. Any prior systemic anticancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 21 days or 5 half-lives, whichever is shorter, prior to C1D1 (with the exception of zanubrutinib, which may be continued until the day before C1D1).\n8. Receiving the following medications within 7 days or 5 half-lives, whichever is shorter, prior to C1D1:\n\n   1. Medications that, in the opinion of the Investigator, have a high risk of causing prolonged QT interval, corrected (QTc) and\u002For Torsades de Pointes.\n   2. Peg-filgrastim or equivalent.\n   3. St John's Wort.\n9. History of or ongoing drug-induced pneumonitis.\n10. History of stroke or intracranial hemorrhage within 6 months prior to C1D1. Participants with post-biopsy hemorrhagic sequela defined as a small hyperdense lesion \\\u003C 3 millimeters (mm) on T2 sequence will not be excluded.\n11. Requirement for anticoagulation with warfarin or equivalent vitamin K antagonists, including dual antiplatelet agents, within 5 half-lives of the anticoagulant or 7 days, whichever is longer, prior to C1D1. Low molecular weight heparin is allowed. Participants who require the use of antiplatelet agents should be discussed with the Sponsor Medical Monitor (e.g., use of factor Xa inhibitors).\n12. Vaccinated with a live-attenuated vaccine within 4 weeks prior to C1D1.\n13. Prior history of hypersensitivity or anaphylaxis to emavusertib, zanubrutinib, or any of their excipients.\n14. Prior history of Stevens-Johnson syndrome or toxic epidermal necrolysis.\n15. Intolerance to contrast-enhanced CT scan due to allergic reactions to contrast agents.\n16. Major surgery \\\u003C 28 days prior to C1D1; minor surgery \\\u003C 7 days prior to C1D1.\n17. Viral infections:\n\n    1. Known to be human immunodeficiency virus (HIV) positive or have an acquired immunodeficiency syndrome (AIDS)-related illness. If HIV is undetectable or maintained on treatment, enrollment may be allowed after discussion with the Sponsor Medical Monitor.\n    2. Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive or hepatitis C virus (HCV) infection \\\u003C 6 months prior to C1D1, unless viral load is undetectable, or HCV with cirrhosis.\n    3. Active systemic infection, including HIV, cytomegalovirus infection, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, or has had, within 28 days prior to C1D1, an infection (other than nail trichophytosis) that requires hospitalization or an intravenous antibiotic.\n18. Concomitant illness that would preclude safe participation in the study.\n19. Pregnant or lactating female.","ALL","18 Years",{"count":19,"type":20},108,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary objective of the study for Cohort 1 and Cohort 2 is to assess the anticancer activity of emavusertib in combination with zanubrutinib in participants with CLL.",[26,27],"Chronic Lymphocytic Leukemia","B-cell Malignancies",[29,30,27,26,31,32],"Emavusertib","BTKi","CLL","Zanubrutinib","RECRUITING","2026-06-11",{"date":36,"type":37},"2026-06-12","ACTUAL",{"date":39,"type":37},"2026-04-23",{"date":41,"type":20},"2027-11",{"name":43,"class":44},"Curis, Inc.","INDUSTRY",11,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},"100310953","phase-1-ca-4948-101-open-label-dose-escalation-and-expansion-trial-of-emavusertib-ca-4948-in-relapsed-or-refractory-primary-central-nervous-system-lymphoma-rr-pcnsl-100310953","NCT03328078","CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R\u002FR PCNSL)","An Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of Orally Administered CA-4948 in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma","Inclusion Criteria:\n\n1. Males and females greater than or equal to 18 years of age\n2. Life expectancy of at least 3 months\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2\n4. Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL.\n\n   1. Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion \\[≥ 10 millimeters (mm) and ≤ 40 mm in the longest diameter on brain magnetic resonance imaging \\[MRI\\] or head computed tomography \\[CT\\] on imaging within 28 days prior to Cycle 1 Day 1\\]). In cases where the tumor size is smaller but still measurable and located at a critical central nervous system (CNS) location, disabling the participant and\u002For causing symptoms, this participant may be eligible following a discussion with the Sponsor Medical Monitor.\n   2. For participants limited to leptomeningeal involvement, cerebrospinal fluid (CSF) analysis (cytology and\u002For flow cytometry) with or without additional imaging (MRI) of the spine as clinically indicated is required to document abnormal cells within 28 days prior to Cycle 1 Day 1.\n\nExclusion Criteria for Part B and Part C\n\n1. Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma metastatic to the CNS\n2. Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the chest, abdomen, and pelvis at Screening (testicular ultrasound may be considered to exclude a testicular lymphoma disseminated to the brain).\n3. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) or prior history of systemic lymphoma, unless the participant has been free of the disease for ≥ 3 years.\n4. Active malignancy other than PCNSL requiring systemic therapy\n5. Previous BTKi treatment (Part C only).\n6. History of Grade ≥ 3 rhabdomyolysis without complete recovery\n7. Requirement for urgent therapy due to uncontrolled tumor mass\u002Fedema effects.\n8. Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1.\n9. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to Cycle 1 Day 1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing up-titration of immunosuppressive medications prior to Screening (with the exception of a BTKi for Part B only).\n\n   Note: The use of a stable or tapering dose of immunosuppressive therapy post-HSCT and\u002For topical steroids for ongoing skin GVHD is permitted with Sponsor Medical Monitor approval\n10. Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1)\n11. Prior history of hypersensitivity or anaphylaxis to emavusertib, ibrutinib or any of their excipients.",{"count":54,"type":20},152,[56,23],"PHASE1","This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R\u002FR) hematologic malignancies.\n\nThis trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete).\n\nPart B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R\u002FR primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles.\n\nPart C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R\u002FR PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R\u002FR PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.",[59,60,61,62],"Relapsed Hematologic Malignancy","Refractory Hematologic Malignancy","Relapsed Primary Central Nervous System Lymphoma","Refractory Primary Central Nervous System Lymphoma",[64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80],"MYD88","IRAK4","NHL","PCNSL","Lymphoma","Neoplasms","Lymphoproliferative Disorders","Lymphatic Diseases","Immunoproliferative Disorders","Immune System Diseases","Lymphoma, Non-Hodgkin","Relapsed\u002Frefractory Central Nervous System (CNS) Lymphoma","Systemic Lymphoma with Concurrent CNS Lymphoma","Systemic Lymphoma with a History of Treated CNS Lymphoma","Ibrutinib","Bruton tyrosine kinase inhibitor (BTKi)","Primary CNS Lymphoma","2026-04-15",{"date":83,"type":37},"2026-04-16",{"date":85,"type":37},"2017-12-28",{"date":87,"type":20},"2026-10",{"name":43,"class":44},45,""]