[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"PharmaEngine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,46,69],{"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":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100590933","phase-1-a-study-of-pep08-in-patients-with-mtap-del-advanced-or-metastatic-solid-tumors-100590933",false,"NCT06973863","A Study of PEP08 in Patients With MTAP-Del Advanced or Metastatic Solid Tumors","A Phase 1a\u002F1b Study Evaluating the Clinical Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor Efficacy of PEP08 as Monotherapy and Combination Therapy in MTAP-Del Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Participants must be adults (≥18 years) and sign informed consent before undergoing any study-related procedures.\n* Eligible participants must have advanced or metastatic solid tumors that are not treatable with surgery or radiation, and show evidence of MTAP gene homozygous deletion or MTAP protein loss based on tumor tissue analysis.\n* Participants must have previously received standard treatment for their cancer type, and either experienced disease progression, be refractory, or be intolerant to such therapies.\n* At least one measurable lesion is required, evaluated by standard imaging criteria (RECIST v1.1).\n* Good general physical condition (ECOG performance status 0-1 for dose escalation; broader range allowed for other parts).\n* Adequate function in key organs.\n* Able to swallow oral medication and comply with study requirements.\n* Women of childbearing potential and men with reproductive potential must use effective contraception during and after the study.\n\nExclusion Criteria:\n\n* Recent cancer treatment, immunotherapy, or investigational drugs are not allowed before starting the study.\n* Live vaccines received shortly before treatment are not allowed.\n* Previous use of drugs with similar mechanisms to the study treatment is not allowed.\n* Active or unstable brain or meningeal metastases, unless previously treated and stable without needing local treatment or high-dose steroids.\n* History of other cancers within the last 2 years, unless low-risk and treated (e.g., in situ or certain skin cancers).\n* Uncontrolled disease-related complications (e.g., abnormal calcium levels, fluid buildup around organs).\n* Active HIV, hepatitis B or C infections that are not well-controlled.\n* Ongoing serious infections or systemic conditions requiring isolation.\n* Significant heart disease, such as recent heart failure, ischemia, or arrhythmias.\n* History of severe digestive conditions or surgeries affecting drug absorption.\n* Recent major surgery.\n* Unresolved serious side effects from prior cancer treatment.\n* Currently pregnant or breastfeeding.\n* Poorly controlled blood pressure or lung conditions.\n* Other serious illnesses (e.g., severe anemia, psychiatric or social issues affecting study compliance).\n* Any condition that may pose a safety risk or interfere with the study, as judged by the investigator.\n* Known drug or substance abuse that may affect study participation.\n* Allergy to the study drug or any of its components.","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This is a first-in-human clinical study of PEP08, a novel cancer therapy being evaluated both as monotherapy and in combination with other treatments in patients with advanced or metastatic solid tumors harboring MTAP deletion.\n\nThe study will be conducted in three parts, with Part 1 currently open for enrollment.\n\nThe primary objectives of the study are to:\n\n* Evaluate the safety and tolerability of PEP08, PK and PD\n* Determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D)\n* Assess preliminary signs of anti-tumor activity of PEP08\n\nKey study questions include:\n\n* What is the recommended dose of PEP08 for further development?\n* Wht is the tolerable dose of PEP08 when administered alone or in combination?\n* Does PEP08 show early evidence of clinical activity in patients with MTAP-deleted tumors?\n\nParticipants in the study will:\n\n* Receive PEP08 alone or in combination with another anti-cancer agent, depending on the study part\n* Attend regular clinic visits for treatment administration, laboratory assessments, and tumor evaluations\n* Be enrolled in one of the following study phases over time:\n* \\- Part 1: Monotherapy dose escalation (currently enrolling).\n* \\- Parts 2 and 3 (monotherapy extension and combination therapy) will be activated in future protocol amendments.",[26,27,28,29],"Advanced Solid Tumor","Solid Tumors","MTAP-deleted Solid Tumors","MTAP Deletion",[31,32],"MTAP-del","PRMT5 inhibitor","RECRUITING","2026-02-10",{"date":36,"type":37},"2026-02-13","ACTUAL",{"date":39,"type":37},"2025-08-26",{"date":41,"type":20},"2028-03",{"name":43,"class":44},"PharmaEngine","INDUSTRY",4,{"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":56,"conditions":57,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100489946","phase-1-a-study-of-pep07-checkpoint-kinase-1-inhibitor-in-patients-with-advanced-cancer-100489946","NCT05659732","A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer","A Phase 1b Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer","Inclusion Criteria:\n\n1. Must be ≥ 18 years of age.\n2. Must have histological or cytological confirmation advanced hematologic malignancy including:\n\n   * Relapsed or refractory AML (by the 5th edition of World Health Organization \\[WHO\\] classification of Hematolymphoid tumors)\n   * OR Relapsed or refractory MCL and have received at least two prior lines of treatment, including chemoimmunotherapy and BTKi and at least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma.\n3. Must have Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.\n4. Must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.\n5. Must have adequate liver function as demonstrated by:\n\n   * aspartate aminotransferase (AST) ≤ 2.5 × ULN\n   * alanine aminotransferase (ALT) ≤ 2.5 × ULN\n   * bilirubin ≤ 1.5 × ULN (unless considered due to leukemic organ involvement. Patients with Gilbert's Syndrome may have had a bilirubin \\> 1.5 × ULN per discussion between the PI or designee and sponsor)\n6. Left ventricular ejection fraction (LVEF) ≥ 50% measured by multiple-gated acquisition (MUGA) or echocardiogram.\n7. Previous AEs have been improved to baseline or Grade ≤ 1 NCI CTCAE v5.0.\n8. Female patients with reproductive potential must have a negative serum pregnancy test 7 days prior to the administration of PEP07.\n9. Patients will be required to have a Covid negative test either via reverse transcriptase polymerase chain reaction (RTPCR) or a rapid antigen test (RAT) test on Day -7\u002FDay 1.\n10. Provision of signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females\n2. Females of childbearing potential and males whose partners are of childbearing potential who do not agree to the use of 2 forms of highly effective contraception during the treatment period and for 120 days after the last dose of PEP07.\n3. Patients who have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter), or immunotherapy within 30 days prior to the first dose of PEP07. Patients who have received hydroxyurea or dexamethasone at any time prior to the start of study treatment is an exception to this criterion.\n4. Patients who have undergone allogeneic hematopoietic stem cell transplant (HSCT) within 60 days of PEP07 treatment.\n5. Patients who have received strong or moderate CYP3A4 inhibitors or inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the initiation of study treatment.\n6. Viral infection with HIV or viral hepatitis type B or C which require antiviral therapy and\u002For have positive serology test of hepatitis B surface antigen \\[HBsAg (+)\\] with HBV DNA ≥ 1000 IU\u002FmL, or hepatitis C virus antibody \\[anti-HCV Ab (+)\\] with HCV RNA (+). If a patient is HBsAg (+) then HBV DNA needs to be tested. If a patient is anti-HCV Ab (+) then the patient needs to be followed for HCV RNA (-) to be enrolled.\n7. Uncontrolled systemic infection \u002For requiring isolation.\n8. Patients with previous history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer, in-situ carcinoma of the uterine cervix or myelodysplastic syndromes).\n9. Patients with ongoing ≥ Grade 2 (CTCAE v5.0) toxicity (except alopecia and hot flashes) related to previous treatment.\n10. Patients with baseline QTc interval \\> 450 msec (i.e., CTCAE Grade ≥ 2) at screening (within 28 days prior to 1st dose of PEP07, mean of triplicate readings within approximately 5 minutes).\n11. Patients with cardiovascular disability status of New York Heart Association (NYHA) ≥ Class III, left ventricular ejection fraction \\\u003C 45 % at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment.\n12. Patients who have undergone any major surgery within 3 weeks prior to first study drug administration after enrollment.\n13. Patients with known active central nervous system (CNS) or leptomeningeal involvement.\n14. Patients who have had any of the following within 6 months prior to first administration of PEP07 after enrollment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or seizure disorder.\n15. Have a history of hypersensitivity reactions or allergic reactions to PEP07 excipients and components.\n16. Patients with other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the patient's participation in the trial or interfere with the interpretation of trial results.\n17. Others who are ineligible to participate in this clinical study as determined by the PI or designee.",{"count":54,"type":20},32,[23],"The goal of this clinical trial is\n\n* To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with Acute Myeloid Leukemia (AML) and Mantle Cell Lymphoma (MCL).\n* To determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of PEP07 monotherapy.\n\nParticipants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, HSCT or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.",[58,59],"Acute Myeloid Leukemia","Lymphoma, Mantle-Cell","2025-07-28",{"date":62,"type":37},"2025-07-31",{"date":64,"type":37},"2023-07-17",{"date":66,"type":20},"2026-12-31",{"name":43,"class":44},5,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":21,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":5},"100514824","phase-1-a-study-of-pep07-checkpoint-kinase-1-inhibitor-in-patients-with-advanced-or-metastatic-solid-tumors-100514824","NCT05983523","A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors","A Phase I Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients with Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n1\\. Subjects must be ≥ 20 years of age\n\n2a. For subject in the dose escalation stage: Subjects with advanced or metastatic solid tumors who have failed on or are intolerant to standard treatment or have no access to standard treatment.\n\n2b. For subject in the dose expansion stage: Subjects with histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, who have failed on or are intolerant to standard treatment or have no access to standard treatment.\n\n3\\. At least one measurable lesion according to the RECIST version 1.1.\n\n4\\. Subjects must have ECOG Performance score of 0-1.\n\n5\\. Subject must have adequate renal function as demonstrated by a calculated creatinine clearance ≥ 50 mL\u002Fmin; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula.\n\n6\\. Subject must have adequate liver function as demonstrated by:\n\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN (≤ 5 × ULN, if attributable to liver metastases)\n* Bilirubin ≤ 1.5 × ULN\n\n  7\\. Subject must have adequate bone marrow function as demonstrated by:\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm3\n* Platelet counts ≥ 100,000\u002Fmm3\n* Hemoglobin ≥ 9 g\u002FdL\n\n  8\\. Female subjects with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose of study treatment. Women of childbearing potential as well as males of reproductive potential must agree to refrain from unprotected sex and ensure highly effective contraception with partner during study period and until 6 months after the last dose of study drug.\n\n  9\\. Provision of signed and dated informed consent form.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females.\n2. Subjects have received anti-cancer therapy including chemotherapy, radiotherapy, hormonal or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) or immunotherapy within 30 days prior to the first dose of study treatment.\n3. Subjects have received strong or moderated cytochrome P450 3A4 (CYP3A4) inhibitors or CYP inducers such as ketoconazole, erythromycin, netupitant, isavuconazole etc. within 5 half-lives or 7 days (whichever is the shortest) prior to the first dose of study treatment.\n4. Known history of or positive screening result for human immunodeficiency virus (HIV) antibody.\n5. Viral hepatitis type B or C which require antiviral therapy, and\u002For have HBsAg (+) with HBV DNA ≥ 1000 IU\u002FmL, or anti-HCV Ab (+) with HCV RNA (+). If a patient with HBsAg (+) then HBV DNA needs to be tested. If a patient with anti-HCV Ab (+) then the patient needs to be followed for HCV RNA (-) to be enrolled.\n6. Uncontrolled systemic infection \u002For requiring isolation.\n7. Patients with previous history of other malignant diseases within the last 5 years (other than adequately treated non-melanotic skin cancer, in-situ carcinoma of the uterine cervix or myelodysplastic syndromes).\n8. Subjects with ongoing ≥ Grade 2 (CTCAE v5.0) toxicity (except alopecia and hot flashes) related to previous treatment.\n9. Subjects have baseline QTcF interval \\> 450 msec at screening (within 28 days prior to the first dose of study treatment, mean of triplicate readings within approximately 5 minutes).\n10. Subjects have cardiovascular disability status of New York Heart Association (NYHA) ≥ Class III, left ventricular ejection fraction \\\u003C 45% at baseline, history of cardiac ischemia within the past 6 months, or prior history of cardiac arrhythmia requiring treatment.\n11. Subjects have undergone any major surgery within 3 weeks prior to the first dose of study treatment.\n12. Subjects with known active central nervous system (CNS) or leptomeningeal metastases. Subjects with previously-treated brain or meningeal metastases may participate and be eligible for treatment provided they are stable and asymptomatic (without evidence of progression by imaging of the brain at least 4 weeks prior to the first dose of study treatment), and are not using excessive steroids (defined as a prednisolone dose ≤ 10 mg daily or equivalent) for at least 2 weeks prior to the first dose of study treatment.\n13. Subjects have had any of the following within 6 months prior to the first dose of study treatment: myocardial infarction, severe\u002Funstable angina pectoris, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or seizure disorder.\n14. Subjects have any other medical or psychiatric condition that, in the opinion of the investigator, might interfere with the subject's participation in the trial or interfere with the interpretation of trial results.","20 Years",{"count":78,"type":20},54,[23],"The goal of this clinical trial is To establish the safety profile and determine the dose-limited toxicity (DLT) of PEP07 monotherapy in patients with advanced or metastatic solid tumors. To determine the maximum tolerated dose (MTD) and\u002For recommended Phase 2 dose (RP2D) of PEP07 monotherapy.\n\nParticipants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.",[26,82],"Metastatic Solid Tumor",[84],"Checkpoint Kinase 1 Inhibitor","2024-11-05",{"date":87,"type":37},"2024-11-07",{"date":89,"type":37},"2024-03-27",{"date":91,"type":20},"2027-08-31",{"name":43,"class":44},""]