[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lomond Therapeutics Holdings, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":87},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"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":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100544277","phase-1-dose-escalation-and-expansion-study-to-evaluate-the-safety-pk-pd-and-efficacy-of-ze46-0134-in-adults-with-flt3-mutated-or-spliceosome-mutated-relapsed-or-refractory-acute-myeloid-leukemia-100544277",false,"NCT06366789","Dose Escalation and Expansion Study to Evaluate the Safety, PK, PD and Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia","A Phase 1, Open-label, Dose Escalation and Dose Expansion, Multicenter Clinical Trial to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ZE46-0134 in Adults With FLT3 Mutated or Spliceosome Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Group 1: Patient must have a confirmed FLT3-ITD or FLT3-TKD mutation by central laboratory testing. Group 2: Patient must have a documented SF3B1, SRSF2, U2AF1, or ZRSR2 pathogenic mutation by local lab sequencing.\n5. For Group 1 only: Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion Criteria:\n\n1. Written Informed Consent must be obtained from the patient or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).\n2. Patient is ≥18 years of age at the time of obtaining informed consent.\n3. Patient is refractory to or relapsed after first-line AML therapy (with or without HSCT).\n4. Patient must have a confirmed FLT3 ITD, TKD or ITD-F691L mutation documented within the past 90 days in absence of therapy or within the Screening period 28 days) prior to study drug administration on C1D1 if therapy has been given.\n5. Patients must have previously been treated with Gilteritinib with failure to stop disease progression, or not met the criteria for treatment with Gilteritinib in the opinion of the Investigator, or chosen not to have treatment with Gilteritinib for social reasons.\n6. Patients have a life expectancy of at least 3 months in the opinion of the Investigator.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2.\n8. Patient must meet the following criteria as indicated on the clinical laboratory tests:\n\n   1. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN)\n   2. Serum total bilirubin ≤1.5 × ULN unless due to Gilbert's disease\n   3. Estimated glomerular filtration (eGFR) rate of \\>50 mL\u002Fmin as calculated by the Modification of Diet in Renal Disease equation.\n9. Female patients:\n\n   1. If of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the Screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone (FSH) level consistent with postmenopausal status, per local laboratory guidelines), or\n   2. If of childbearing potential, must:\n\n   i. Have a negative serum pregnancy test at the Screening visit and urine pregnancy test on admission to the clinic on Day-1.\n\n   ii. Agree not to attempt to become pregnant or donate ova from signing the consent form until at least 45 days after the last dose of study drug.\n\n   iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception from Screening until at least 45 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle).\n10. Male patients and their female spouse\u002Fpartners who are of childbearing potential must agree to use highly effective contraception consisting of 2 forms of birth control (at least 1of which must be a barrier method) starting at Screening and continue throughout the study period and for 45 days after the final study drug administration. Male patient must not donate sperm starting at Screening and throughout the study period and for 45 days after the final study drug administration.\n\nExclusion criteria\n\n1. Diagnosis of isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML)\n2. Acute promyelocytic leukemia (FAB M3)\n3. Active central nervous system (CNS) involvement by AML\n4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy\n5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy\n6. Disseminated intravascular coagulopathy with active, unmanageable bleeding or signs of thrombosis.\n7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by the local regulatory authority.\n8. Systemic antineoplastic therapy within 5 half-lives or radiation therapy within 1 week prior to starting protocol with the exception of hydroxyurea, which is allowed to control white blood cell counts.\n9. Female patients who are pregnant or lactating\n10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the study.\n11. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin (regular or high sensitivity) leak alone not included if no residual dysfunction), New York Heart Association (NYHA) Class III or IV heart failure, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n12. Infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control in the opinion of the Investigator. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a clinical study aiming to assess pharmacokinetics, pharmacodynamics and preliminary efficacy of ZE46-0134 in patients with FLT3 and spliceosome mutated Relapsed or Refractory Acute Myeloid Leukemia",[26],"AML With Gene Mutations","RECRUITING","2025-12-24",{"date":30,"type":31},"2025-12-31","ACTUAL",{"date":33,"type":31},"2024-05-29",{"date":35,"type":20},"2027-12",{"name":37,"class":38},"Lomond Therapeutics Holdings, Inc.","INDUSTRY",23,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100616288","phase-1-a-phase-1b-study-of-lonitoclax--azacitidine-in-acute-myeloid-leukemia-patients-100616288","NCT07303660","A Phase 1b Study of Lonitoclax + Azacitidine in Acute Myeloid Leukemia Patients","A Phase 1b Study of Lonitoclax + Azacitidine (Aza) in Acute Myeloid Leukemia (AML) Patients","Inclusion Criteria:\n\n1\\. Patients must be able to understand and provide written informed consent. 2. AML patients: For the dose escalation and expansion, patients aged 18 and older with relapsed and\u002For refractory AML would be eligible. Prior treatment with a hypomethylating agent or Venetoclax is allowed.\n\n3\\. At the time of Lonitoclax initiation, white blood count (WBC) needs to be \\\u003C 25 × 109\u002FL: Hydroxyurea can be used to achieve that level.\n\n4\\. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. 5. Adequate organ function as defined by the following:\n\n1. Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 x ULN. AST and\u002For ALT may be up to 5 x ULN if thought to be secondary to leukemia.\n2. Total bilirubin ≤ 1.5 x ULN (patients with known Gilbert's syndrome may enroll if direct bilirubin is ≤ 3 x ULN) for the local laboratory.\n3. Estimated Glomerular Filtration Rate (eGFR) according to the Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI) ≥ 60 mL\u002Fmin\u002F1.73m2 for the local laboratory.\n\n   6\\. Female patients of childbearing potential must agree to use a highly effective method of contraception from screening visit until 120 days following the last dose of study treatment. Highly effective methods of contraception include sexual abstinence, bilateral tubal ligation, tricycle combined (estrogen and progestogen containing) oral or transdermal hormonal contraceptives, intrauterine devices and vasectomized partner. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n\n   7\\. Male patients capable of having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use highly effective contraception from the screening visit until 120 days until the last dose of study treatment, and themselves use barrier contraception (i.e., condoms). They must also refrain from sperm donation from the screening visit until 120 days following the last dose of study treatment. Should his partner become pregnant or suspect she is pregnant while he is participating in this study, he should inform his treating physician immediately.\n\n   8\\. Patients must be able to take oral medications. Exclusion Criteria\n   1. Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML).\n   2. Acute promyelocytic leukemia (FAB M3).\n   3. Active central nervous system (CNS) involvement by AML.\n   4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy.\n   5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n   6. Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n   7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by Regulatory Authorities.\n   8. Systemic antineoplastic therapy within 1 week (or 5 half-lives of drug received, whichever is shorter) or radiation therapy within 1 week prior to starting protocol except for hydroxyurea, which is allowed to control white blood cell counts.\n   9. Female patients who are pregnant or lactating.\n   10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.\n   11. Concomitant medications that are strong CYP3A4 inducers.\n   12. Patients with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications. This does not apply to patients with a pacemaker as measurement of QTc is not accurate under such conditions and bears no risk to patients since they are being medically paced by their device.\n   13. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin leak alone not included if no residual dysfunction), familial QT prolongation, known potassium wasting syndrome (Bartter syndrome, Gitelman syndrome, and Liddle syndrome), New York Heart Association (NYHA) Class III or IV heart failure, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n   14. As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.\n\n   Exclusion Criteria:\n   1. Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML).\n   2. Acute promyelocytic leukemia (FAB M3).\n   3. Active central nervous system (CNS) involvement by AML.\n   4. Clinical signs\u002Fsymptoms of leukostasis requiring urgent therapy.\n   5. Known active infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C. Patients with a history of positive serology for hepatitis B or C require a negative Polymerase chain reaction (PCR) test for virus to go onto therapy.\n   6. Disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n   7. Patients who have received an investigational agent (for any indication) within 5 half-lives of the agent; if the half-life of the agent is unknown, patients must wait 1 week prior to first dose of study treatment. An investigational agent is one for which there is no approved indication by Regulatory Authorities.\n   8. Systemic antineoplastic therapy within 1 week (or 5 half-lives of drug received, whichever is shorter) or radiation therapy within 1 week prior to starting protocol except for hydroxyurea, which is allowed to control white blood cell counts.\n   9. Female patients who are pregnant or lactating.\n   10. Patients with psychological, familial, social, or geographic factors, other significant medical condition, laboratory abnormality that otherwise preclude them from giving informed consent, following the protocol, potentially hamper compliance with study treatment and follow-up or would confound the interpretation of the results of the trial.\n   11. Concomitant medications that are strong CYP3A4 inducers.\n   12. Patients with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications. This does not apply to patients with a pacemaker as measurement of QTc is not accurate under such conditions and bears no risk to patients since they are being medically paced by their device.\n   13. Patients with the following will be excluded: uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, serious cardiac arrhythmia, myocardial infarction with evidence of residual abnormalities within 6 months prior to enrollment (Troponin leak alone not included if no residual dysfunction), familial QT prolongation, known potassium wasting syndrome (Bartter syndrome, Gitelman syndrome, and Liddle syndrome), New York Heart Association (NYHA) Class III or IV heart failure, electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Patients with medical comorbidities that will preclude safety evaluation of the combination should not be enrolled.\n   14. As infection is a common feature of AML, patients with active infection are permitted to enroll provided that the infection is under control. Patients with uncontrolled infection shall not be enrolled until infection is treated and brought under control.",{"count":48,"type":20},66,[23],"This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory Acute Myeloid Leukemia patients.",[52],"Acute Myeloid Leukemia",[52,54],"AML","NOT_YET_RECRUITING","2025-12-18",{"date":58,"type":31},"2025-12-26",{"date":60,"type":20},"2026-01-10",{"date":62,"type":20},"2027-11",{"name":37,"class":38},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},"100570565","phase-1-a-phase-1-study-of-ze50-0134-in-relapsed-and-refractory-chronic-lymphocytic-leukemia-small-lymphocytic-lymphoma-and-select-low-grad-lymphomas-100570565","NCT06708897","A Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, and Select Low-grad Lymphomas","Phase 1 Study of ZE50-0134 in Relapsed and Refractory Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL), and Select Low-grade Lymphomas","Inclusion Criteria:\n\n1. Men and women aged ≥18 years.\n2. Disease as defined below:\n\n   Part 1: Patients with symptomatic CLL or SLL (defined by iwCLL) without del(17p)\u002FTP53 must have received ≥2 prior therapies that have included a BTKi and venetoclax (or declined this) or Patients with progressive low-grade lymphoma that includes marginal zone lymphoma, lymphoplasmacytic lymphoma (including Waldenstrom's macroglobulinemia) who have received at least 2 therapies including a BTKi and CD20 antibody-based therapy.\n\n   Part 2: Patients with symptomatic CLL or SLL (defined by iwCLL) must have received ≥1 prior therapies that have included a BTKi and be venetoclax naive.\n3. Prior to beginning part 2, an activation amendment will be submitted to the FDA that includes safety, pharmacokinetics, pharmacodynamics and early efficacy data from the Part 1 portion. At this time, we may also include cohorts of specific types of low-grade lymphoma as well. Adequate bone marrow, liver, and renal functions as assessed by the following laboratory requirements to be conducted within 7 days before the first dose of study drug:\n\n   * Absolute neutrophil count (ANC) \\> 0.75 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 0.5 x 109\u002FL\n   * Platelet count \\> 50 x 109\u002FL. For subjects with documented bone marrow involvement ≥ 30 x 109\u002FL\n   * Serum aspartate transaminase (AST\u002FSGOT) or alanine transaminase (ALT\u002FSGPT) ≤ 3.0 x upper limit of normal (ULN)\n   * Total bilirubin ≤ 1.5 x ULN\n   * Creatinine or Cystatin C glomerular filtration rate (GFR) ≥60 mL\u002Fmin. Estimated GFR (eGFR) according to the Modification of Diet in Renal Disease Study Group (MDRD) formula and expressed in mL\u002Fmin. To convert mL\u002Fmin\u002F1.73 m2 to mL\u002Fmin multiply by the individual's BSA calculated using an appropriate formula and divide by 1.73 Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less Negative serum or urine pregnancy test must be obtained within 7 days before the first dose of study drug in women of childbearing potential. Negative results must also be available before each cycle.\n\nPostmenopausal women, as defined below, are exempt from pregnancy testing:\n\n* Age \\>50 years with amenorrhea for at least 12 months or\n* Age ≤50 years with 6 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within postmenopausal range (\\>40 mIU\u002FmL) OR\n* Permanently sterilized women (e.g., hysterectomy, bilateral salpingectomy, or uterine ablation) Women and men of reproductive potential must agree to use highly effective contraception when sexually active. This applies for the period between signing of the informed consent and 90 days after the last administration of study drug. These methods should be documented in source documents. The investigator or a designated associate is requested to advise the subject on how to achieve highly effective birth control. Ability to understand and the willingness to sign a written informed consent. A signed informed consent (including consent for genetic biomarker\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they display any of the following criteria:\n\n1. FOR PART 2 ONLY\n\n   \\- No prior venetoclax treatment\n\n   FOR BOTH PARTS ALL THE FOLLOWING APPLY:\n2. Know active Richter's transformation. Patients who have been treated for this diagnosis and have been in remission for \\> 2 years without evidence of this and who have only CLL are considered eligible\n3. Known hypersensitivity to the study drug or excipients of the preparation or any agent given in association with this study.\n4. Clinically significant cardiac disease including congestive heart failure \\> New York Heart Association (NYHA) Class II, evidence for uncontrolled coronary artery disease (e.g., unstable angina (anginal symptoms at rest) or new-onset angina (within the last 6 months or myocardial infarction within the past 6 months before first dose, major regional wall motion abnormalities upon baseline echocardiography), and cardiac arrhythmias requiring anti- arrhythmic therapy except for beta-blockers and digoxin.\n5. Known Active cytomegalovirus (CMV), hepatitis B or C virus infection.\n6. Known Active SARS-CoV-2 infection; prior SARS-CoV-2 infection allowed if completely recovered \\> 14 days.\n7. Active clinically serious infections of Grade \\>2, requiring parenteral therapy; Subjects may be eligible after infection resolves.\n8. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within 28 days of enrolment.\n9. Allogeneic bone marrow transplant within 4 months before first dose of study drug (Subjects must have completed immunosuppressive therapy before enrollment).\n10. Active cancer that limits expected survival to \\\u003C 2 years or requires active therapy concomitant with this treatment. Exclusions would be localized skin cancer, breast cancer, prostate cancer that are resected or malignancies treated with hormonal or immune therapies alone. All cases of secondary cancer should be discussed with the medical monitor.\n11. A physical exam or laboratory finding that contraindicates the use of investigational therapy or otherwise places the subject at excessively high risk for treatment, as determined by the investigator. A discussion between the investigator and sponsor regarding eligibility is encouraged for such cases.\n12. Unresolved toxicity of previous treatments (excluding cases of alopecia) Grade ≥2.\n13. Requires ongoing immunosuppressive therapy, including systemic (e.g., intravenous or oral) corticosteroids for the treatment of cancer or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (≤10 mg of prednisone or equivalent per day) as therapy for comorbid conditions. Short courses of steroids before first dose are allowed for tumor flare.\n14. Major surgery or significant trauma within 4 weeks before the first dose of study drug.\n15. Breastfeeding women: breastfeeding women have to discontinue breastfeeding before onset of and during treatment and should be discontinued for at least 3 months after end of treatment.\n16. Subjects with QTcF \\> 470 msec that cannot be corrected with electrolyte replacement, hydration, or medication modifications.",{"count":48,"type":20},[23],"This is a clinical study aiming to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ZE50-0134 in relapsed and refractory chronic lymphocytic leukemia, small lymphocytic lymphoma, and select low-grad lymphomas.",[75,76,77],"CLL \u002F SLL","CLL (Chronic Lymphocytic Leukemia)","SLL (Small Lymphocytic Lymphoma)","2025-11-28",{"date":80,"type":31},"2025-12-05",{"date":82,"type":31},"2025-04-08",{"date":84,"type":20},"2028-04",{"name":37,"class":38},4,""]