[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BeBetter Med Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":243},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,47,79,106,129,151,172,196,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645004","phase-2-a-study-of-bebt-908-in-combination-with-chemotherapy-in-patients-with-previously-untreated-peripheral-t-cell-lymphoma-ptcl-100645004",false,"NCT07676175","A Study of BEBT-908 in Combination With Chemotherapy in Patients With Previously Untreated Peripheral T-Cell Lymphoma (PTCL)","An Open-Label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BEBT-908 Plus CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) in Patients With Previously Untreated Peripheral T-Cell Lymphoma (PTCL), and to Explore the Relationship Between Tumor Biomarkers and the Efficacy and Safety of BEBT-908 Plus CHOP.","Inclusion Criteria:\n\n\\-\n\nParticipants must meet all of the following inclusion criteria:\n\n1. Participants must fully understand the study and voluntarily sign an informed consent form (ICF).\n2. Age 18 to 75 years (inclusive), either sex.\n3. Histologically confirmed peripheral T-cell lymphoma (PTCL), including not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell lymphoma (ALCL) deemed by the investigator to be ineligible for or unable to receive anti-CD30 monoclonal antibody therapy (e.g., brentuximab vedotin) due to economic burden or intolerable toxicity (if ALK-positive, International Prognostic Index \\[IPI\\] score must be ≥2), subcutaneous panniculitis-like T-cell lymphoma (SPTCL), enteropathy-associated T-cell lymphoma (EATL), hepatosplenic T-cell lymphoma (HSTL), and other T-cell lymphomas deemed appropriate for enrollment by the investigator.\n4. No prior systemic anti-PTCL therapy.\n5. Life expectancy \\>6 months.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n7. At least one measurable and evaluable tumor lesion (per Lugano 2014 criteria: nodal lesions must have a longest diameter \\>1.5 cm; extranodal lesions must have a longest diameter \\>1.0 cm).\n8. At screening, laboratory parameters must meet the following standards, unless the investigator determines the abnormality is due to lymphoma (with no corrective or supportive treatment for the following parameters within 2 weeks prior to assessment):\n\nPeripheral Blood: a) Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL (≥1.0×10⁹\u002FL for patients with bone marrow involvement); b) White Blood Cell count (WBC) ≥3.0×10⁹\u002FL (≥2.0×10⁹\u002FL for patients with bone marrow involvement); c) Hemoglobin (HGB) ≥80 g\u002FL; d) Platelet count (PLT) ≥75×10⁹\u002FL (≥50×10⁹\u002FL for patients with bone marrow involvement).\n\nHepatic and Renal Function: a) Serum total bilirubin ≤1.5×Upper Limit of Normal (ULN) (≤3.0×ULN for patients with liver involvement); b) Serum creatinine \\\u003C1.5×ULN; c) Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5×ULN, or ≤5×ULN if the investigator determines the elevation is due to hepatic infiltration.\n\nExclusion Criteria:\n\n\\-\n\nParticipants who meet any of the following exclusion criteria are not eligible for enrollment:\n\n1. History or current diagnosis of immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, or other primary or secondary hematologic disorders that may affect bone marrow function, other than the primary malignancy.\n2. Receipt of transfusion, recombinant human thrombopoietin (rhTPO), erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), or similar treatments within 2 weeks prior to the first dose of study drug.\n3. Active bleeding within 2 months prior to the first dose, or current use of anticoagulant medications (e.g., warfarin, phenprocoumon), or evidence of a clear bleeding tendency as determined by the investigator (e.g., esophageal varices at risk of bleeding, active localized ulcerative lesions, fecal occult blood \\>2+), except for bleeding attributed by the investigator to lymphoma itself (e.g., gastrointestinal bleeding caused by gastrointestinal lymphoma).\n4. Participation in another interventional clinical trial within 3 months prior to the first dose.\n5. PTCL with involvement of special sites such as testis, breast, or ovary; extranodal natural killer\u002FT-cell lymphoma (ENKTL); cutaneous T-cell lymphoma (except subcutaneous panniculitis-like T-cell lymphoma \\[SPTCL\\]); or concurrent hemophagocytic lymphohistiocytosis (HLH).\n6. Receipt of the following treatments within 7 days prior to study entry: drugs known to be strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers, or drugs known to significantly prolong the QT interval.\n7. Major surgery requiring general anesthesia within 4 weeks prior to enrollment, or surgery requiring local\u002Fepidural anesthesia within 2 weeks prior to enrollment with incomplete recovery (excluding bone marrow biopsy or local lymphoid tissue biopsy).\n8. Active infection requiring systemic treatment (oral or intravenous) within 2 weeks prior to the first dose, or imaging findings suggestive of interstitial lung disease (ILD), pulmonary fibrosis, or pneumonia (infectious or non-infectious) requiring treatment: participants receiving prophylactic antibiotic therapy (e.g., for interstitial pneumonia) are eligible for enrollment; participants with patchy changes from old or previously treated lesions, determined by the investigator to not affect lung function and not require treatment, are eligible for enrollment.\n9. Corticosteroid use \\>30 mg\u002Fday prednisone or equivalent for purposes other than lymphoma symptom control; the following permitted scenarios must meet corresponding requirements:\n\n   If currently receiving corticosteroid therapy at ≤30 mg\u002Fday prednisone or equivalent, documented evidence of stable dosing for at least 4 weeks prior to initiation of study drug is required.\n\n   If urgent corticosteroid therapy is needed prior to the first dose to control lymphoma symptoms, prednisone up to 100 mg\u002Fday or equivalent may be used for a maximum of 7 days; however, all tumor assessments must be completed before initiation of corticosteroid therapy.\n10. Mean corrected QT interval (QTc) \\>450 msec (male) or \\>470 msec (female) derived from 3 electrocardiogram (ECG) recordings at rest (repeat testing and averaging of 3 corrected values is required only when the first ECG indicates QTc \\>450 msec \\[male\\] or \\>470 msec \\[female\\]); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmia, or current use of antiarrhythmic drugs or implanted defibrillator for treatment of ventricular arrhythmia.\n11. Inability to discontinue during the study period medications that may cause QT prolongation (e.g., antiarrhythmic drugs).\n12. Tumor invasion of surrounding vital organs or vessels (e.g., heart and pericardium, trachea, esophagus, aorta, superior vena cava) with risk of bleeding, or risk of esophagotracheal fistula or esophagopleural fistula.\n13. Participants with clinically symptomatic pleural effusion, ascites, or pericardial effusion that remains poorly controlled despite repeated treatment.\n14. Comorbid conditions: a) Cerebrovascular accident within 6 months prior to the first dose, or history of deep vein thrombosis (DVT), arterial thrombosis, or pulmonary embolism (PE). b) History of other malignancy within 3 years prior to enrollment that does not meet criteria for clinical cure. Exceptions: locally treatable and cured basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma. c) Concurrent central nervous system (CNS) lymphoma or meningeal involvement, or history of or current CNS disorders including but not limited to: epilepsy, paralysis, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome. d) Poorly controlled diabetes mellitus (random blood glucose ≥11.1 mmol\u002FL despite anti-diabetic treatment, or glycated hemoglobin \\[HbA1c\\] ≥8.5%). e) Uncontrolled hypertension \\[systolic blood pressure (SBP) ≥160 mmHg and\u002For diastolic blood pressure (DBP) ≥100 mmHg despite standard treatment, or history of hypertensive crisis or, hypertensive encephalopathy, or history of cerebrovascular accident\\]. f) Significant cardiac disease \\[including any of the following: 1) congestive heart failure above NYHA Class II (i.e., Class III or IV), unstable angina, symptomatic pericarditis, or myocardial infarction within 6 months prior to the first dose of study drug; 2) arrhythmia requiring treatment, or left ventricular ejection fraction (LVEF) \\\u003C50% at screening; 3) primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, unclassified cardiomyopathy); 4) symptomatic coronary artery disease requiring medication at screening; 5) other cardiovascular diseases deemed by the investigator as inappropriate for enrollment\\]. g) Significant renal or hepatic dysfunction. h) Uncontrolled active hepatitis B or hepatitis C disease \\[clinically significant active infections including hepatitis B virus (HBV) and hepatitis C virus (HCV). Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive with HBV DNA ≥2000 IU\u002FmL (equivalent to 10⁴ copies\u002FmL); (if HBsAg or HBeAg positive with HBV DNA \\\u003C2000 IU\u002FmL, per infectious disease control requirements, the participant must continue entecavir until one year after study completion or as recommended by an infectious disease specialist). Active hepatitis C is defined as: HCV RNA above the lower limit of quantification\\]. i) Human immunodeficiency virus (HIV) positive or syphilis (anti-treponemal antibody \\[Anti-TP\\]) positive. j) History of immunodeficiency, including other acquired or congenital immunodeficiency disorders, or history of organ transplantation. k) History of psychiatric disorder, family history of psychiatric disorder, or mood disorder as determined by the investigator or psychologist \\[including medical records of depressive episodes, bipolar disorder (Type I or II), obsessive-compulsive disorder, schizophrenia, history of suicide attempt or suicidal ideation, or homicidal ideation (immediate risk of harm to others), or anxiety grade 3 or above, etc.\\].\n15. Known severe hypersensitivity to BEBT-908 for injection or any component of CHOP regimen or any excipient in their formulations.\n16. Female participants who are pregnant or breastfeeding, or participants who cannot guarantee use of contraceptive measures during the study and for at least 6 months after the last dose of study drug.\n17. Any unstable condition or condition that may jeopardize participant safety or compliance with the study, as determined by the investigator.\n18. Participants deemed by the investigator as unsuitable for treatment under this protocol.","ALL","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical study is to find the best way to combine the study drug BEBT-908 (ifupinostat hydrochloride for injection) with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) for treating previously untreated peripheral T-cell lymphoma, and to find out whether this best combination is better than standard CHOP treatment alone.\n\nThe main questions this study will try to answer are:\n\nWhat percentage of participants will respond well to treatment with BEBT-908 plus CHOP? Is BEBT-908 plus CHOP better than standard CHOP treatment? What medical problems will participants have while receiving this combination treatment?\n\nThis study includes an Exploration Phase and an Expansion Phase. The Exploration Phase has 3 cohorts. All participants receive both BEBT-908 and CHOP, but the dosing arrangements differ across cohorts: the dose of BEBT-908 differs, the sequencing of administration differs, and whether participants continue with CHOP or transition to BEBT-908 depends on their tolerability to CHOP. Eligible participants will receive the combination treatment for their assigned cohort. After that, based on the results from all 3 cohorts in the Exploration Phase, one optimal cohort will be selected to proceed into the Expansion Phase. In the Expansion Phase, eligible participants will be randomly assigned (like flipping a coin) in a 1:1 ratio to either the treatment group, receiving the optimal combination regimen identified in the Exploration Phase, or the control group, receiving 6 cycles of CHOP. This study design will help investigators find the best way to combine BEBT-908 and CHOP for treating previously untreated peripheral T-cell lymphoma, and check whether this optimal combination regimen is better than standard CHOP treatment.",[27],"Previously Untreated Peripheral T-Cell Lymphoma",[29,30,31,32,33],"BEBT-908","PTCL","Safety","Pharmacokinetics","Efficacy","NOT_YET_RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"BeBetter Med Inc","INDUSTRY",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100634774","phase-2-a-study-of-bebt-209-plus-chemotherapy-in-patients-with-locally-advanced-or-metastatic-triple-negative-breast-cancer-100634774","NCT07544056","A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer","A Randomized, Controlled, Open-label, Multi-center, Phase IIb\u002FIII Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Age and gender: Female, aged 18 to 75 years (inclusive).\n2. Informed consent: Voluntarily signed the written informed consent form (ICF).\n3. Diagnosis: Pathologically confirmed hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic triple-negative breast cancer (TNBC).\n4. HR-negative: \\\u003C1% of nuclei stain positive for estrogen receptor (ER) and progesterone receptor (PR) by immunohistochemistry (IHC). HER2-negative: IHC 0, 1+, or IHC 2+ with negative in situ hybridization (ISH).\n5. Prior therapy: Must have received at least one but no more than two prior systemic therapies for unresectable locally advanced or metastatic disease. Progression within 12 months of completion of neoadjuvant\u002Fadjuvant therapy is considered one line of systemic therapy.\n6. Measurable disease: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with stable status within 2 weeks prior to screening (clinically insignificant decline).\n8. Life expectancy: At least 12 weeks.\n9. Organ function: Adequate organ and bone marrow function (no blood transfusion or growth factors within 2 weeks prior to screening):\n\n(1)Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³; (2) Platelets ≥ 100,000\u002Fmm³; (3) Hemoglobin ≥ 9 g\u002FdL; (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (or ≤ 5.0 × ULN with liver metastases); (5) Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN with liver metastases); (6) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault).\n\n10.Toxicity recovery: Prior anti-cancer therapy toxicities resolved to ≤ grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 (excluding alopecia or other stable toxicities deemed safe by the investigator).\n\n11.Contraception: Negative serum pregnancy test within 7 days before treatment for women of childbearing potential. Agree to use highly effective contraception during the study and for 6 months after the last dose.\n\nNote: The initial documentation of locally advanced or metastatic disease must be supported by biopsy, pathology, or imaging reports with specific dates. Systemic therapy includes systemic treatments for TNBC, such as chemotherapy, targeted therapy, and immunotherapy.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Prior treatment history: Prior treatment with gemcitabine.\n2. Prior treatment with carboplatin for unresectable locally recurrent or metastatic breast cancer (unless completed in the (neo)adjuvant setting \\>6 months prior to first metastatic relapse).\n3. Central nervous system (CNS) metastases: Known CNS metastases or leptomeningeal disease (including leptomeningeal metastases, spinal cord metastases, spinal cord compression, and unstable brain metastases). Participants with stable brain metastases (clinically\u002Fradiographically stable for at least 4 weeks) are eligible.\n4. Pulmonary conditions: Clinically significant pulmonary diseases (e.g., pulmonary embolism within 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, significant pleural effusion) or autoimmune\u002Finflammatory diseases with lung involvement. Current interstitial lung disease (ILD)\u002Fpneumonitis requiring systemic steroids, or active ILD\u002Fpneumonitis suggested by baseline imaging.\n5. Effusion and cachexia: Uncontrolled moderate to large pleural, pericardial, or abdominal effusion requiring repeated drainage, or cachexia.\n6. Transplantation: Prior history of hematopoietic stem cell or bone marrow transplantation.\n7. Prohibited concomitant medications (within 7 days prior to first dose):\n\n(1) Strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers; (2) Medications known to significantly prolong the QT interval or cause torsades de pointes (e.g., quinidine, disopyramide, procainamide, sotalol).\n\n8.Washout periods for prior anti-tumor therapy: Radiotherapy or oral small-molecule targeted therapy within 14 days; cytotoxic chemotherapy within 21 days; systemic anti-tumor therapies (e.g., macromolecules, immune checkpoint inhibitors, antibody-drug conjugates (ADCs)) within 28 days; cell therapy within 3 months.\n\n9.Hypersensitivity: Known or suspected hypersensitivity to BEBT-209, carboplatin, gemcitabine, or any of their excipients.\n\n10.Cardiac abnormalities: Significant electrocardiogram (ECG) abnormalities: QTcF \\> 480 msec (based on the mean of triplicate ECGs if the first is \\>480 msec); History of long QT syndrome (personal or family); Clinically significant ventricular arrhythmia or current use of anti-arrhythmic drugs\u002Fimplantable cardioverter-defibrillator (ICD).\n\n11.Electrolyte imbalance: Uncontrolled electrolyte disturbances (e.g., hypocalcemia \\\u003C1.0 mmol\u002FL, hypokalemia \\\u003C3.0 mmol\u002FL, hypomagnesemia \\\u003C0.5 mmol\u002FL) that increase QTc prolongation risk (re-screening allowed after intervention).\n\n12.Cardiovascular\u002Fcerebrovascular disease (within 6 months):\n\n1. New York Heart Association (NYHA) Class III-IV congestive heart failure or uncontrolled heart failure\u002Fcoronary artery disease;\n2. Clinically significant arrhythmias (e.g., symptomatic atrial fibrillation\u002Fflutter) or NCI CTCAE v6.0 grade ≥ 3 arrhythmias;\n3. Myocardial infarction, severe\u002Funstable angina, stroke, transient ischemic attack (TIA), symptomatic pulmonary embolism, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI);\n4. Refractory hypertension: systolic blood pressure (SBP) \\> 160 mmHg and\u002For diastolic blood pressure (DBP) \\> 100 mmHg despite ≥ 3 types of antihypertensive medications.\n\n13.Gastrointestinal issues: Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, gastrectomy, or any malabsorption syndrome that may impair BEBT-209 absorption.\n\n14.Active infections of clinical significance, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases, and active syphilis infection.\n\nActive hepatitis B is defined as positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) with HBV DNA above the upper limit of normal (ULN) of the study center. Patients with HBV DNA quantification above the ULN are permitted to receive antiviral therapy prior to screening and may be enrolled once viral load decreases to within the normal range; however, anti-HBV therapy must be continued throughout the study period.\n\nActive hepatitis C is defined as HCV RNA above the detection limit. Active syphilis infection is defined as positive treponemal antibody with positive nontreponemal test (rapid plasma reagin \\[RPR\\] or toluidine red unheated serum test \\[TRUST\\]).\n\n15.Diabetes: Poorly controlled diabetes (hemoglobin A1c (HbA1c) ≥ 8.5%). 16.Other malignancies: Other progressive malignancies or malignancies treated within the past 5 years (excluding cured basal\u002Fsquamous cell skin cancer or cervical carcinoma in situ).\n\n17.Psychiatric\u002Fneurological conditions: Active suicidal ideation or behavior within 3 months; current neurological disorders ≥ NCI CTCAE v6.0 grade 2.\n\n18.General exclusion: Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, increases participant risk or interferes with study results.","FEMALE",{"count":56,"type":21},446,[24,58],"PHASE3","Title: A Study to See if BEBT-209 Combined With Chemotherapy Works to Treat People With Triple-Negative Breast Cancer Researchers want to learn if a new drug called BEBT-209 works to treat people with a specific type of breast cancer. This cancer is called locally advanced or metastatic triple-negative breast cancer (TNBC).\n\nThe study has two parts. In the first part, researchers want to see if the new drug combination can shrink tumors. In the second part, researchers want to see if this treatment helps people live longer.\n\nResearchers will put participants into two groups by chance. This is like flipping a coin.\n\nGroup 1: Participants get BEBT-209 plus two chemotherapy drugs. These drugs are Carboplatin and Gemcitabine.\n\nGroup 2: Participants get only the two chemotherapy drugs. Researchers will group people based on the treatments they had in the past.\n\nResearchers will also check:\n\nHow long the treatment keeps the cancer from growing. This is called progression-free survival (PFS).\n\nIf the treatment is safe. Researchers will look for adverse events (AE), such as low blood cell counts.\n\nHow participants feel. This is called health-related quality of life (HRQoL). How the body uses the drug.",[61,62],"Locally Advanced Triple-negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[64,65,66,67,68,69],"BEBT-209","Metastatic Triple-Negative Breast Cancer","CDK4\u002F6 Inhibitors","Chemotherapy","Phase IIb\u002FIII Clinical Study","Locally Advanced Triple-Negative Breast Cancer","2026-04-18",{"date":72,"type":38},"2026-04-22",{"date":74,"type":21},"2026-04",{"date":76,"type":21},"2030-12",{"name":44,"class":45},2,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100621283","phase-1-a-study-of-bebt-701-in-patients-with-mild-to-moderate-hypertension-and-elevated-low-density-lipoprotein-cholesterolldl-c-100621283","NCT07368608","A Study of BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol（LDL-C）","A Randomized, Double-blind, Placebo-controlled Phase I\u002FII Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous BEBT-701 in Patients With Mild to Moderate Hypertension and Elevated LDL-C","Inclusion Criteria:\n\n1. Male or female aged 18 to 60 years (inclusive).\n2. Subjects with essential hypertension who are either treatment-naive or have remained off any antihypertensive medication for ≥ 30 days prior to screening and in whom the investigator deems no additional antihypertensive therapy necessary during the study period.\n3. Body-mass index (BMI) 18.6-30kg\u002Fm² (inclusive); body weight ≥ 50 kg for men and ≥ 45 kg for women.\n4. Has maintained a stable diet for at least 4 weeks before screening and has no plan to make a clinically significant change in diet or body weight during the study (a change \\> 10 % is considered significant).\n5. Agrees to use a highly effective method of contraception and to avoid becoming a parent from enrollment until 12 months after the last dose.\n6. Able to understand the study requirements, willing to comply, and provides written informed consent.\n\n   Phase I subjects must simultaneously meet the following criteria:\n7. At screening and within 24 h before randomization, the 24-h ambulatory blood-pressure monitoring shows mean systolic blood pressure (SBP) \\> 130 mmHg and \\\u003C 150 mmHg.\n8. At screening and baseline, fasting serum LDL-C is ≥ 100 mg\u002FdL (2.6 mmol\u002FL) and \\\u003C 190 mg\u002FdL (4.9 mmol\u002FL) in subjects who are either lipid-lowering-therapy-naive or have not received any lipid-lowering drug within 30 days before screening and whom the investigator judges will not require any additional lipid-lowering therapy during the study.\n\n   Phase II subjects must simultaneously meet the following criteria:\n9. At screening and within 24h before randomization, 24-h ambulatory blood-pressure monitoring must show mean SBP \\> 130 mmHg and \\\u003C 160 mmHg.\n10. At screening and baseline, fasting serum LDL-C ≥ 100 mg\u002FdL (2.6 mmol\u002FL). Subjects already on statin therapy must have been on a stable statin dose and regimen for at least 30 days prior to screening and must have no planned changes to their statin treatment during the study.\n\nExclusion Criteria:\n\n1. Any history of severe illness-apart from hypertension and hyperlipidemia-that in the investigator's opinion could influence trial outcomes, including but not limited to diseases of the circulatory system (e.g., orthostatic hypotension, NYHA class II-IV heart failure, aortic stenosis, major aortic aneurysm or dissection, hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, significant arrhythmias), endocrine, neurologic, gastrointestinal, genitourinary, hematologic, immunologic, psychiatric, or metabolic disorders.\n2. History of allergic disease or atopic diathesis (≥3 drug or food allergies), or known hypersensitivity to oligonucleotide-based therapeutics.\n3. Use of anti-PCSK9 or anti-AGT antibody agents within 6 months before screening, or of PCSK9- or AGT-targeted oligonucleotide drugs within 12 months before screening.\n4. Malignancy within 5 years before informed-consent signature (exceptions: adequately resected and cured basal- or squamous-cell skin carcinoma, cervical carcinoma in situ, or other cancers considered cured by surgery alone).\n5. Left-ventricular ejection fraction (LVEF) \\\u003C 40% at screening; or significant aortic or peripheral vascular disease, or any vascular condition requiring surgical intervention.\n6. Type 1 diabetes, or type 2 diabetes with inadequate glycaemic control (HbA1c ≥ 8%).\n7. Major surgery within 6 months before dosing, or planned major surgery during the study period.\n8. Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m² (by simplified MDRD equation) or urine albumin-to-creatinine ratio (UACR) \\> 300 mg\u002Fg at screening.\n9. At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin(TBIL),gamma-glutamyl transferase(GGT), or alkaline phosphatase(ALP) \\> 1.5 × upper limit of normal (ULN), or serum potassium \\> 5.5 mmol\u002FL (one repeat measurement permitted).\n10. Mean 24-h ambulatory diastolic blood pressure (DBP) \\> 110 mmHg at screening and\u002For within 24 h prior to randomization (one repeat measurement permitted).\n11. QT\u002FQTc prolongation at screening or baseline: QT interval corrected by Fridericia's formula (QTcF)≥ 450 ms (men) or ≥ 460 ms (women).\n12. Positive serology for HBsAg, anti-hepatitis C virus(HCV), HCV core antigen, anti-human immunodeficiency virus (HIV), or Treponema pallidum antibody; if Treponema pallidum antibody is positive, a confirmatory rapid plasma reagin(RPR) test is required and must also be positive.\n13. Known or suspected secondary hypertension, including but not limited to bilateral renal-artery stenosis, primary aldosteronism, pheochromocytoma, polycystic kidney disease, or drug-induced hypertension.\n14. Occupations involving hazardous operations such as piloting vessels or working at height.\n15. Subcutaneous-injection intolerance, or prominent abdominal scarring, tattoos, or other conditions that could materially interfere with study-drug administration or the assessment of local tolerability.\n16. Blood loss or donation \\> 400 mL within 3 months before dosing (menstrual bleeding excluded) and\u002For platelet donation within 2 weeks.\n17. Use, within 28 days before dosing, of any drug, nutraceutical, vitamin, or dietary supplement known to affect lipid metabolism.\n18. History of drug abuse or positive urine drug screen, and\u002For use of illicit drugs within 3 months before screening, and\u002For habitual use of any psychoactive substance (including herbal preparations).\n19. Average daily consumption \\> 5 cigarettes (or equivalent e-cigarette use) within 3 months before screening and\u002For unwillingness to abstain from all tobacco products during the study.\n20. Regular alcohol consumption within 6 months before screening (i.e., \\> 14 units\u002Fweek; 1 unit = 360 mL of 5% beer, 45 mL of 40% spirits, or 150 mL of 12% wine) and inability to comply with alcohol-restriction requirements during the study.\n21. Daily intake of excessive tea, coffee, and\u002For caffeine-containing beverages (≥ 8 cups\u002Fday; 1 cup = 250 mL) within 1 month before screening.\n22. Participation in any clinical trial within 3 months before screening (12 months for oligonucleotide investigational drugs).\n23. Subjects who, for any other reason, are unlikely to complete the study or whom the investigator deems should not be enrolled.\n24. Pregnant or lactating women.\n25. History of syncope within 3 months before screening.\n26. Receipt of a live vaccine within 4 weeks before screening or planned live-vaccine administration during the study.\n27. Use of long-acting estrogen and\u002For progestin injections or implants within 6 months before dosing.\n28. Women of child-bearing potential who engaged in unprotected intercourse with a partner within 28 days before dosing.","60 Years",{"count":88,"type":21},340,[90,24],"PHASE1","This Phase I\u002FII clinical trial is designed to evaluate, through a single-dose Phase I segment and a multiple-dose Phase II segment, the safety\u002Ftolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) characteristics of BEBT-701 administered by subcutaneous injection in patients with mild to moderate hypertension and elevated LDL-C , and to explore its preliminary efficacy.",[93],"Mild to Moderate Hypertension and Elevated Low-Density Lipoprotein Cholesterol",[95,31,96,32,97],"BEBT-701","Tolerability","Preliminary Efficacy","2026-01-20",{"date":100,"type":38},"2026-01-26",{"date":100,"type":21},{"date":103,"type":21},"2029-06-30",{"name":44,"class":45},1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":105},"100593874","phase-1-study-of-bebt-507-injection-in-subjects-with-polycythemia-vera-pv-100593874","NCT07012109","Study of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)","A Multicenter, Open-Label Phase I Clinical Trial of BEBT-507 Injection in Subjects With Polycythemia Vera (PV)","Inclusion Criteria:\n\n1. Male and female subjects aged 18-75 years (inclusive);\n2. Subjects diagnosed with polycythemia vera (PV) according to the 2016 world health organization (WHO) criteria;\n3. Hydroxyurea-resistant\u002Fintolerant and\u002For interferon α-resistant\u002Fintolerant:\n\n1)Hydroxyurea-resistant or -intolerant Must meet the definition of hydroxyurea (HU) resistance or intolerance in the 2024 chinese society of clinical oncology (CSCO) Guidelines for the diagnosis and treatment of malignant hematological diseases and satisfy at least one of the following criteria:a) Resistance: Despite ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, phlebotomy is still required to maintain HCT \\\u003C45%; after ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, bone marrow proliferation remains uncontrolled (e.g., platelets \\>400×10⁹\u002FL and WBC \\>10×10⁹\u002FL); after ≥3 months of HU treatment at a dose of ≥2 g\u002Fd, a palpable massive splenomegaly fails to reduce by \\>50% or splenomegaly-related clinical symptoms do not fully resolve;b) Intolerance: At the minimum hydroxyurea (HU) dose required to achieve a complete or partial clinical hematologic response for the disease, absolute neutrophil count (ANC) \\\u003C1.0×10⁹\u002FL or PLT count \\\u003C100×10⁹\u002FL or Hemoglobin (HGB) \\\u003C100 g\u002FL occurs; during HU treatment at any dose, lower extremity ulcers or other intolerable non-hematological toxicities emerge, such as skin and mucous membrane manifestations (skin, teeth, or nail darkening; oral ulcers, mucositis; skin ulcers, rash, etc.), gastrointestinal symptoms (nausea, anorexia, indigestion, vomiting, abdominal pain, constipation, etc.), pneumonia, fever, etc.; 2)Interferon α-resistant or -intolerant Must satisfy at least one of the following criteria:a) Resistance: After achieving at least 12 weeks of interferon α therapy and a dose of at least 25×10⁶ U\u002Fweek (or the subject's maximum tolerated dose if it is less than 25×10⁶ U\u002Fweek), phlebotomy is still required to maintain HCT \\\u003C45%, or PLT \\>400×10⁹\u002FL and WBC \\>10×10⁹\u002FL, or palpable splenomegaly (starting \\>10 cm from the left costal margin) fails to reduce by \\>50%;b) Intolerance: At the minimum interferon α dose required for complete or partial clinical hematologic remission, ANC \\\u003C1.0×10⁹ or PLT \\\u003C100×10⁹ or hemoglobin \\\u003C100 g\u002FL (\\\u003C10 g\u002FdL) occurs, or depression, influenza-like symptoms, neuropsychiatric symptoms, autoimmune issues, or other unacceptable non-hematological toxicities related to interferon-alpha (IFN-α) emerge, defined as common terminology criteria for adverse events (CTCAE) V5.0 grade 3-4 events, or CTCAE V5.0 grade 2 events lasting over 1 week, or permanent discontinuation of interferon α, or interruption of interferon α until toxicity resolves, or hospitalization due to interferon α toxicity.\n\n4.The subject has intact skin at the injection site, and the investigator deems it is suitable for subcutaneous injection; 5.Eastern cooperative oncology group (ECOG) performance status score is 0, 1, or 2; 6.The subject has undergone bone marrow biopsy within 12 months prior to enrollment; 7.The subject or the subject's legal guardian has signed a written informed consent, and the subject is able to comply with the study requirements.\n\nExclusion Criteria:\n\n1. A history of intolerance to oligonucleotides, N-Acetylgalactosamine (GalNAc), or excipient components, or a history of intolerance to subcutaneous injections.\n2. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 12 weeks before screening.\n3. Major bleeding event or blood transfusion for bleeding within 6 months before screening.\n4. Meets the international working group for myeloproliferative neoplasms research and treatment criteria for post-PV myelofibrosis.\n5. Received any investigational drug within 6 weeks before the first study drug administration, or not recovered from the effects of prior investigational drugs.\n6. Received any clinical studies or marketed products of GalNAc-targeted drugs within 48 weeks before the first study drug administration.\n7. Laboratory abnormalities:a) Liver function tests: alanine aminotransferase (ALT) or aspartate aminotransferase (AST)\\>2.0×Upper Limit of Normal (ULN), total bilirubin（TBIL）\\>1.5×ULN;b) Renal function tests: estimated glomerular filtration rate (eGFR)\\\u003C60 mL\u002Fmin\u002F1.73㎡ (Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation);c) Blood routine tests: platelet count\\>1000×10⁹\u002FL, WBC count\\>25×10⁹\u002FL;d) Coagulation tests: international normalized ratio (INR)\\>1.5×ULN;e) Others: presence of peripheral blood blasts.\n8. Subjects with symptomatic splenomegaly (e.g., splenic infarction, left upper quadrant fullness or pain, early satiety, portal hypertension).\n9. Due to potential genotoxicity, mutagenicity, and teratogenicity of the study drug, exclude:a) Men and women planning to conceive within 5 years without prior in vitro sperm\u002Fovum preservation;b) Pregnant or breastfeeding women;c) Women within 2 years of menopause unwilling to use acceptable contraception until 6 months after the last study drug dose.\n10. Presence of other active malignancies requiring treatment that may interfere with the study.\n11. Comorbid conditions:a) Poorly controlled diabetes (random glucose≥11.1mmol\u002FL or HbA1c≥8.5% despite antidiabetic treatment) assessed by the investigator;b) Severe pulmonary disease (CTCAE V5.0 grade III-IV);c) Severe cardiac disease (defined as any of the following:Left ventricular ejection fraction (LVEF) \\\u003C50% as determined by multigated acquisition scan (MUGA) or Echocardiogram (ECHO);QT interval corrected using the Fridericia method (QTcF) interval \\>450 ms for males or \\>470 ms for females;Unstable angina;Symptomatic pericarditis;Myocardial infarction within the past 6 months with persistent elevation of cardiac enzymes or evidence of persistent regional wall abnormalities on LVEF assessment;History of congestive heart failure (new york heart association functional class III-IV) or cardiomyopathy;d) Significant renal or hepatic impairment;e) Poorly controlled active hepatitis B or C, or other diseases with clinically significant active infections, including hepatitis B (HBV), hepatitis C (HCV), or syphilis. Active HBV is defined as Hepatitis B Surface Antigen (HBsAg) or Hepatitis B e Antigen (HBeAg) positivity with HBV DNA≥2000 IU\u002Fml (10⁴ copies\u002Fml). If HBV DNA is below this level, antiviral therapy is required until one year post - study. Active HCV is defined as HCV RNA above the assay's upper limit. For syphilis, a positive non-treponemal test requires confirmation with a treponemal antibody test. If the latter is negative and the investigator confirms past infection with syphilitic cure, the subject can be included;f) Known human immunodeficiency virus （HIV） positivity or primary immunodeficiency;g) Deemed unsuitable for study participation due to a history of psychosis, family history of psychiatric illness, or mood disorders, as determined by the investigator or psychiatrist;h) Uncontrolled hypertension (systolic BP≥180mmHg and\u002For diastolic BP≥110mmHg);i) Severe medical conditions with a risk of major bleeding or history of major bleeding.\n12. Concomitant use of drugs that may prolong the QT interval or cause torsades de pointes.\n13. History of alcohol or drug abuse within the past year.\n14. Subjects deemed unsuitable for this treatment regimen by the investigator.",{"count":114,"type":21},90,[90],"This is a multicenter, open-label Phase I clinical trial of BEBT-507 in subjects with polycythemia vera(PV). Phase Ia is a single-agent dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of BEBT-507 in subjects with PV . Based on the results of Phase Ia, two doses will be selected for further evaluation in Phase Ib to assess the efficacy, safety, and PK profile of BEBT-507 in subjects with PV , and to recommend a dose for Phase III clinical trials.",[118],"Polycythemia Vera",[120,31,32,33],"BEBT-507","2025-05-30",{"date":123,"type":38},"2025-06-10",{"date":125,"type":21},"2025-06-05",{"date":127,"type":21},"2028-07-31",{"name":44,"class":45},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":139,"conditions":140,"keywords":142,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":150,"locationsCount":105},"100592797","phase-3-study-of-bebt-209-in-combination-with-fulvestrant-versus-placebo-in-combination-with-fulvestrant-in-patients-with-hrher2--locally-advanced-or-metastatic-breast-cancer-who-have-progressed-after-prior-endocrine-therapy-100592797","NCT06998108","Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+\u002FHER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy","A Multicenter, Randomized, Controlled, Double-blind Phase III Clinical Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant for the Treatment of HR+\u002FHER2- Locally Advanced or Metastatic Breast Cancer in Patients With Disease Progression After Prior Endocrine Therapy","Inclusion Criteria:\n\n1. Women aged 18 years or older who are postmenopausal or premenopausal\u002Fperimenopausal, and meet one of the following criteria: previous bilateral oophorectomy, or age ≥60 years; or age \\\u003C60 years with natural menopause (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), and estradiol (E2) and follicle-stimulating hormone (FSH) levels in the postmenopausal range; or premenopausal or perimenopausal women willing to receive luteinizing hormone-releasing hormone (LHRH) agonist therapy during the study period.\n2. Patients with histologically confirmed HR+\u002FHER2- breast cancer (based on the most recent test results from either recurrent\u002Fmetastatic lesion tissue samples or prior primary lesion tissue samples): a) ER+ and\u002For PR+ is defined as ≥10% of tumor cells showing positive staining for ER\u002FPR; b) HER2- is defined as an immunohistochemistry(IHC) score of 0 or 1+, or a fluorescence in situ hybridization(FISH) ratio of HER2\u002FCEP17 less than 2.0, or HER2 gene copy number less than 4.\n3. Evidence of focal recurrence or metastasis, not suitable for curative surgery or radiotherapy, and without clinical indications necessitating chemotherapy.\n4. Previous endocrine therapy must meet one of the following criteria: a) progression during or within 12 months after discontinuation of adjuvant endocrine therapy (with an aromatase inhibitor \\[aromatase inhibitor or selective estrogen receptor modulator such as tamoxifen, toremifene, etc.); b) progression during or within 1 month after discontinuation of endocrine therapy for first recurrence or metastasis.\n5. Patients are allowed to have received no more than one line of chemotherapy during the recurrence or metastatic phase.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.\n7. Presence of measurable lesions according to response evaluation criteria in solid tumors (RECIST) 1.1 criteria or bone metastases only (including lytic or mixed lesions).\n8. Adequate organ and marrow function, defined as follows: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL (without use of growth factors within 14 days); platelets ≥100×10⁹\u002FL (without corrective treatment within 7 days); hemoglobin ≥90 g\u002FL (without corrective treatment within 7 days); serum creatinine ≤1.5 times the upper limit of normal (ULN) or estimated creatinine clearance ≥60 mL\u002Fmin; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the ULN (≤5 times the ULN for patients with liver metastases); total serum bilirubin (TBIL) ≤2.5 times the ULN; 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 msec (for females).\n9. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug and must be willing to use a medically accepted and highly effective method of contraception from the time of signing the informed consent form, throughout the study period, and for 1 year after the last administration of the study drug.\n10. All acute toxicities from prior anti-tumor therapy must have resolved to grade 0-1 (according to national cancer institute(NCI) common terminology criteria for adverse events(CTCAE) version 5.0) or to the levels specified in the inclusion\u002Fexclusion criteria. Exceptions include alopecia and other toxicities deemed by the investigator to pose no safety risk to the patient.\n11. The patient has provided written informed consent and is willing and able to comply with the planned visits, study treatment schedule, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Patients who are deemed by the investigator to be unsuitable for endocrine therapy, including those with symptomatic, visceral metastatic disease, or those at risk of life-threatening complications in the short term (including patients with uncontrollable effusions \\[pleural, pericardial, peritoneal\\] despite drainage or other measures, pulmonary lymphangitis, or more than 50% liver involvement).\n2. Known uncontrolled or symptomatic active central nervous system (CNS) metastases, characterized by clinical symptoms, brain edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and\u002For progressive growth; patients with a history of CNS metastases or spinal cord compression may be eligible if they have received definitive treatment and have been clinically stable for 4 weeks after discontinuation of anticonvulsants and corticosteroids prior to the first dose of study drug.\n3. Previous treatment with fulvestrant, everolimus, or CDK4\u002F6 inhibitors.\n4. From the end of the last treatment to the first dose: underwent surgical or radiation therapy within 14 days prior to the first dose and has not fully recovered from the treatment; received chemotherapy, any investigational drug, or other anti-cancer therapy within 14 days or within five half-lives of the therapeutic agent prior to the first dose (whichever is longer is acceptable for enrollment).\n5. A diagnosis of any other malignancy within 3 years prior to randomization, with the exception of non-melanoma skin cancer (basal cell or squamous cell carcinoma) or cervical carcinoma in situ that has been treated with curative intent.\n6. Infection with human immunodeficiency virus (HIV) or known acquired immune deficiency syndrome (AIDS); active hepatitis B (patients positive for hepatitis B surface antigen \\[HBsAg\\] and with hepatitis B virus DNA \\[HBV-DNA\\] levels above the ULN of the local laboratory). Patients with HBV DNA levels above the ULN of the local laboratory are permitted to receive antiviral therapy prior to screening, and may be enrolled once viral copies are reduced below the ULN, but must continue antiviral therapy for hepatitis B during the study; hepatitis C (positive for hepatitis C virus antibody and with HCV RNA levels above the ULN of the local laboratory); or co-infection with both hepatitis B and hepatitis C.\n7. Within 6 months prior to randomization, the following conditions have occurred: myocardial infarction, severe\u002Funstable angina, heart failure of NYHA Class II or higher, persistent arrhythmia of Grade ≥2 (according to NCI CTCAE Version 5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or symptomatic pulmonary embolism.\n8. Severe infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungal, or antiviral therapy according to clinical practice guidelines), or unexplained fever \\>38.5℃ during the screening period or prior to the first dose.\n9. Inability to swallow, intestinal obstruction, or other factors that may affect the intake and absorption of medication.\n10. Known coagulation abnormalities; or use of anticoagulant therapy prior to intramuscular injection of fulvestrant or LHRH agonist (goserelin).\n11. Known allergy to fulvestrant, LHRH agonist (goserelin), BEBT-209\u002Fplacebo, or any of their excipients.\n12. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n13. Known history of abuse of psychoactive substances or drug addiction.\n14. Poorly controlled diabetes mellitus as judged by the investigator.\n15. Uncontrolled hypertension as judged by the investigator.\n16. Presence of other severe physical or psychiatric conditions or laboratory abnormalities that may increase the risk of participation in the study, interfere with the study results, or render the patient unsuitable for participation in the study as judged by the investigator.",{"count":137,"type":21},330,[58],"This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+\u002FHER2- locally advanced or metastatic breast cancer.",[141],"HR+\u002FHER2- Locally Advanced, Metastatic Breast Cancer",[64,33,31],"RECRUITING","2025-05-29",{"date":146,"type":38},"2025-05-31",{"date":148,"type":38},"2022-06-09",{"date":37,"type":21},{"name":44,"class":45},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":171,"locationsCount":105},"100576973","phase-3-study-comparing-bebt-908-combined-with-r-to-soc-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100576973","NCT06792253","Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. The subject has been fully informed and is willing to sign the Informed Consent Form (ICF).\n2. Age is ≥18 years and ≤75 years, both men and women are eligible.\n3. Pathologically diagnosed as diffuse large B-cell lymphoma according to the 2022 World Health Organization classification, confirmed by central pathology review (Patients who relapse after more than one year need to undergo tissue biopsy again to confirm the pathological diagnosis.).\n4. Measurable lesions \\[The criteria for measurable lesions are: the longest diameter of lymph node lesions measured by enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is greater than 15 mm, and the longest diameter of extranodal lesions is greater than 10 mm.\\] assessed by Positron Emission Tomography\u002FComputed Tomography (PET-CT) and Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to the Lugano 2014 criteria .\n5. Must have relapsed or refractory diffuse large B-cell lymphoma after at least one systemic therapy \\[Salvage chemotherapy and immunotherapy after stem cell transplantation will be considered as first-line systemic treatment; maintenance therapy will not be counted as a separate line of systemic treatment; local radiotherapy for diffuse large B-cell lymphoma (DLBCL) aimed at cure will not be counted as first-line systemic treatment; patients who do not achieve PR after four cycles of first-line treatment are eligible for the study; patients who do not achieve PR after two cycles of second-line or higher treatment are eligible for the study. Primary refractory DLBCL patients are defined as those who have no response during first-line treatment or relapse within six months after the end of treatment, and they will be allowed to participate in the study. Patients who relapse within 12 months after stem cell transplantation are also eligible for inclusion. Refractory DLBCL patients are those who do not achieve response after adequate front-line treatment (at least four cycles of first-line chemotherapy, or at least two cycles of subsequent treatment), or who progress during previous first-line treatment, or who progress within six months (less than six months) after achieving response to previous adequate front-line treatment, or who relapse within 12 months after achieving response to stem cell transplantation. Relapsed DLBCL patients are those who relapse six months or more after achieving response to previous adequate front-line treatment, or who relapse 12 months or more after achieving response to stem cell transplantation.\\], and at least one systemic therapy must include CD20 antibody.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n7. Expected survival \\>12 weeks.\n8. Organ function levels must meet the following requirements:\n\nPeripheral blood:\n\n1. Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL;\n2. Hemoglobin (HGB) ≥80g\u002FL;\n3. Platelet count (PLT) ≥100×10\\^9\u002FL;\n\nLiver and kidney function:\n\n1. Serum total bilirubin ≤1.5×Upper Limit of Normal (ULN) (for patients with Gilbert syndrome, total bilirubin \\\u003C3.0×ULN with direct bilirubin within normal range);\n2. Serum creatinine \\\u003C1.5×ULN;\n3. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if there is liver involvement).\n\nExclusion Criteria:\n\n1. Known severe allergy to the study drug or any of its excipients;\n2. Due to the potential genotoxicity, mutagenicity, and teratogenicity of the study drug, the following subjects should be excluded:\n\n   1. Men and women who have not undergone in vitro preservation of sperm or oocytes and plan to have children within 5 years, unless subsequent studies confirm reproductive safety;\n   2. Pregnant or breastfeeding women;\n3. Primary central nervous system lymphoma;\n4. DLBCL with active central nervous system brain metastases or meningeal involvement at the time of screening;\n5. Other active malignant tumors that require treatment and may interfere with the study.\n6. Treatment history before the trial:\n\n   1. Received other small molecule targeted drug therapy within 2 weeks before enrollment;\n   2. Previously received BEBT-908 or R-ICE and R-GemOx therapy before enrollment;\n   3. Underwent autologous hematopoietic stem cell transplantation within 3 months before enrollment;\n   4. Received radiotherapy that affects the evaluation of the efficacy of this study within 3 months before enrollment, or local supportive radiotherapy that affects the subject's bone marrow function;\n   5. Underwent myelosuppressive chemotherapy or biological therapy within 3 weeks before enrollment;\n   6. Used traditional Chinese medicine and patent medicine with antitumor effects within 2 weeks before enrollment;\n   7. Underwent major surgery (Referring to the Level 3 and Level 4 surgeries as stipulated in the \"Administrative Measures for the Clinical Application of Medical Technologies\" implemented on May 1, 2009.) other than tumor biopsy within 4 weeks before enrollment, or the side effects of the surgery have not yet stabilized;\n   8. Received any hematopoietic cell colony-stimulating factor therapy (such as granulocyte colony-stimulating factor G-CSF, granulocyte-macrophage colony-stimulating factor GM-CSF) or thrombopoietin TPO therapy (Subjects who have started receiving erythropoiesis-stimulating agents or darbepoetin within 2 weeks prior to enrollment are eligible for inclusion.) within 2 weeks before enrollment;\n   9. Received prednisone \\>10mg per day (or other equivalent doses of glucocorticoids) within 7 days before enrollment \\[If used for the treatment of diseases other than lymphoma, such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma, subjects may receive a stable dose of up to 10 mg per day of prednisone (or an equivalent dose of other glucocorticoids).\\];\n   10. Underwent chimeric antigen receptor T cell immunotherapy (CAR-T therapy) within 3 months before enrollment.\n7. After the previous treatment (chemotherapy or biological therapy), there are persistent Grade 2 or higher \\[Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria\\] toxicities that have not stabilized at the time of enrollment (alopecia excluded);\n8. There is an active clinical severe infection of Grade 2 or higher (CTCAE V5.0 criteria);\n9. Co-morbid conditions:\n\n   1. Poorly controlled diabetes mellitus \\[with a random blood glucose level ≥11.1 mmol\u002FL or Glycosylated Hemoglobin, Type A1C (HbA1c) ≥8.5% despite hypoglycemic treatment\\];\n   2. Severe pulmonary disease (CTCAE V5.0 Grade III-IV);\n   3. Severe cardiac disease \\[Including any of the following: left ventricular ejection fraction (LVEF) \\\u003C50% detected by cardiac radionuclide scan \\[Multigated Acquisition (MUGA)\\] or echocardiogram (ECHO); Fridericia-corrected QT value (QTcF interval) \\>450ms for males and \\> 470ms for females (QTcF formula); unstable angina; symptomatic pericarditis; myocardial infarction within the past 6 months with persistent elevation of cardiac enzymes or persistent regional left ventricular wall abnormalities recorded during LVEF measurement; history of congestive heart failure (New York Heart Association Class III-IV), or history of cardiomyopathy.\\].\n   4. Significant renal or hepatic dysfunction;\n   5. Uncontrolled active hepatitis B, hepatitis C, syphilis (individuals with both specific and non-specific syphilis antibodies positive), and active Epstein-Barr virus infection \\[The following active infections with clinical significance, including hepatitis B (HBV), hepatitis C (HCV), and syphilis. Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) or hepatitis B core antibody positive, and HBV DNA ≥ 2000 IU\u002Fml (approximately equal to 10\\^4 copies\u002Fml), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive, HBV DNA \\\u003C 2000 IU\u002Fml, according to the requirements of infectious disease control, the subject should continue to take antiviral drug treatment); active hepatitis C is defined as: HCV RNA above the upper limit of detection; positive syphilis spirochete antibody test, should be tested for non-specific syphilis spirochete antibodies \\[Rapid Plasma Reagin Test (PRP) or Toluidine Red Unheated Serum Test (TRUST)\\], the latter is negative and the subject is judged by the researcher to have been infected with syphilis in the past but has been cured can be included; current EB virus infection refers to EB virus serological detection of Epstein-Barr Virus Capsid Antigen Immunoglobulin M (VCA-IgM), Epstein-Barr Virus Early Antigen Immunoglobulin G (EA-IgG) positive or EB virus DNA test positive.\\];\n   6. Known positive for human immunodeficiency virus (HIV);\n   7. History of mental illness, family history of mental illness, or mood disorders as judged by the investigator or psychiatrist \\[Including a medical history of depressive episodes, bipolar disorder (Type I or II), obsessive-compulsive disorder, schizophrenia, suicide attempts or suicidal ideation, or thoughts of killing (immediate risk of harming others), and anxiety levels above Grade 3.\\], and deemed unsuitable for enrollment by the investigator;\n   8. Need for concomitant anticoagulant or antiplatelet therapy during the study period;\n   9. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg);\n   10. Severe internal medical conditions with a risk of major bleeding or a history of major bleeding.\n10. Concurrent use of drugs that may cause QT interval prolongation or torsades de pointes;\n11. Within 4 weeks prior to enrollment, currently receiving or requiring treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 isoenzyme after enrollment (Within 4 weeks prior to enrollment and during the study period, subjects must not receive treatment with strong inhibitors or inducers of the cytochrome P450 (CYP) 3A4 isoenzyme. However, concurrent treatment with moderate or weak CYP3A4 inhibitors is permitted.);\n12. Within 4 weeks prior to enrollment, participated in other clinical trials and used investigational drugs;\n13. Any unstable condition or situation that may jeopardize the subject's safety and compliance with the study as judged by the investigator;\n14. Subjects deemed unsuitable for treatment with this protocol by the investigator.",{"count":159,"type":21},416,[58],"This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \\[Standard of Care (SOC)\\] \\[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\\] for the treatment of relapsed\u002Frefractory diffuse large B-cell lymphoma (r\u002Fr DLBCL).",[163],"Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma",[29,33,31],"2025-01-20",{"date":167,"type":38},"2025-01-24",{"date":169,"type":38},"2025-01-06",{"date":103,"type":21},{"name":44,"class":45},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":22,"phases":181,"briefSummary":182,"conditions":183,"keywords":186,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":78},"100570397","phase-2-study-of-bebt-109-in-subjects-with-egfr-exon-20-insertion-mutations-non-small-cell-lung-cancer-100570397","NCT06706713","Study of BEBT-109 in Subjects With EGFR Exon 20 Insertion Mutations Non-Small Cell Lung Cancer","An Apen-label, Multicenter Phase II Study to Evaluate the Efficacy and Safety of BEBT-109 in Patients With EGFR Exon 20 Insertion Mutations in Locally Advanced or Metastatic Non-Small Cell Lung Cancer","Inclusion Criteria:\n\n1. Subjects who have been fully informed and are willing to sign the informed consent form.\n2. Age of at least 18 years, with no gender restrictions.\n3. According to the 8th edition of the American Joint Committee on Cancer (AJCC) lung cancer Tumor Node Metastasis (TNM) staging criteria: histologically or cytologically confirmed locally advanced (stages IIIB or IIIC, and deemed unsuitable for surgery or radiotherapy by the investigator) or metastatic (stage IV) NSCLC.\n4. Written test reports confirm the occurrence of EGFR exon 20 insertion mutations.\n5. Cohort 1 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen) and have not received third-generation EGFR TKI treatment; Cohort 2 includes NSCLC patients who have failed or are intolerant to at least one systemic chemotherapy (defined as having undergone at least one platinum-based chemotherapy regimen or other chemotherapy regimen) and have experienced Progressive Disease after receiving standard doses of third-generation EGFR TKI (such as osimertinib 80 mg once daily, or savolitinib 80 mg once daily, or alectinib 110 mg once daily, etc.).\n6. Eastern Cooperative Oncology Group (ECOG) score of 0-2, with no decline in physical performance in the past two weeks, and an expected survival of at least 12 weeks.\n7. Subjects must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.\n8. Laboratory tests indicate that subjects have adequate organ function: including: a. Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; platelet count (PLT) ≥100×10\\^9\u002FL; hemoglobin (HGB) ≥80g\u002FL; b. Serum total bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤2.5 times ULN (for those with liver metastasis, total bilirubin ≤3 times ULN, AST and ALT ≤5 times ULN are allowed); c. Creatinine ≤1.5 times ULN, when creatinine \\>1.5 times ULN, creatinine clearance must be confirmed, and creatinine clearance must be ≥45 ml\u002Fmin (actual value, or calculated by the Cockcroft-Gault formula); d. Activated partial thromboplastin time (APTT) ≤1.5 times ULN, prothrombin time (PT) ≤1.5 times ULN, international normalized ratio (INR) ≤1.5 times ULN.\n9. If the subject is a female with childbearing potential, she must use adequate contraceptive measures (such as condoms), must not breastfeed, and must have a negative blood pregnancy test before dosing.\n10. male subjects must be willing to use barrier contraceptive measures during the study period, i.e., condoms.\n\nExclusion Criteria:\n\n1. Individuals who have had other malignant tumors within 5 years prior to enrollment, except for basal cell carcinoma of the skin that has been removed and cured, in situ bladder cancer, or in situ cervical cancer.\n2. Those who have previously received drugs for EGFR exon 20 insertion mutations, such as Poziotinib, Tarloxotinib, TAK788, JNJ-61186372, CLN-081, or high-dose third-generation EGFR TKIs (Osimertinib \\> 80 mg\u002Fday, Furmonertinib \\> 80 mg\u002Fday, or Almonertinib \\> 110 mg\u002Fday, etc.).\n3. Any other anti-cancer treatment within 4 weeks prior to the first use of the study drug (including cytotoxic chemotherapy, radiotherapy, immunotherapy, or other biological therapies; for Mitomycin or Nitrosoureas, within 6 weeks; for small molecule targeted drugs, at least 2 weeks or at least 5 half-lives from the last dose, whichever is longer).\n4. Received medication from another clinical trial within 4 weeks prior to the first administration of the study treatment.\n5. Undergone major surgery (excluding vascular access procedures) within 4 weeks prior to the first administration of the study treatment.\n6. Currently using or having used within 1 week known strong inhibitors or inducers of CYP3A4 and CYP2C8, including medications or herbal supplements.\n7. At the start of the study treatment, unresolved toxicities from previous treatments that are more than Grade 1 according to the Common Terminology Criteria for Adverse Events (CTCAE), except for alopecia, and neurotoxicity related to previous platinum treatment can be relaxed to Grade 2.\n8. Spinal cord compression, meningeal metastasis, or brain metastasis, except for those who are asymptomatic, stable, and have not required steroid medication within 4 weeks prior to the start of the study treatment.\n9. Patients with symptomatic and unstable pleural effusion or ascites.\n10. Those with severe or uncontrolled systemic diseases requiring treatment, deemed unsuitable for the trial by the investigator, including hypertension, diabetes, chronic heart failure (New York Heart Association (NYHA) class III-IV), unstable angina, myocardial infarction within 1 year, active bleeding, etc..\n11. Individuals with uncontrolled active infections.\n12. Clinically significant active infections, including Hepatitis B (HBV) and Hepatitis C (HCV). Active Hepatitis B is defined as Hepatitis B surface antigen (HBsAg) positive with detectable HBV DNA copies above the upper limit of normal of the testing laboratory. Patients with HBV DNA copies above the normal limit are allowed to receive antiviral treatment before screening to reduce the viral load to below the normal limit, but must continue antiviral treatment for Hepatitis B during the trial; Active Hepatitis C is defined as HCV RNA above the detection limit.\n13. History of immunodeficiency, including positive Human Immunodeficiency Virus (HIV) antibody tests, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation.\n14. At rest, the average corrected QT interval (QTc) from three Electrocardiogram (ECG) examinations is \\>450 msec (only if the first ECG suggests QTc \\>450 msec, two more measurements are required, and the average of the three values is taken).\n15. Various severe and clinically significant cardiac rhythm, conduction, and resting ECG morphological abnormalities, such as complete left bundle branch block, third-degree block, second-degree block, PR interval \\>250 msec, etc..\n16. Various factors that may increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia (low potassium levels indicated in the screening period blood chemistry, except for those who have been treated with potassium supplements and rechecked as normal before the first dose), congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death before the age of 40.\n17. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease.\n18. Uncontrollable nausea and vomiting, chronic gastrointestinal disease, inability to swallow drug formulations, or previous extensive bowel resection, which may affect the adequate absorption of BEBT-109.\n19. History of hypersensitivity reaction to excipients in the BEBT-109 formulation.\n20. Female subjects who are breastfeeding.\n21. The investigator determines that the subject has any clinical or laboratory examination abnormalities or other reasons that make them unsuitable for the study.",{"count":180,"type":21},200,[24],"This study is an open-label, multicenter Phase II trial, planning to enroll 200 subjects, using BEBT-109 capsules as monotherapy, aimed at evaluating the efficacy and safety of BEBT-109 capsules in subjects with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations in locally advanced or metastatic Non-Small Cell Lung Cancer （NSCLC）.",[184,185],"Non-Small Cell Lung Cancer","EGFR Exon 20 Insertion Mutation",[187,188,33,31],"BEBT-109","EGFR Exon 20 Insertion Mutations","2024-11-25",{"date":191,"type":38},"2024-11-26",{"date":193,"type":38},"2022-04-15",{"date":37,"type":21},{"name":44,"class":45},{"id":197,"slug":198,"hasResults":11,"nctId":199,"briefTitle":200,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":54,"minAge":17,"maxAge":4,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":208,"overallStatus":143,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":78},"100568789","phase-2-a-study-of-bebt-209-in-combination-with-chemotherapy-for-the-treatment-of-advanced-triple-negative-breast-cancer-100568789","NCT06685796","A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer","A Phase II Study of BEBT-209 in Combination With Carboplatin and Gemcitabine for the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Age: ≥18 years old, female;\n2. The subject has fully understood and is willing to sign the Informed Consent Form (ICF);\n3. Confirmed diagnosis of HR-negative, HER2-negative locally recurrent or metastatic breast cancer by pathological biopsy;\n4. Estrogen and progesterone receptor immunohistochemical assessment of tumor tissue is negative (defined as \\\u003C1% nuclear staining), and HER2 is negative (i.e., no overexpression, including local immunohistochemical assessment \\[0 or 1+\\], or immunohistochemical assessment \\[2+\\] with negative in situ hybridization testing);\n5. The subject has previously received 1-2 lines of systemic treatment (if progression within 12 months after the last treatment of adjuvant\u002Fnew adjuvant, it can be considered as one line of treatment);\n6. At least one measurable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;\n7. Eastern Cooperative Oncology Group (ECOG) score of 0-1 , and no decline in physical performance in the past two weeks;\n8. Life expectancy of at least 12 weeks;\n9. Adequate organ and bone marrow function, defined as follows:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³ (1.5 × 10\\^9\u002FL);\n   2. Platelets ≥ 100,000\u002Fmm³ (100 × 10\\^9\u002FL);\n   3. Hemoglobin ≥ 9 g\u002FdL (90 g\u002FL);\n   4. Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) both ≤ 2.5 × ULN, when liver metastasis is present, ALT or AST both ≤ 5.0 × Upper limit of normal value (ULN);\n   5. Total bilirubin (TBIL) ≤ 1.5 × ULN, when liver metastasis is present, ≤ 3.0 × ULN;\n   6. Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 60 mL\u002Fmin (based on the Cockcroft and Gault formula);\n10. All acute toxic reactions from previous anticancer treatments or surgical procedures have resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 ≤ Grade 1 (except for alopecia or other toxicities that the investigator deems have no safety risk to the patient);\n11. Women of childbearing age must have a negative serum pregnancy test within 7 days prior to the start of study medication, and must be willing to use a medically recognized, highly effective contraceptive method (such as intrauterine device, birth control pills, or condoms) during the study period and for one month after the last administration of the study medication.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine;\n2. Previous treatment with carboplatin for locally recurrent unresectable or metastatic breast cancer is allowed if it was administered in the adjuvant or neoadjuvant setting more than 6 months before the first metastatic relapse;\n3. Concurrent central nervous system metastases or leptomeningeal disease requiring immediate radiotherapy or corticosteroid treatment; patients must discontinue steroid medication for at least 14 days before the first administration of the study drug. No stereotactic radiosurgery within 7 days or whole brain radiotherapy within 14 days before the first administration of the study drug;\n4. Previous receipt of hematopoietic stem cell or bone marrow transplantation;\n5. Within 7 days prior to study entry, the patient has received the following treatments:\n\n   1. Medications known to be strong inhibitors\u002Finducers of CYP3A4;\n   2. Medications known to significantly prolong the QT interval or cause torsades de pointes (antiarrhythmic drugs such as quinidine, disopyramide, procainamide, sotalol, etc.);\n6. Within 14 days prior to study entry, the patient has received radiotherapy, or within 21 days prior to study entry, the patient has received other investigational drug treatment or cytotoxic chemotherapy;\n7. Known history of hypersensitivity or suspected allergic symptoms to any component of BEBT-209, carboplatin, or gemcitabine;\n8. In a resting state, the average corrected QT interval (QTc) obtained from 3 Electrocardiogram (ECG) examinations is \\>480msec (corrected using the Fridericia method); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmias, or current use of antiarrhythmic drugs or implantation of defibrillation devices for the treatment of ventricular arrhythmias;\n9. Uncontrolled electrolyte disturbances that may affect the action of QTc-prolonging drugs (such as hypocalcemia \\\u003C1.0mmol\u002FL, hypokalemia \\\u003C lower limit of normal, hypomagnesemia \\\u003C0.5mmol\u002FL), but re-screening is allowed after interventional treatment;\n10. History of myocardial infarction, severe\u002Funstable angina, persistent arrhythmias ≥ Grade 2 according to NCI CTCAE version 5.0, any grade of atrial fibrillation, coronary\u002F peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);\n11. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastrectomy; known malabsorption syndrome or other conditions that may impair the absorption of BEBT-209;\n12. Clinically significant active infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. Active hepatitis B is defined as positive for hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg), and HBV-DNA greater than the upper limit of normal for the research center. Patients with quantitative HBV DNA greater than the upper limit of normal for the research center are allowed to receive antiviral treatment before screening to reduce the viral load to within the normal range, but must continue to receive antiviral treatment for hepatitis B during the trial; active hepatitis C is defined as HCV RNA above the detection limit;\n13. Diabetes with poor blood sugar control as judged by the investigator;\n14. Women who plan to conceive again within 5 years without having undergone oocyte cryopreservation;\n15. Recent or active suicidal ideation or behavior;\n16. Currently participating in or about to participate in other interventional clinical trials;\n17. Other serious acute or chronic medical or psychiatric conditions or laboratory test abnormalities that may increase the risk of participating in the study or the risk associated with the administration of the study drug, or interfere with the study results, and any other conditions that the investigator deems the patient is not suitable to participate in this study.",{"count":20,"type":21},[24],"This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).",[207],"Advanced Triple-Negative Breast Cancer",[64,31,33,209],"In Combination With Chemotherapy","2024-11-11",{"date":212,"type":38},"2024-11-13",{"date":214,"type":38},"2023-04-12",{"date":216,"type":21},"2026-12-31",{"name":44,"class":45},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":22,"phases":227,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":105},"100555587","phase-2-study-of-bebt-109-in-subjects-with-non-small-cell-lung-cancer-carrying-egfr-exon-20-insertion-mutations-100555587","NCT06514027","Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations","Inclusion Criteria:\n\n1. Participants have a comprehensive understanding, voluntarily sign the Informed Consent Form (ICF), and are capable of completing all trial procedures;\n2. Age ≥18 years old, both males and females are eligible;\n3. According to the 8th edition of the American Joint Committee on Cancer（AJCC）TNM staging criteria for lung cancer: patients with histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC) that is unresectable and intolerant or refuses radical synchronous radiochemotherapy, with locally advanced (stage IIIB or IIIC), recurrent, or metastatic (stage IV) disease;\n4. No prior systemic treatment for locally advanced (stage IIIB or IIIC) or recurrent\u002Fmetastatic (stage IV) NSCLC. Note: 1) Neoadjuvant\u002Fadjuvant therapy is allowed as long as it has been completed at least 6 months before the disease is diagnosed as locally progressive or metastatic tumor; 2) Participants who have failed treatment with savolitinib in the past are allowed;\n5. EGFR exon 20 insertion mutations confirmed by peripheral blood or tumor tissue testing conducted by a tertiary hospital or a qualified third-party testing agency, and records must be provided. Patients may have only EGFR exon 20 insertion mutations or may also have other EGFR or HER2 mutations;\n6. At least one measurable lesion that meets the RECIST V1.1 criteria during the screening period. Lesions previously treated with radiotherapy cannot be used as target lesions unless there is clear radiological progression after radiotherapy;\n7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1, and no decline in performance status within two weeks before the screening period, with an expected survival time ≥12 weeks;\n8. Provided that the subject has not received blood transfusion, erythropoietin, recombinant human thrombopoietin, or colony-stimulating factor treatment within 14 days before the screening period, laboratory tests indicate that the subject has adequate organ function, including:\n\n   * Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL; Platelet count (PLT) ≥100×10\\^9\u002FL; Hemoglobin (HGB) ≥90 g\u002FL;\n   * Total serum bilirubin (TBIL) ≤1.5×upper limit of normal (ULN) (for patients with Gilbert's syndrome, total bilirubin ≤3×ULN is allowed);\n   * AST and ALT ≤2.5×ULN (for those with liver metastasis, AST and ALT ≤5×ULN is allowed);\n   * Creatinine clearance ≥45 ml\u002Fmin (calculated according to the Cockcroft-Gault formula), and urine protein ≤1+ or for subjects with urine protein ≥2+, the 24-hour urine protein total is ≤1 g\u002F24 h;\n   * Activated partial thromboplastin time (APTT) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN, international normalized ratio (INR) ≤1.5×ULN;\n9. Participants with a history of liver cirrhosis have a Child-Pugh score of A or B ≤7 at screening;\n10. The QT interval evaluated by ECG at screening is normal, defined as the corrected QT interval (Fridericia) (QTcF) ≤450 ms (for males) or ≤470 ms (for females) (those not meeting the standard need to be retested twice, and the average corrected value of the three measurements is taken);\n11. Male and female participants of childbearing potential must agree to use reliable contraceptive methods (hormonal or barrier methods) during the study period and for at least 6 months after the last administration of the drug, and must not breastfeed, with a negative blood pregnancy test before the first administration.\n\nExclusion Criteria:\n\n1. History of severe allergic diseases (such as uncontrollable asthma), severe drug (including investigational drugs not yet marketed) allergies, or known allergies or intolerance to any drug or drug component in this study;\n2. Diagnosis of other primary malignant tumors besides NSCLC, except for the following: non-melanoma skin cancer or cervical carcinoma in situ that has been adequately treated and cured, non-metastatic prostate cancer, or other primary malignant tumors that have been clearly recurrence-free for at least 3 years since the last treatment and have a low potential risk of recurrence;\n3. Major surgical procedures within 28 days before the first administration of the study drug, planned surgery during the study period, or postoperative complications from surgery performed within 2 months before the first administration of the study drug (except for minor surgeries that the investigator deems do not affect participation in the trial, such as catheter placement or minimally invasive biopsy);\n4. Presence of pleural effusion, ascites, or pericardial effusion with significant symptoms or requiring drainage;\n5. Poorly controlled diabetes mellitus. Definition: Hemoglobin A1C (HbA1c) ≥8%; or 7% ≤ Hemoglobin A1C \\\u003C 8%, accompanied by clinical symptoms of diabetes, such as polyuria, polydipsia, polyphagia, and weight loss. (Subjects who have not been adequately treated to control blood sugar, after adjusting the drug treatment plan, with fasting blood glucose ≤10 mmol\u002FL, and deemed suitable to participate in this study by the investigator, can be included);\n6. Received live vaccines within 28 days before the first administration of the study drug or plan to receive any live vaccines during the study period;\n7. Subjects with a tendency to bleed or evidence of bleeding, including:\n\n   1. History of active ulcers or perforations of the stomach and duodenum within 6 months before the first dose, persistent positive fecal occult blood, history of gastrointestinal bleeding such as ulcerative colitis;\n   2. History of hemoptysis (defined as blood that is bright red or 2.5 ml) within 2 weeks before the first dose, or the presence of unhealed wounds, ulcers, or fractures;\n   3. Vasculitis;\n   4. Other conditions that may cause bleeding as determined by the investigator;\n8. Presence of severe gastrointestinal functional abnormalities that may affect the intake, transport, or absorption of the test drug (such as inability to swallow, uncontrollable vomiting, history of extensive gastrointestinal resection, chronic diarrhea, long-term use of proton pump inhibitors (PPIs) for gastric diseases, Crohn's disease, ulcerative colitis, intestinal obstruction, etc.);\n9. Presence of central nervous system (CNS) metastasis, except for those who are asymptomatic, have stable disease, and do not require drug treatment within 4 weeks before the start of the study treatment;\n10. Current spinal cord compression (symptomatic or asymptomatic, and detected by radiographic examination) or suspected meningeal disease (symptomatic or asymptomatic);\n11. Imaging (CT or MRI) shows that the tumor invades major blood vessels or is not clearly demarcated from major blood vessels;\n12. Significant clinical cardiovascular and cerebrovascular diseases within 6 months before the first study drug administration, including but not limited to:\n\n    e. Acute myocardial infarction, unstable angina; f. New York Heart Association (NYHA) class III or IV congestive heart failure; g. Left ventricular ejection fraction \\\u003C50% measured by echocardiography or multigated acquisition (MUGA) scan or with severe wall motion abnormalities; h. History of clinically significant ventricular arrhythmias (such as sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes); i. Subjects with poorly controlled hypertension, with systolic blood pressure \\>160 mmHg or diastolic blood pressure \\>100 mmHg; j. Arterial\u002Fvenous thrombotic events, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis, and pulmonary embolism; low molecular weight heparin treatment is allowed, and the use of nonsteroidal anti-inflammatory drugs (NSAIDs) or antiplatelet drugs (such as aspirin (\\>325 mg\u002Fday), clopidogrel (\\>75 mg\u002Fday), dipyridamole, ticlopidine, or cilostazol, etc.) is prohibited throughout the study period; k. Other arrhythmias deemed unsuitable for inclusion in this study by the investigator (such as third-degree atrioventricular block);\n13. Presence of other severe or uncontrolled diseases that the investigator deems unsuitable for participation in this clinical trial or may affect the subject's compliance with the study protocol, including but not limited to:\n\n    1. Interstitial lung disease, radiation pneumonitis or drug-related pneumonitis requiring steroid treatment;\n    2. History of uncontrolled hereditary or acquired thrombotic diseases;\n    3. Persistent or active infections, including but not limited to: hepatitis B virus (meeting both hepatitis B surface antigen positive or hepatitis B e antigen positive, and HBV-DNA greater than the upper limit of normal of the center's laboratory), hepatitis C virus (meeting both HCV-Ab positive and HCV-RNA positive), human immunodeficiency virus (HIV-Ab positive), syphilis non-specific antibody positive (rapid plasma reagin \\[RPR\\] or toluidine red unheated serum test \\[TRUST\\]) without clinical symptoms, or other active infections that require systemic treatment within 14 days before the first study drug administration;\n    4. Severe or unhealed wounds, ulcers, or fractures;\n14. History of drug or alcohol abuse or mental illness;\n15. Use of drugs or herbal supplements that are strong inhibitors or inducers of CYP 3A4 and CYP 2C8 within 14 days before the first administration of the study drug ;\n16. Received \\>30Gy of non-thoracic radical radiotherapy within 28 days before the first dose, \\>30Gy of thoracic radiotherapy within 24 weeks before the first dose, and ≤30Gy of palliative radiotherapy within 14 days before the first dose;\n17. Participation in another clinical trial and drug administration within 4 weeks before the first dose;\n18. Other conditions deemed unsuitable for entry into this study by the investigator.",{"count":226,"type":21},30,[24],"This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.",[230],"Non Small Cell Lung Cancer",[187,232,233,234,31,33],"EGFR exon 20 insertion mutations","Drug combination","First-line treatment","2024-07-17",{"date":237,"type":38},"2024-07-23",{"date":239,"type":21},"2024-07",{"date":241,"type":21},"2027-11",{"name":44,"class":45},""]