[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-endometrial-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-endometrial-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,55,92,117,138,155,183],{"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":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":4},"100644293","phase-1-a-phase-1-study-to-evaluate-the-safety-and-efficacy-of-opb-201-in-recurrent-endometrial-and-platinum-resistant-ovarian-cancer-100644293",false,"NCT07664735","A Phase 1 Study to Evaluate the Safety and Efficacy of OPB-201 in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","A Phase 1a\u002Fb Study to Evaluate the Safety and Efficacy of OPB 201, an Autologous PReferentially Expressed Antigen of MElanoma (PRAME) T Cell Receptor (TCR) T Cell Therapy in Recurrent Endometrial and Platinum-resistant Ovarian Cancer.","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at the time of signing the informed consent form.\n2. Histologically confirmed diagnosis of endometrial cancer, epithelial ovarian, peritoneal, or fallopian tube cancer based on local histopathological findings.\n3. Received at least 1 prior line of systemic chemotherapy including a platinum-based chemotherapy.\n4. Received prior therapy with a PARP inhibitor if the subject has a known germline or somatic BRCA1\u002F2 mutation.\n5. Measurable disease.\n6. Consent to provide archived tumor tissue sample.\n7. ECOG performance status of 0 or 1.\n8. Adequate organ function.\n9. HLA-A \\*02:01 or HLA-A \\*02:02\n10. PRAME positive tumor\n\nExclusion Criteria:\n\n1. Women of child-bearing potential who are pregnant or breastfeeding.\n2. Uncontrolled bacterial, fungal, or viral infections.\n3. Active infection requiring systemic therapy.\n4. Bleeding or thrombotic disorders or at risk for severe hemorrhage.\n5. Any form of primary immunodeficiency.\n6. Had an allogenic tissue\u002Fsolid organ transplant.\n7. Active autoimmune disease.\n8. Concurrent treatment with systemic high dose corticosteroids.\n9. Unresolved acute effects of any prior therapy.\n10. Other exclusions as stated in the protocol.","FEMALE","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if OPB-201 is safe in recurrent endometrial and platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-201. Participants will have their own T cells modified in a laboratory and given back to them as OPB-201 in this one-time treatment. Participants will be in the hospital when they receive OPB-201 and then be checked at the clinical site frequently for the first few months.",[26,27,28,29,30,31,32],"Endometrial Cancer Recurrent","Endometrial Cancer","Advanced Endometrial Cancer","Ovarian Cancer","Ovarian Cancer Recurrent","Platinum Resistant Ovarian Cancer","Endometrial Cancers",[34,35,36,37,38,39,40,41,42],"Outpace","Ovarian cancer","Endometrial cancer","advanced ovarian cancer","advanced endometrial cancer","cell therapy","TCR-T","TCR","PRAME directed TCR","NOT_YET_RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-24","ACTUAL",{"date":49,"type":20},"2026-06-30",{"date":51,"type":20},"2030-09",{"name":53,"class":54},"Outpace Bio, Inc.","INDUSTRY",{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":5},"100558186","phase-1-a-study-of-mov18-ige-in-patients-with-solid-tumours-that-express-folate-receptor-alpha-100558186","NCT06547840","A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha","A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha","Inclusion criteria:\n\nPatients must meet all of the following criteria:\n\n1. Female ≥18 years of age.\n2. Written (signed and dated) informed consent.\n3. Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous\u002Fendometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:\n\n   * HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+\n   * ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines\n4. Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).\n\n   Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.\n\n   Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.\n5. Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.\n\n   Note: this test will be performed at a reference laboratory.\n6. Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).\n7. Prior therapies:\n\n   Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.\n\n   Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n8. Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.\n\n   ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.\n9. No evidence of bowel obstruction.\n10. ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.\n11. Estimated life expectancy of \\>3 months, in the opinion of the Investigator.\n12. Adequate haematological function, including all of the following:\n\n    i. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (\\>1,500\u002Fmm3). G-CSF or GM-CSF may not be used to achieve this level.\n\n    ii. Platelets ≥100 × 109\u002FL (\\>100,000 per mm3) iii. Haemoglobin level \\>9 g\u002FdL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g\u002FdL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.\n\n    iv. Adequate coagulation function at screening as determined by prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) or international normalised ratio (INR) \\\u003C1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Does not apply to patients on an anti coagulant with a stable dose within 28 days prior to first dose.\n\n    v. Lymphocyte count ≥1000 cells\u002Fmm3, (1.0x10\\*9\u002FL)\n13. Intact immune system as demonstrated by CD4 count ≥500 cells\u002Fmm3 and CD8 count ≥150 cells\u002Fmm3.\n14. Adequate renal function as demonstrated by either estimated glomerular filtration rate \\[eGFR\\] or calculated creatinine clearance \\>45 mL\u002Fmin (Cockcroft Gault equation: creatinine clearance: (140-age \\[years\\]) × weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) × 0.85 ≤1.5 × ULN, or ≥60 mL\u002Fmin for a patient with creatinine levels \\>1.5 × institutional ULN.\n15. Adequate hepatic function:\n\n    i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \\>1.5 × ULN.\n\n    ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n\n    iii. Albumin ≥3.0 g\u002FdL.\n16. Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).\n17. No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.\n18. No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and\u002For no history of autoimmune disease that required treatment with steroids or immunosuppressive medication within 6 months of the first administration of MOv18 IgE.\n19. Negative serum or urine pregnancy test.\n20. Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy.\n21. Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months, (182 days), following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.\n22. Willing and able to comply with all protocol-specified assessments and the trial visit schedule.\n23. Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18 IgE.\n\nExclusion criteria:\n\nPatients must not meet any of the following criteria:\n\n1. Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).\n2. Presence of ascites\u002Fpleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.\n3. Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants\u002FMAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.\n\n   i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion\n4. History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.\n5. History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.\n6. Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng\u002FmL.\n7. Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.\n8. Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).\n9. Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.\n10. Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (\\>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.\n11. Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.\n12. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n13. Historical positive serology test for human immunodeficiency virus (HIV).\n14. History of interstitial lung disease or active pneumonitis.\n15. Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).\n16. Positive serology for hepatitis B or C.\n17. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.\n18. Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.\n19. Concomitant use of drugs known to prolong QT\u002FQTc interval (Appendix 1).\n20. Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.\n21. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.\n22. Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.\n23. Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.\n24. Currently breastfeeding.\n25. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the trial\n26. Patient is under legal custodianship.\n27. First-degree relatives of the Investigator, trial staff or Sponsor employees.",{"count":63,"type":20},45,[23],"EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer\n\nThe dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).\n\nPart 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.",[67,68,69,70,27,28],"Advanced Ovarian Cancer","Platinum-resistant Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Triple -Negative Breast Cancer",[72,73,74,75,76,77,78,79,80,81],"Ovarian","Cancer","Resistant","IgE","Advanced","Platinum","Folate Receptor alpha","Antibody","Endometrial","Triple Negative Breast","RECRUITING","2026-03-31",{"date":85,"type":47},"2026-04-06",{"date":87,"type":47},"2024-09-03",{"date":89,"type":20},"2027-03",{"name":91,"class":54},"Epsilogen Ltd",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":101,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100447941","phase-2-study-of-envafolimab-alone-or-with-lenvatinib-in-patients-with-advanced-endometrial-cancer-100447941","NCT05112991","Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","An Open-label, Multi-center, Multi-corhort Phase II Study of Envafolimab Alone or With Lenvatinib in Patients With Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Volunteer to participate and sign the informed consent form.\n2. Has a histologically confirmed diagnosis of endometrial carcinoma (EC). Has Documented evidence of advanced, recurrent or metastatic EC and are not candidates for curative surgery or radiation.\n3. Failure or intolerance of standard first-line platinum-based chemotherapy regimen for EC.\n\n   Note: If recurrence occurs during adjuvant\u002Fneoadjuvant therapy or within 12 months after completion, adjuvant\u002Fneoadjuvant therapy is considered to be the first-line treatment for advanced disease. There is no restriction regarding prior hormonal therapy.\n4. Has at least 1 measurable target lesion according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and confirmed by Blind Independent Imaging Review Committee (BIRC).\n5. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Life expectancy of 12 weeks or more.\n7. Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 14 days before the first study drug treatment).\n8. Archival tumor tissue or a newly obtained biopsy must be available prior to the first dose of study drug for biomarker analysis. Tissue samples need to be from lesions that have not received local radiotherapy.\n9. Females of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug.\n\nExclusion Criteria:\n\n1. Previous lab results showed dMMR or MSI-H.\n2. Participate in the clinical trials of other investigational drugs within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy or targeted therapy.\n3. The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level.\n4. Recieved major surgery with 28 days before the first medication or has serious nonhealing wound, ulcer, or bone fracture at screening.\n5. Has received prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.\n6. Uncontrolled blood pressure (BP) with or without antihypertensive medications, defined as BP \\>150\u002F90 mmHg.\n7. Uncontrolled or major Cardio-cerebral vascular disease.\n8. Have active, or have had autoimmune diseases or risks that may recur. However, subjects required only replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) or with skin diseases that do not require systemic treatmentare are allowed to be included.\n9. Subjects who need to use corticosteroids (\\> 10 mg\u002Fday prednisone equivalent dose) for systemic therapy within 14 days before the study drug is administered.\n10. Has received a live-virus vaccination within 28 days of planned treatment start or plan to reveived a live-virus vaccination during the study.\n11. Has current or suspected (non-infectious) pneumonitis.\n12. Active infection (any infection requiring systemic treatment).\n13. Has active Hepatitis B or C.\n14. Is positive for Human Immunodeficiency Virus (HIV).\n15. Has uncontrolled pericardial effusion, pleural effusion or ascites.\n16. Has symptomatic\u002Factive brain metastasis or meningeal carcinomatosis; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.\n17. Suffered from other known malignant tumors within 5 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and\u002For carcinoma in situ after radical resection).\n18. Hypersensitivity to either of the study drug or its components.\n19. Females who are pregnant or breastfeeding and who refuse to use a highly effective method of contraception throughout the entire study period, and for 6 months after the last dose of study drug;\n20. According to the judgement of the investigators, there are other factors indicate that the subject should not be enrolled.\n21. Has received prior treatment with any treatment targeting VEGF-directed angiogenesis.\n22. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n23. Has a history of hypertensive crisis or hypertensive encephalopathy.\n24. Has gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n25. Has a history of serious bleeding disease within 6 months prior to the first dose of study drug.",{"count":100,"type":20},108,[102],"PHASE2","This is an open-label, multi-center, multi-corhort Phase II study of Envafolimab alone or with Lenvatinib in patients with advanced endometrial cancer.The primary objective is to evaluate objective response rate of envafolimab alone or with lenvatinib.",[28],[106],"endometrial cancer","2026-03-23",{"date":109,"type":47},"2026-03-25",{"date":111,"type":47},"2022-03-04",{"date":113,"type":20},"2026-12",{"name":115,"class":54},"3D Medicines (Sichuan) Co., Ltd.",19,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":21,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100445190","phase-3-efficacy-and-safety-of-a-repurposed-drug-added-to-the-combination-of-len-plus-pem-in-advanced-endometrial-cancer-100445190","NCT05077215","Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer","A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR.\n2. Documented evidence of advanced (Stage III or IV), or recurrent EC.\n3. Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation\n4. Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.\n5. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n6. Is a candidate for initiation of treatment with the combined regimen of Keytruda plus Lenvima (Len+Pem) at the doses specified as the Len+Pem Regimen (per Labeling August 2021).\n7. Life expectancy of 12 weeks or more.\n8. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days of starting study treatment.\n9. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose of study treatment.\n10. Adequate renal function defined as creatinine less than or equal to 1.5 × ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL\u002Fmin per the Cockcroft and Gault formula with creatinine levels greater than 1.5 × ULN.\n\nAdditional detail upon request.\n\nExclusion Criteria:\n\n1. Brain metastasis: Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.\n2. Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.\n3. Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.\n4. Prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.\n5. Participants must have recovered adequately from any toxicity and\u002For complications from major surgery prior to starting therapy.\n6. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g\u002F24-hour will be ineligible.\n7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of the study drugs\n8. Has a pre-existing greater than or equal (\\>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.\n9. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n10. Has clinically significant tumor bleeding within 2 weeks prior to the first dose of study treatment.\n\nAdditional detail upon request.",{"count":125,"type":20},450,[127],"PHASE3","This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).\n\nApproximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:\n\n* Diagnosis Classification (advanced Stage III\u002FIV vs. recurrent endometrial cancer)\n* ECOG score at baseline (0 vs 1)\n* Geographic region (Asia vs ROW)",[28],"2025-12-02",{"date":132,"type":47},"2025-12-08",{"date":113,"type":20},{"date":135,"type":20},"2027-12",{"name":137,"class":54},"Evergreen Therapeutics, Inc.",{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":21,"phases":147,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":150,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":154,"locationsCount":4},"100447414","phase-2-safety-lead-in-study-of-a-repurposed-drug-added-to-the-combination-of-len-plus-pem-100447414","NCT05106127","Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem","A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab","Inclusion Criteria:\n\n1. Female, 18 years and older at the time of informed consent, who has a histologically confirmed diagnosis of endometrial carcinoma, endometroid histology, that is not MSI-H or dMMR ).\n2. Documented evidence of advanced (Stage III or IV), or recurrent EC.\n3. Must have a recurrence or progressed on a platinum containing chemotherapy regimen and are not candidates for curative surgery or radiation\n4. Has historical or fresh tumor biopsy specimen for confirmation of mismatch repair (MMR) status as not MSI-H or dMMR.\n5. Has measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors (RECIST v1.1).\n6. Is a candidate for initiation of treatment with the combined regimen of Keytruda plus Lenvima (Len+Pem) OR IS CURRENTLY RECEIVING a tolerated regimen of Len+Pem at the doses specified as the Len+Pem Regimen (per Labeling July 2021)\n7. Life expectancy of 12 weeks or more.\n8. Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 within 7 days of starting study treatment.\n9. Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to 150\u002F90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the Cycle 1 Day 1.\n10. Adequate renal function defined as creatinine less than or equal to 1.5 × ULN (upper limit of normal) or calculated creatinine clearance greater than or equal to 40 mL\u002Fmin per the Cockcroft and Gault formula with creatinine levels greater than 1.5 × ULN.\n\nAdditional detail upon request.\n\nExclusion Criteria:\n\n1. Brain metastasis: Previously treated CNS disease needs to be asymptomatic and does not require steroids. Brain metastases must be asymptomatic, fully treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.\n2. Has carcinosarcoma (malignant mixed mullerian tumor), serous carcinoma, endometrial leiomyosarcoma and endometrial stromal sarcomas.\n3. Has failed treatment of lenvatinib + pembrolizumab in prior lines of therapy.\n4. Except for the allowance of ongoing use of Len+Pem, the protocol excludes patients having received any other prior anticancer treatment within 28 days (or 5 times the half-life time, whichever is shorter) or any investigational agent within 30 days prior to the first dose of study drugs. All acute toxicities related to prior treatments must be resolved to Grade less than or equal to 1.\n5. Participants must have recovered adequately from any toxicity and\u002For complications from major surgery prior to starting therapy.\n6. Participants having greater than 1+ proteinuria on urinalysis will undergo 24-h urine collection for quantitative assessment of proteinuria. Participants with urine protein greater than or equal to 1 g\u002F24-hour will be ineligible.\n7. Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of the study drugs\n8. Has a pre-existing greater than or equal (\\>=) Grade 3 gastrointestinal or non-gastrointestinal fistula.\n9. Has radiographic evidence of major blood vessel invasion\u002Finfiltration.\n10. Has clinically significant tumor bleeding within 2 weeks prior to the first dose of study treatment.\n\nAdditional detail upon request.",{"count":146,"type":20},28,[102],"This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.\n\nA safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.",[28],{"date":132,"type":47},{"date":152,"type":20},"2026-08",{"date":89,"type":20},{"name":137,"class":54},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":162,"minAge":17,"maxAge":163,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100574382","phase-1-a-study-to-evaluate-the-safety-and-efficacy-of-hb0025-injection-in-patients-with-advanced-solid-tumor-100574382","NCT06758557","A Study to Evaluate the Safety and Efficacy of HB0025 Injection in Patients With Advanced Solid Tumor","A Multicenter, Open Phase Ib\u002FII Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of HB0025 Injection Combined With Chemotherapy in Patients With Advanced Solid Tumor","Inclusion Criteria:\n\n1. Male or female, age between 18-75 years old (include 18- and 75-year-old);\n2. Be able to fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the clinical research and follow-up visit procedures；\n3. Dose escalation phase 3.1 Non-small cell lung cancer and meet all following conditions； 3.1.1 Non-small cell lung cancer (NSCLC) confirmed by histology or cytology; 3.1.2 Not suitable for surgical resection, recurrence, metastasis, or locally advanced stage; 3.1.3 Patients with tyrosine kinase inhibitor (TKI) drug sensitivity mutations of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) translocation, who have experienced disease progression after standard treatment with TKI targeted drugs, or are intolerant to standard treatment with TKI targeted drugs; 3.1.4 No known ROS proto-oncogene 1 (ROS1), neurogenic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), RET mutations or other oncogenic driver gene mutations, and there are approved therapeutic drugs for the above gene mutations (there are therapeutic drugs for genomic changes).\n\n   3.2 Endometrial cancer and meet all following conditions 3.2.1 Endometrial cancer confirmed by histology or cytology, the pathological types include but are not limited to endometrioid carcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, and carcinosarcoma; 3.2.2 Not suitable for surgical resection, recurrence, metastasis, locally advanced stage; 3.2.3 No previous systemic anti-tumor treatment (excluding adjuvant therapy and neoadjuvant therapy);\n4. Dose expansion phase 4.1 Non-small cell lung cancer and meet all following conditions 4.1.1 Non-squamous non-small cell lung cancer (Nonsq-NSCLC) or squamous non-small cell lung cancer (Sq-NSCLC) confirmed by histology or cytology (for central squamous cell carcinoma, the investigator and the sponsor jointly decide whether to enroll based on the risk of bleeding and the benefit-risk ratio of the subject); 4.1.2 Not suitable for surgical resection, recurrent, metastatic, locally advanced; Negative for TKI drug sensitivity mutations of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation; 4.1.3 Negative for TKI drug sensitivity mutations of epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) translocation; 4.1.4 No known ROS proto-oncogene 1 (ROS1), neurogenic tyrosine receptor kinase (NTRK)，proto-oncogene B-raf (BRAF), RET mutations or other oncogenic driver gene mutations, for which there are approved therapeutic drugs for the above gene mutations (there are therapeutic drugs for genomic changes); 4.1.5 No previous systemic anti-tumor treatment (for subjects who have received adjuvant\u002Fneoadjuvant treatment for non-metastatic disease with the purpose of cure, if disease progression occurs within 6 months of the end of the last treatment, the treatment regimen is considered as one systemic treatment and is not allowed to be included).\n\n   4.2 Endometrial cancer and meet all following conditions 4.2.1 Endometrial cancer confirmed by histology or cytology, with pathological types including but not limited to endometrioid carcinoma, serous carcinoma, clear cell carcinoma, undifferentiated carcinoma, dedifferentiated carcinoma, mixed carcinoma, and carcinosarcoma; 4.2.2 Not suitable for surgical resection, recurrence, metastasis, locally advanced stage; 4.2.3 No previous systemic anti-tumor treatment (for subjects who have received adjuvant\u002F neoadjuvant treatment for non-metastatic disease with the purpose of cure, if disease progression occurs within 6 months of the end of the last treatment, the treatment regimen is considered as 1 systemic treatment and is not allowed to be included in the group);\n5. Patients who have not received anti-tumor treatment or other clinical trial drugs within 4 weeks before the first administration of HB0025 (for small molecule targeted drugs, this is within 2 weeks before the first use of the study drug or within 5 half-lives of the drug (whichever is longer); have completed systemic palliative radiotherapy for at least 4 weeks or local palliative radiotherapy for at least 2 weeks (in the baseline tumor assessment, the target lesions defined can be excluded if they are not in the local radiotherapy area); have not systematically used (for 2 consecutive weeks) traditional Chinese medicine with anti-tumor indications within 2 weeks before the first use of the study drug;\n6. There is at least one measurable tumor lesion (according to RECIST 1.1 standard); Note: Lesions that have been previously treated with local therapy (e.g., radiofrequency ablation, anhydrous ethanol or acetic acid injection, cryoablation, high-intensity focused ultrasound, trans-arterial chemoembolization, local radiotherapy, etc.) are not considered measurable lesions unless there is clear progression.\n7. ECOG score of 0 or 1;\n8. The expected survival period is not less than 12 weeks;\n9. The following laboratory indicators must be met:\n\n   9.1 Absolute neutrophil count ≥1.5×10⁹\u002FL; 9.2 Platelet count ≥90×10⁹\u002FL; 9.3 Hemoglobin ≥90 g\u002FL; Note: The above three requirements require that the patient has not received any blood component or cell growth factor support therapy within two weeks before blood collection.\n\n   9.4 Creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault Formula); 9.5 Total bilirubin ≤1.5×ULN; 9.6 Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5× ULN; If the investigator determines that the increase is due to liver metastasis of the tumor, ALT和AST≤5×ULN; 9.7 Prothrombin time (PT)≤1.5×ULN, partial thromboplastin time (APTT)≤1.5×ULN; 9.8 Urine dipstick test results show protein in urine\\\u003C1+; if urine protein ≥1+, 24-hour urine protein content\\\u003C1 g.\n10. The toxicity from previous treatment has recovered to grade 1 (except for toxicity such as alopecia that the investigator determines does not pose a safety risk);\n11. Females and males of childbearing age must agree to take effective contraceptive measures during the study and within 3 months after the last dose of HB0025 after signing the informed consent form. Female subjects of childbearing age must have a negative pregnancy test result during the screening period.\n\nExclusion Criteria:\n\n1. Brain metastasis with central nervous system symptoms; for subjects with asymptomatic brain metastasis: after receiving relevant treatment, imaging and neurological examinations are in a stable state for more than 4 weeks. If there is no imaging evaluation, the neurological examination is in a stable state for more than 4 weeks under glucocorticoid treatment, and the treatment dose for at least 2 weeks is ≤10mg\u002Fday of prednisone or other hormones of the same dose, they can be included in the group;\n2. Active autoimmune diseases or a history of autoimmune diseases requiring systemic treatment within 2 years before screening, including hypothyroidism, Graves' ophthalmo-pathy, Hashimoto's thyroiditis or type 1 diabetes, but childhood asthma or allergic asthma that did not occur within 2 years before screening can be excluded;\n3. Patients who received \\>10 mg\u002Fday of prednisone or equivalent dose of systemic glucocorticoids or other immunosuppressants within 2 weeks before screening, or who received topical, intraocular, intraarticular, intranasal or inhaled hormones for prevention (such as contrast agent allergy) or treatment of non-autoimmune diseases (such as delayed hypersensitivity reactions caused by contact allergens) were allowed to be included in the group;\n4. Any of the following infections:\n\n   4.1 Active infection within 2 weeks prior to screening, requiring antibiotic treatment for \\>7 days; 4.2 Active pulmonary tuberculosis (based on history); 4.3 HIV positive; 4.4 Active hepatitis B or hepatitis C. Asymptomatic hepatitis B virus carriers (HBV DNA titer below the detection limit) or clinically cured hepatitis C (HCV RNA test negative) are allowed to enroll;\n5. Patients who have received immune checkpoint inhibitors (ICI) combined with anti-vascular therapy, such as anti-PD-(L)-1 antibody combined with anti-VEGF, VEGFR antibody, or TKI drugs with anti-vascular effects such as anlotinib;\n6. Patients with a history of severe allergies, previous grade 3-4 immune-related adverse events (irAEs) or treatment discontinuation (except for grade 3 endocrine abnormalities that can be controlled by hormone replacement therapy); patients with grade 3-4 allergic reactions when receiving other monoclonal antibody treatments, or patients with known allergies to protein drugs or recombinant proteins, HB0025 drug components, and chemotherapy drug components;\n7. Uncontrolled arterial hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment;\n8. Suffering from the following serious comorbidities:\n\n   8.1 Subjects with a history of arterial thrombosis or deep vein thrombosis within 6 months before screening, or subjects with evidence or history of bleeding tendency within 2 months before enrollment, regardless of severity (For the EC cohort: the decision on whether to enroll subjects with evidence or history of bleeding tendency within 2 months before enrollment was made by the investigator and the sponsor); 8.2 Previous or current bleeding or coagulation disorders; 8.3 Past history of myocarditis, cardiomyopathy, or malignant arrhythmias. Clinically significant (e.g., active) cardiovascular and cerebrovascular diseases within 6 months prior to screening, including but not limited to unstable angina requiring hospitalization, myocardial infarction, New York Heart Association-classified congestive heart failure ≥ II, severe arrhythmias that cannot be controlled by drugs, transient ischemic attack (TIA), cerebrovascular accident (CVA) or vascular disease (e.g., aortic aneurysm with risk of rupture), or other cardiac damage that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia), etc.; 8.4 Gastrointestinal disorders or conditions that may cause gastrointestinal bleeding or perforation (history of intestinal obstruction, acute Crohn's disease, ulcerative colitis, esophageal varices, unhealed ulcers, unhealed wounds, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to screening). Subjects with chronic Crohn's disease and ulcerative colitis (except those with total colon and rectal resection), even in the inactive stage, should be excluded; 8.5 Those who have had digestive tract perforation or fistula, urogenital system fistula, and have not recovered after surgical treatment; 8.6 Current clinically significant hydronephrosis that has not been relieved by nephrostomy or ureteral stenting; 8.7 Patients with third space effusion (such as pleural effusion, pericardial effusion or ascites) that is currently clinically poorly controlled and requires repeated puncture drainage or other local treatment; 8.8 Imaging (CT or MRI) shows that the tumor has invaded or surrounded important blood vessels (lung cancer cohort only) or the investigators judge that the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 8.9 Acute exacerbation of COPD within 1 month before first dose;\n9. Patients who have used or are currently taking anticoagulants such as warfarin, heparin (except for tube sealing and deep vein catheterization), dabigatran etexilate, rivaroxaban, etc. within 7 days before the first study treatment; or patients who have received aspirin, clopidogrel, dipyridamole, cilostazol, or other drugs known to inhibit platelet aggregation;\n10. Received major surgical treatment, open biopsy or significant trauma within 4 weeks before drug administration; or required major elective surgical treatment during the study period. Received local invasive procedures (such as needles) within 1 week before drug administration. Core biopsy), except for placement of a vascular access device;\n11. Those with past and\u002For current interstitial lung disease, pneumoconiosis, drug-related pneumonia, severe lung function impairment, etc. that may interfere with the detection and treatment of suspected drug-related pulmonary toxicity;\n12. Pregnant or breastfeeding women;\n13. History of allogeneic organ transplantation or hematopoietic stem cell transplantation;\n14. Second tumor within 5 years before screening, excluding cured cervical cancer in situ, localized skin squamous cell carcinoma, basal cell carcinoma, breast ductal carcinoma in situ or T1 urothelial carcinoma;\n15. Received live virus vaccine within 30 days before screening;\n16. During the screening period, patients with advanced Nonsq-NSCLC who are intolerant to the chemotherapy regimen of pemetrexed combined with carboplatin;\n17. During the screening period, patients with advanced sq-NSCLC or EC who are intolerant to paclitaxel combined with carboplatin chemotherapy;\n18. Subjects who are assessed by the investigator to be unsuitable for participating in the trial due to other reasons.","ALL","75 Years",{"count":165,"type":20},282,[23,102],"This study is a multicenter, two-tumor, multi-cohort, dose-escalation and dose-expansion Phase Ib\u002FII clinical trial of HB0025 combined with chemotherapy, consists of two phases: the dose escalation phase (Ib) and the dose expansion phase (II).\n\n1. The dose escalation phase (Phase Ⅰb) The primary purpose is to determine the Maximum Tolerated Dose(MTD) and\u002For dose limiting toxicity (DLT) of HB0025 combined with chemotherapy. The dose escalation is carried out using the \"3+3 dose escalation\" principle. In the initial stage of the dose escalation process, the chemotherapy dose remains unchanged to explore the safety and tolerability of the currently confirmed safe doses of HB0025 as monotherapy at 10mg\u002Fkg, and 20mg\u002Fkg, combined with chemotherapy(Pemetrexed 500 mg\u002Fm² iv d1+Carboplatin AUC 5 iv d1) in the treatment of advanced non-squamous non-samll cell lung cancer(Non-sq-NSCLC), and combined with chemotherapy( Paclitaxel 175 mg\u002Fm² iv d1+ Carboplatin AUC 5 iv d1 ) in advance Endometrial carcinoma(EC).\n\n   After completing the first cycle of treatment (DLT evaluation period), if the investigator determines that the subject may benefit from the combined treatment, the subject will continue the treatment cycles (2nd to 4th\u002F5th\u002F6th cycle of HB0025 combined with chemotherapy); if there is no disease progression and no intolerable toxicity, the subject can continue to receive the maintenance treatment with HB0025 + pemetrexed (for non-sq NSCLC) or HB0025 alone (for EC, sq NSCLC), until when intolerable toxicity occurs, disease progression, the subject is lost to follow-up or died, the subject withdraws informed consent, the subject receives other anti-tumor treatment or the study is terminated early, whichever occurs first.\n2. Dose expansion phase (Phase II) Based on 1-2 recommended Phase II doses selected by the sponsor and the investigator during the dose escalation process, a multicenter, single-arm study will be conducted to evaluate the efficacy and safety of different doses of HB0025 combined with chemotherapy. Each dosing regimen cohort will be expanded by 40 subjects. If a dosing regimen is not safe or effective, the enrollment of the dosing regimen cohort may be stopped, and the subject quota may be allocated to other dosing regimen cohorts (which may exceed 40 subjects). The dose expansion phase initially plans to expand the following cohorts to further observe the safety of HB0025 combined with chemotherapy and the preliminary efficacy of HB0025 combined with chemotherapy in advanced NSCLC and EC.\n\nAfter receiving 4-6 cycles of HB0025 combined with chemotherapy, the subjects will enter HB0025 + pemetrexed (for non-sq-NSCLC) or HB0025 alone (for EC, sq-NSCLC) maintenance treatment until when intolerable toxicity, disease progression or death occurs, withdraw informed consent, or receives other anti-tumor treatment or study ends early, early, whichever occurs first.",[169,28],"Advanced NSCLC",[171,27,172],"NSCLC","Clinical Trial","2025-01-22",{"date":175,"type":47},"2025-01-23",{"date":177,"type":47},"2024-01-31",{"date":179,"type":20},"2026-02-28",{"name":181,"class":54},"Huabo Biopharm Co., Ltd.",14,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":163,"enrollmentInfo":190,"targetDuration":4,"studyType":21,"phases":192,"briefSummary":193,"conditions":194,"keywords":195,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":207},"100560967","phase-3-study-of-fruquintinib-plus-sintilimab-for-treatment-of-advanced-endometrial-cancer-100560967","NCT06584032","Study of Fruquintinib Plus Sintilimab for Treatment of Advanced Endometrial Cancer","A Randomized,Open-label,Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of Fruquintinib Plus Sintilimab Versus Chemotherapy of the Treating Physician's Choice as Second-line Treatment for Advanced Endometrial Cancer","Inclusion Criteria:\n\n1. Have fully understood and voluntarily signed the informed consent form\n2. Age 18 to 75 years (inclusive) ; Body mass index (BMI) ≥ 18.5kg\u002Fm\\^2;\n3. Histologically or cytologically confirmed advanced or recurrent endometrial cancer with measurable lesions\n4. Patients who previously failed first-line systemic platinum-based therapy\n5. ECOG PS (Eastern Cooperative Oncology Group performance status score) 0 or 1;\n6. Need to provide tumor samples for central lab testing of biomarkers such as MSI(microsatellite instability) status;\n7. Non-MSI-H(non-microsatellite instability-high) by central lab or previous test result indicating pMMR(proficient mismatch repair);\n8. Adequate function of the major organs;\n9. Expected survival ≥ 12 weeks;\n10. Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization.\n\nExclusion Criteria:\n\n1. Endometrial carcinosarcoma or sarcoma;\n2. Known MMR(mismatch repair)\u002FMSI status with dMMR(deficient mismatch repair) or MSI-H(microsatellite instability-high);\n3. Toxicities related to prior anticancer therapy did not recover to ≤CTCAE Grade 1, except alopecia and oxaliplatin-induced peripheral neurotoxicity ≤CTCAE Grade 2;\n4. Received systemic anti-tumor therapy approved within 4 weeks before randomization;\n5. Other malignancies within the past 5 years;\n6. Previous or screening central nervous system (CNS) metastases;\n7. Radical radiotherapy within 4 weeks before randomization\n8. Previously received any anti-programmed cell death receptor-1 (PD-1) antibody, anti-PD-L1(programmed death ligand-1) antibody, anti-PD-L2(programmed death ligand-2) antibody, or anti cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T cell costimulation or checkpoint pathways (eg, OX40, CD137, etc) or small molecule vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors;\n9. Symptomatic or treatment-requiring thyroid dysfunction at screening;\n10. Use of immunosuppressive agents within 4 weeks before randomization\n11. Presence of any active autoimmune disease requiring systemic treatment or history of autoimmune disease within the past 2 years;\n12. Systemic immunostimulants within 4 weeks before randomization;\n13. Administration of any live or live-attenuated vaccine within 4 weeks before randomization or planned during the study;\n14. Major surgical procedures within 4 weeks before randomization;\n15. Uncontrolled malignant pleural effusion, ascites or pericardial effusion;\n16. Patients with current hypertension uncontrolled by medication;\n17. Patients with any current disease or condition affecting drug absorption, or patients unable to take oral medications;\n18. Receiving strong inducers of cytochrome P450 3A4 enzyme;\n19. Patients with gastrointestinal diseases or unresected tumors with active bleeding, or other conditions that may cause gastrointestinal bleeding and perforation as judged by the investigator; or with gastrointestinal perforation or gastrointestinal fistula, which is not recovered after surgical treatment;\n20. Active bleeding within 3 weeks before randomization, or melena, or bleeding from a tumor within 2 weeks before the first dose ;\n21. Tumor invading major vascular structures and is judged by the investigator to be at greater risk of massive haemorrhage;\n22. Patients who had arterial thrombosis or deep venous thrombosis within 6 months before randomization; or patients who had stroke events and\u002For transient ischemic attack within 12 months; patients who had thrombosis caused by implantable intravenous infusion pump or catheter, except patients who had stable thrombosis after conventional anticoagulant therapy;\n23. Clinically significant cardiovascular disease;\n24. Clinically significant electrolyte abnormalities as judged by the investigator;\n25. Active infection or fever of unknown origin before randomization;\n26. Patients with active pulmonary tuberculosis (TB) receiving anti-tuberculosis treatment or anti-tuberculosis treatment within 1 year before randomization;\n27. Patients with previous and current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severely impaired pulmonary function, which may interfere with the detection and management of suspected drug-related pulmonary toxicity; previous or current (non-infectious) pulmonary inflammation requiring steroid hormone therapy;\n28. Positive human immunodeficiency virus (HIV) antibody screening;\n29. Known history of clinically significant liver disease\n30. Known hypersensitivity to any of the study drugs or any of their excipients, or previous history of serious hypersensitivity to any other monoclonal antibody;\n31. Patients who have received other clinical drugs that have not been approved or marketed within 4 weeks before randomization;\n32. Women who are pregnant (positive pregnancy test before medication) or breastfeeding;\n33. Patients who have received tissue\u002Forgan transplantation;\n34. Patients with known psychiatric disorders or substance abuse disorders that could affect study compliance;\n35. Patients who, in the opinion of the investigator, have other reasons that would make them inappropriate for this clinical study.",{"count":191,"type":20},412,[127],"The goal of this study is to evaluate whether fruquintinib(HMPL-013) plus sintilimab(IBI308) is safe and effective in the treatment of advanced endometrial cancer(EMC).",[28],[196,197,106],"fruquintinib","sintilimab","2025-01-05",{"date":200,"type":47},"2025-01-07",{"date":202,"type":47},"2024-12-12",{"date":204,"type":20},"2029-06-09",{"name":206,"class":54},"Hutchmed",17]