[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"endometrioid-endometrial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:endometrioid-endometrial-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":34,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100480932","phase-1-onc201-and-atezolizumab-in-obesity-driven-endometrial-cancer-100480932",false,"NCT05542407","ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer","Phase 1 Clinical Trial of ONC201 and Atezolizumab in Obesity-Driven Endometrial Cancer","In order to participate in this study a subject must meet all of the eligibility criteria outlined below.\n\nInclusion Criteria\n\n1. Ability to understand and willingness to sign a written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.\n2. Age ≥ 18 years at the time of consent.\n3. ECOG Performance Status of 0, 1, or 2\n4. Histologically confirmed metastatic or recurrent EC (endometrioid, carcinosarcoma, serous, clear cell, adeno-squamous and mixed histologies).\n5. Subjects must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension in accordance with RECIST criteria\n6. Must have radiographic disease progression after at least 1 line of systemic cytotoxic therapy for metastatic disease or with progression within 12 months of completing adjuvant chemotherapy.\n7. Life expectancy of at least 3 months.\n8. Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained within 72 hours prior to initiating study treatment.\n\nExclusion Criteria\n\n1. Prior treatment with ONC201.\n2. Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, and anti PD-L1 therapeutic antibodies\n3. Treatment with another investigational agent or participation in another clinical trial within the last 28 days prior to initiating protocol therapy.\n4. Subjects who have had chemotherapy or radiotherapy within 4 weeks prior to study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to initiating protocol therapy.\n5. Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of protocol therapy Subjects receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.\n6. Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \\[IL-2\\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of protocol therapy.\n7. Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti TNF-agents) within 2 weeks prior to initiation","FEMALE","18 Years",{"count":19,"type":20},58,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Endometrial cancer (EC) is the fourth most common cancer in United States women, and alarmingly, the frequency and mortality from EC continues to rise, in part due to the obesity epidemic. Obese women with EC have a 6.3-fold increased risk of death from this disease, as compared to their non-obese counterparts. Patients with advanced\u002Frecurrent EC are unlikely to be cured by surgery, conventional chemotherapy (paclitaxel + carboplatin is the standard first-line treatment), radiation, or a combination of these. Thus, new treatments for EC are desperately needed as well as a better understanding of the impact of obesity on EC biology and treatment.\n\nThe purpose of this study is to test the safety of a combination of treatments, atezolizumab and ONC201, given based on body weight, to treat endometrial cancer. Using the combination of atezolizumab and ONC201, has not been approved by the Food and Drug Administration (FDA) for the treatment of endometrial cancer. This clinical trial will examine the treatment of atezolizumab + ONC201 in obese and non-obese subjects with metastatic\u002Frecurrent EC.",[26,27,28,29,30,31,32,33],"Endometrial Cancer","Metastasis","Endometrioid Endometrial Cancer","Carcinosarcoma","Serous Adenocarcinoma of Endometrium (Diagnosis)","Clear Cell Endometrial Carcinoma","Endometrial Endometrioid Adenocarcinoma","Endometrial Mixed Cell Adenocarcinoma",[35,36,37],"Atezolizumab","ONC201","obesity","RECRUITING","2026-01-27",{"date":41,"type":42},"2026-01-29","ACTUAL",{"date":44,"type":42},"2023-10-23",{"date":46,"type":20},"2028-07-31",{"name":48,"class":49},"UNC Lineberger Comprehensive Cancer Center","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":50},"100559221","phase-2-clinical-efficacy-study-of-pd-1-inhibitor-combined-with-neoadjuvant-chemotherapy-in-advanced-endometrial-cancer-100559221","NCT06561308","Clinical Efficacy Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer","A Single-arm, Multicenter Phase II Study of PD-1 Inhibitor Combined With Neoadjuvant Chemotherapy in Advanced Endometrial Cancer in Clinical Efficacy","Inclusion Criteria:\n\n1. Endometrial cancer initially diagnosed as stage III non-operable resectable, stage IV (FIGO, 2009 criteria) after imaging evaluation\n2. Pathologically confirmed endometrial cancer that looks like endometrial carcinoma\n3. Patient age ≥18 years and ≤75 years old\n4. ECOG status score of 0-1\n5. tolerate surgery and radiotherapy\n6. Laboratory tests: WBC ≥3.5×109\u002FL, NEU ≥1.5×109\u002FL, PLT ≥80×109\u002FL, serum ≥80×109\u002FL, serum ≥80×109\u002FL, serum ≥80×109\u002FL, serum ≥80×109\u002FL.\n\n   ×109\u002FL, serum bilirubin ≤1.5 times the high limit of normal value, transaminase ≤1.5 times the high limit of normal value, BUN ≤1.5 times the high limit of normal value.\n\n   1.5 times of the high limit of normal value, BUN, Cr≤normal value;\n7. Able to follow up and good compliance;\n8. Able to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and the program.\n\nExclusion Criteria:\n\n1. Subjects with an active, known, or suspected autoimmune disease, or a history of an autoimmune disease, except for: vitiligo, alopecia areata, Graves' disease, psoriasis, or eczema that has not required systemic therapy within the last 2 years, hypothyroidism that is asymptomatic or requires only stable doses of hormone replacement therapy (due to autoimmune thyroiditis), type 1 diabetes that requires only stable doses of insulin replacement therapy, asthma that subsides completely in childhood and does not require intervention in adulthood, or diseases that do not recur in the absence of external triggers;\n2. Prior treatment with immune checkpoint inhibitors, including, but not limited to, other anti-PD-1, anti-PD-L1 antibodies, CTLA-4 antibodies, or any treatment directed against immune co-stimulators (e.g., antibodies directed against ICOS, CD40, CD137, GITR, OX40 targets, etc.) that target any mechanism of immune action against tumors;\n3. Known hypersensitivity to any component and\u002For any excipient of the trial regimen;\n4. Immunosuppressive drugs or systemic corticosteroids for immunosuppression (\\>10 mg\u002Fday of prednisone or other equivalent) within 2 weeks prior to trial dosing; topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are permitted;\n5. Received herbs with antitumor effects or drugs with immunomodulatory effects (e.g., thymidine, interferon, interleukin-2) within 2 weeks prior to the trial;\n6. Active systemic infection requiring systemic treatment;\n7. Serious infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia;\n8. Patients with untreated chronic hepatitis B, or HBV carriers with chronic hepatitis B virus (HBV) DNA greater than 1,000 IU\u002FmL, or patients with active hepatitis C. Inactive HBsAg carriers, treated hepatitis B patients with stable disease (HBV DNA \\\u003C 1000 IU\u002FmL), and cured hepatitis C patients will be eligible for enrollment. HCV antibody-positive subjects will be eligible for the study only if they have a negative HCV RNA test;\n9. Known active tuberculosis (TB), patients with suspected active TB should undergo chest X-ray and sputum examination in conjunction with clinical signs and symptoms for exclusion;\n10. Immunodeficiency or human immunodeficiency virus (HIV antibody positive);\n11. Subjects with active inflammatory bowel disease or a history of such disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea). Subjects who are unable to swallow or who have malabsorption syndrome, uncontrolled nausea, vomiting, diarrhea, or other gastrointestinal disorders that severely interfere with drug intake and absorption;\n12. Known interstitial lung disease that is symptomatic or may interfere with detection or treatment of immune-associated pneumonia;\n13. Treatment with a live or attenuated vaccine administered within 4 weeks prior to the first trial dose, inactivated seasonal influenza virus vaccine is permitted;\n14. Patients who have received a prior allogeneic bone marrow transplant or solid organ transplant;\n15. History of primary malignant tumor within the last 5 years;\n16. Subjects who have undergone major surgery (e.g., open abdomen, open chest, organ resection, etc.) and severe trauma within 28 days prior to the first dose of implantable infusion devices are permitted;\n17. Subjects with a history of gastrointestinal perforation, gastrointestinal fistula, or female genital fistula;\n18. Uncontrolled other co-morbidities, symptoms, or medical history, including: (1) Persons with one of the following cardiovascular diseases or cardiovascular risk factors: myocardial infarction, unstable angina pectoris, pulmonary embolism, acute\u002Fcontinuous myocardial ischemia, cerebral vascular accident, transient ischemic attack, theor other clinically significant\u002Frequired drug intervention arterial or venous thrombosis, embolism or cerebral ischemic events; symptoms of congestive heart failure (NYHA class III or higher) within 6 months (ii) clinically significant bleeding symptoms or a history of significant bleeding characteristics, such as gastrointestinal bleeding, gastric ulcer bleeding, or vasculitis, within 1 month prior to the first dose; (iii) clinically active hemoptysis, active diverticulitis, abdominal abscess, and gastrointestinal obstruction; (iv) uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; (v) abnormalities of hepatic or renal development, or a history of surgery;\n19. Female patients who are pregnant or breastfeeding; women of childbearing age who refuse to accept contraceptive measures during neoadjuvant immunotherapy;\n20. Concurrent participation in other interventional clinical trials; participation in observational and non-interventional clinical trials is permitted;\n21. Any condition that, in the opinion of the Investigator, may result in risk in the receipt of the study drug or that would interfere with the evaluation of the safety of the study drug or the interpretation of the study results. In the judgment of the Investigator, it is unlikely that Patients who, in the judgment of the Investigator, are less likely to comply with the study steps, restrictions, and requirements shall not be permitted to participate in this study.","75 Years",{"count":60,"type":20},39,[62],"PHASE2","Exploring the therapeutic effect of neoadjuvant chemotherapy combined with PD-1 inhibitor camrelizumab on advanced stage III-IV endometrial cancer",[28],[66,67],"Neoadjuvant chemotherapy","PD-1 inhibitor (Camrelizumab)","2025-11-22",{"date":70,"type":42},"2025-12-01",{"date":72,"type":42},"2025-09-01",{"date":74,"type":20},"2031-12-01",{"name":76,"class":49},"Women's Hospital School Of Medicine Zhejiang University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":84,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":112},"100515861","phase-2-trial-of-nab-sirolimus-in-combination-with-letrozole-in-patients-with-advanced-or-recurrent-endometrioid-endometrial-cancer-100515861","NCT05997017","Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer","A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer","Inclusion Criteria:\n\n1. Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is suggested but not required.\n2. All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging \\[MRI\\] if CT scans are contraindicated) as defined by RECIST version 1.1.\n3. Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.\n4. Prior treatment history:\n\n   1. Adjuvant setting - treatment with chemotherapy, hormonal therapy,checkpoint inhibitors, and\u002For other therapy is permitted as long as theadjuvant therapy ended ≥6 months from enrollment.\n   2. Recurrent\u002Fadvanced\u002Fmetastatic setting - treatment with 0-1 prior chemotherapy regimens is permitted (patients may be naïve to chemotherapy); chemotherapy must have been completed ≥3 months prior to enrollment. Patients are permitted to have received adjuvant chemotherapy and no more than 1 line of chemotherapy in the recurrent\u002Fadvanced\u002Fmetastatic setting.\n   3. Non-chemotherapy-based treatment (eg, checkpoint inhibitors, hormonal therapy, and\u002For small molecule agents) is permitted at any point as long as therapy ended ≥4 weeks prior to enrollment.\n   4. Patients who have received prior therapy in the recurrent\u002Fadvanced\u002Fmetastatic setting must have achieved a complete or partial response(investigator-assessed) to at least 1 therapy.\n5. Age: 18 years or older.\n6. Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate liver function:\n\n   1. Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome, then ≤3 × ULN)\n   2. Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)\n8. Adequate renal function: creatinine clearance (CrCL) ≥30 mL\u002Fmin based on Cockcroft-Gault\n9. Adequate hematologic parameters:\n\n   1. Absolute neutrophil count (ANC) ≥1.0 × 109\u002FL (growth factor support allowed)\n   2. Platelet count ≥100,000\u002Fmm3 (100 × 109\u002FL) (transfusion and\u002For growth factor support allowed)\n   3. Hemoglobin ≥8.0 g\u002FdL (transfusion and\u002For growth factor support allowed)\n10. Fasting serum triglyceride must be ≤300 mg\u002FdL; fasting serum cholesterol must be less than or equal to 350 mg\u002FdL.\n11. Minimum of 4 weeks since any major surgery, completion of radiation, or completion of prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1.\n12. Non-pregnant and non-breastfeeding female:\n\n    1. Females of childbearing potential must agree to use effective contraception or abstinence without interruption from 28 days prior to starting nab-Sirolimus through 3 months after the last dose of nab-Sirolimus and have a negative serum pregnancy test (beta human chorionic gonadotropin \\[β-hCG\\]) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.\n    2. Sexual abstinence is considered a highly effective contraceptive method only if defined as refraining from heterosexual intercourse from 28 days prior to starting study medication throughout 3 months after last dose of study medication. The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.\n13. The patient understands and signs the informed consent.\n14. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.\n15. Patients with a known history of human immunodeficiency virus (HIV)infection are eligible if:\n\n    1. There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.\n    2. The patient has been receiving an antiretroviral therapy regimen for≥4 weeks and the HIV viral load is \\\u003C400 copies\u002FmL prior to enrollment.\n    3. Antiretroviral therapy regimen does not include strong cytochrome(CYP)3A4 inhibitors or inducers\n\nExclusion Criteria:\n\n1. Prior treatment with an mTOR inhibitor, including nab-sirolimus.\n2. Patients with known inactivating TSC1 or TSC2 alterations (based on tissue or liquid next generation sequencing \\[NGS\\]) unless the PRECISION 1 study (NCT05103358) has been closed to enrollment.\n3. Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.\n4. Patients with primary refractory disease (ie, those who have never achieved a complete or partial response to prior therapy) are not permitted on study.\n5. Patients with the following are excluded:\n\n   1. Known or suspected brain metastases.\n   2. Severe heart disease defined as unstable angina pectoris, New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease.\n   3. Severe lung disease defined as a diffusing capacity for carbon monoxide (DLCO) that is ≤50% of normal predicted value and\u002For an O2 saturation ≤88% at rest on room air (Note: spirometry and pulmonary function tests \\[PFTs\\] are not required to be performed unless clinically indicated).\n   4. Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy.\n   5. A history of malignancies other than the one under treatment unless the patient is disease-free for more than 5 years from completion of therapy administered with curative intent. Controlled non-melanoma skin cancers, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low grade hematologic malignancies (eg, chronic lymphocytic leukemia \\[CLL\\], follicular lymphoma, etc), or other adequately treated carcinoma in situ may be eligible, after discussion with the Medical Monitor.\n   6. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg\n   7. Patients with history of interstitial lung disease and\u002For pneumonitis, or pulmonary hypertension.\n   8. Active hepatitis B and\u002For hepatitis C infection and detectable viral load despite antiviral therapy\n6. Required use of concomitant medications with strong CYP3A4 interactions (induction or inhibition) should be discontinued (strong inhibitors include ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin, telithromycin; strong inducers include rifampin and rifabutin). These agents must be discontinued prior to first dose of nab-sirolimus.","ALL",{"count":86,"type":20},29,[62],"A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer",[26,90,91,92,93,28],"Endometrioid Tumor","Cancer","Tumor","Recurrent Endometrial Carcinoma",[95,96,97,98,99,100,101,90,26,93,28],"nab-Sirolimus","FYARRO","Letrozole","Endometrial","Recurrent","ABI-009","Endometrial Carcinoma","2025-11-12",{"date":104,"type":42},"2025-11-13",{"date":106,"type":42},"2023-12-28",{"date":108,"type":20},"2027-06",{"name":110,"class":111},"Aadi Bioscience, Inc.","INDUSTRY",9]