[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-malignant-neoplasm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-malignant-neoplasm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,99,123,161,185,207],{"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":25,"conditions":26,"keywords":57,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":98},"100407463","phase-1-the-evaluation-of-pc14586-in-patients-with-advanced-solid-tumors-harboring-a-tp53-y220c-mutation-pynnacle-100407463",false,"NCT04585750","The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","A Phase 1\u002F2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)","Inclusion Criteria:\n\n* At least 18 years of age or 12 to 17 years of age after Safety Review Committee approval.\n* Locally advanced or metastatic solid malignancy with a TP53 Y220C mutation\n* Eastern Cooperative Oncology Group (ECOG) status of 0 or 1\n* Previously treated with one or more lines of anticancer therapy and progressive disease\n* Adequate organ function\n* Measurable disease per RECIST v1.1 (Phase 2)\n\nAdditional Criteria for Inclusion in Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Anti-PD-1\u002FPD-L1 naive or must have progressed on treatment\n* Measurable disease\n\nExclusion Criteria:\n\n* Anti-cancer therapy within 21 days (or 5 half-lives) of receiving the study drug\n* Radiotherapy within 14 days of receiving the study drug\n* Primary CNS tumor\n* History of leptomeningeal disease or spinal cord compression\n* Brain metastases, unless neurologically stable and do not require steroids to treat associated neurological symptoms\n* Stroke or transient ischemic attack within 6 months prior to screening\n* Heart conditions such as unstable angina within 6 months prior to screening, uncontrolled hypertension, a heart attack within 6 months prior to screening, congestive heart failure, prolongation of QT interval, or other rhythm abnormalities\n* Strong CYP3A4 inducers and strong CYP2C9 inhibitors\u002Finducers within 14 days of first dose of rezatapopt\n* History of gastrointestinal (GI) disease that may interfere with absorption of study drug or patients unable to take oral medication\n* History of prior organ transplant\n* Known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer\n* Known, active uncontrolled Hepatitis B, Hepatitis C, or human immunodeficiency virus infection\n\nAdditional Criteria for Exclusion from Phase 2 (rezatapopt monotherapy)\n\n* Known KRAS mutation, defined as a single nucleotide variant (SNV) (Phase 2)\n\nAdditional Criteria for Exclusion from Phase 1b (rezatapopt) + pembrolizumab combination)\n\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor and discontinued from that treatment due to a Grade 3 or higher immune-related AE (irAE)\n* Received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention\n* Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy within 7 days prior to the first dose of study drug\n* Hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients\n* Active autoimmune disease that has required systemic treatment in past 2 years\n* History of radiation pneumonitis\n* History of (non-infectious) or active pneumonitis \u002F interstitial lung disease that required steroids\n* Active infection requiring systemic therapy\n* Known history of HIV infection\n* Has previously received rezatapopt","ALL","12 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56],"Advanced Solid Tumor","Advanced Malignant Neoplasm","Metastatic Cancer","Metastatic Solid Tumor","Lung Cancer","Ovarian Cancer","Endometrial Cancer","Prostate Cancer","Colorectal Cancer","Breast Cancer","Other Cancer","Locally Advanced","Head and Neck Cancer","Gall Bladder Cancer","Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Small Cell Lung Carcinoma","NSCLC","NSCLC (Non-small Cell Lung Cancer)","SCLC","Non-Small Cell Lung Carcinoma","Triple Negative Breast Cancer","TNBC","HER2+ Breast Cancer","Non-Small Cell Lung Cancer","ER\u002FPR Positive Breast Cancer","HER2- Breast Cancer","HER2-positive Breast Cancer","HER2-negative Breast Cancer","ER\u002FPR(+), Her2(-) Breast Cancer",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85],"PC14586","p53","Y220C","Phase 1","Phase 1\u002F2","PMV","PMV Pharma","p53 mutation","TP53","TP53 mutation","p53 mutant","p53 reactivator","pembrolizumab","Keytruda","combination","PD-1","PD-L1","anti-PD-1","Merck","MSD","IgG4","mAb","Phase 1b","NGS","Next Generation Sequencing","precision","Phase 2","Rezatapopt","RECRUITING","2026-06-24",{"date":89,"type":90},"2026-06-26","ACTUAL",{"date":92,"type":90},"2020-10-29",{"date":94,"type":20},"2027-12-31",{"name":96,"class":97},"PMV Pharmaceuticals, Inc","INDUSTRY",77,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":105,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":106,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":121,"locationsCount":4},"100583143","expanded-access-protocol-for-the-use-of-sl-28-in-the-treatment-of-advanced-solid-tumors-100583143","NCT06872489","Expanded Access Protocol for the Use of SL-28 in the Treatment of Advanced Solid Tumors","Inclusion Criteria:\n\n* Subjects with locally advanced or metastatic solid tumor confirmed by histopathology;\n* Having at least one evaluable or measurable lesion according to the solid tumor response Evaluation Criteria (RECIST 1.1);\n* For patients with relapsed\u002Frefractory neuroblastoma with original diagnosis based on tumor histopathology, Karnofsky or Lansky performance status of ≥ 50%;\n* ECOG Performance Status from 0 or 3;\n* The expected survival time is more than 12 weeks;\n* 2 to 65+ old, gender is not limited;\n* The subjects gave informed consent to the study before participating in, and voluntarily signed informed consent;\n* Be able to comply with trial and follow-up procedures;\n* Adequate bone marrow and organ function;\n* Patients who have progressed, recurrent or refractory disease after first-line treatment (failure to obtain complete or partial remission after recent treatment);\n* Fertile women must agree to abstain from sex (abstaining from heterosexual intercourse)or use a highly effective method of contraception for at least one week from the time they sign an informed consent form until the last dose of the study drug.\n* The blood HCG test must be negative within 7 days before the start of the study treatment, and must be non-lactating;\n* For male patients whose partner is a woman of reproductive age, they must agree to abstain from sex for at least one week from signing the informed consent until the last dose of the study drug, or to use a highly effective method of contraception.\n* Immunotherapy: At least 42 days after completing any type of immunotherapy, including immune checkpoint;\n* Radiation therapy: 60 days should have elapsed in the case of completing radiation.\n* Cytokine therapy (e.g. G-CSF, GM-CSF, IL-6, IL-2): must be discontinued a minimum of 7 days prior to SL-28 therapy.\n\nExclusion Criteria:\n\n* Untreated or active primary central nervous system (CNS) tumor or metastasis;\n* Patients diagnosed of having primary and secondary immunodeficiencies;\n* Patients with disease of any major organ system that would compromise their ability to withstand therapy.\n* Arterial\u002Fvenous thrombosis events that occurred in the 12 months before enrollment, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;\n* Known allergy to any of the agents or their ingredients used in this study;\n* Patients who are on hemodialysis;\n* Pregnant or breast-feeding women; fertility patients who are unwilling or unable to take effective contraceptive measures;\n* Patients with untreated positive blood cultures or progressive infections.","2 Years","EXPANDED_ACCESS","This is an Expanded Access Program (EAP) that will give the participants access to the drug SL-28 before it is approved by the FDA. Participants in this study will have Advanced Solid Tumors who failed to respond to standard therapy (chemotherapy, immunotherapy) or developed progressive disease at any phase of standard therapy.\n\nResearchers think the SL-28 will be effective because SL-28 has a direct activity against different types of tumors.\n\nSL-28 is a cell-based therapy, based on leukocytes isolated from healthy donors and are activated through the proprietary process. After quality assessment (sterility, viable cell count, purity, and absence of infectious diseases), they are stored at -80°C until use. Upon need, the SL-28 is thawed, followed by checking their viability, count, and sterility. Adult and older adult patients aged 18 to 65+ who meet the eligibility criteria will be included in the study. Patients receive SL-28 IV once daily on days 1-5 and 8-12. Based on the patient's response, the need for additional injections will be evaluated. If improvements in the patient's condition are confirmed by MRI, further injections can continue on a rate 5 days a week.",[109,110,111,28,112,113,114,115,39,116],"Neuroblastoma in Children","Neuroblastoma, Recurrent, Refractory","Advanced Cancer","Prostate Cancer Patients With Bone Metastasis","Lung Cancer Non-Small Cell Cancer (NSCLC)","Lung Cancer - Non Small Cell","Gastrointestinal Cancers","Pancreatic Cancer","AVAILABLE","2025-07-17",{"date":120,"type":90},"2025-07-23",{"name":122,"class":97},"Second Life Therapeutics",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":21,"phases":133,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100401132","phase-1-a-trial-of-amxi-5001-for-treatment-in-patients-with-advanced-malignancies-100401132","NCT04503265","A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies","A Phase I\u002FII, Open Label, Multi-center, Non-randomized Dose Escalation and Dose Expansion Study of AMXI-5001 in Patients With Advanced Malignancies","Inclusion Criteria (Key Factors):\n\n1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following:\n\n   1. Patient is intolerant of existing therapy(ies) known to provide clinical benefit for their condition\n   2. Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit\n   3. Malignancy has progressed after standard therapy\n2. Has evaluable or measurable tumor(s) in dose escalation by standard radiological and\u002For laboratory assessments as applicable to their malignancy.\n3. Eastern Co-operative Oncology Group (ECOG) PS 0-1\n4. Participant must be 18 years of age or older\n5. Able to understand and sign consent\n\nExclusion Criteria (Key Factors):\n\n1. Receiving cancer treatment at the time of enrollment\n2. Any clinically significant disease or condition affecting a major organ system\n3. Significant cardiovascular disease or electrocardiogram (ECG) abnormalities\n4. Use of a strong inhibitor or inducer of CYP3A4 within 7 days prior to start of study therapy and throughout the study (e.g., some antibiotics, antifungals, anticonvulsants, grapefruit)\n5. Has had a previous (within 2 years) or has a current malignancy other than the target cancer","18 Years",{"count":132,"type":20},122,[23,24],"ATLAS-101 is a Phase I\u002FII clinical trial of AMXI-5001 in adult participants with advanced malignancies who have previously failed other therapies. The study has two phases. The purpose of Phase I (Dose Escalation) is to confirm the appropriate treatment dose and Phase II (Dose Expansion) is to characterize the safety and efficacy of AMXI-5001.",[28,36,32,136,34,116],"Homologous Recombination Deficiency",[138,139,140,141,142,143,144,145,146,147,148,149,150],"Breast","Ovarian","Prostate","Pancreatic","Refractory","Cancer","Malignancy","BRCA","HRD","AMXI-5001","Progression","PARP Inhibitor","Microtubule inhibitor","2025-04-29",{"date":153,"type":90},"2025-05-01",{"date":155,"type":90},"2020-08-12",{"date":157,"type":20},"2026-10",{"name":159,"class":97},"AtlasMedx, Incorporated",4,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":168,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":184},"100560766","phase-1-a-clinical-trial-to-evaluate-effect-of-iap0971-in-patients-with-advanced-malignant-tumors-100560766","NCT06581419","A Clinical Trial to Evaluate Effect of IAP0971 in Patients With Advanced Malignant Tumors","A Phase I\u002FII Clinical Study Evaluating Safety, Tolerability, and Efficacy of IAP0971 in Advanced Tumors","Inclusion Criteria:\n\n1. Age of 18-75 years old (including cut-off value), regardless of gender.\n2. Phase I only: patients with histologically confirmed advanced or metastatic malignant solid tumors who have failed to respond to standard treatment, who have no standard treatment options, who are not currently applicable to standard treatment, or who have been assessed by the investigator to benefit from this treatment.\n3. Phase II only: patients with histologically confirmed locally advanced (stage IIIB or IIIC) or metastatic (stage IV) non-small cell lung cancer (NSCLC) that is not amenable to complete surgical resection and definitive concurrent chemoradiotherapy. Note: For patients with locally advanced stage (stage IIIB\u002FIIIC) who cannot accept radical concurrent\u002Fsequential chemoradiotherapy, they need to be evaluated by relevant professional physicians and confirmed by written records.\n4. Phase II only: no prior systemic antitumor therapy for locally advanced or metastatic NSCLC (except for patients who received adjuvant\u002Fneoadjuvant chemotherapy or definitive concurrent or sequential chemoradiotherapy for locally advanced disease and disease progression ≥6 months after the last treatment).\n5. Phase II only: PD-L1 positive (TPS≥50%) as determined by IHC, and patients were negative for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) by immunohistochemistry.\n6. have at least one measurable lesion according to RECIST 1.1 criteria (tumor lesion located in the previous radiotherapy area or other locoregional treatment site, generally not considered a measurable lesion unless the lesion has clearly progressed or persists beyond three months of radiotherapy).\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n8. predicted survival time ≥3 months.\n9. with adequate organ function:\n\n   ① Blood system (no blood transfusion or hematopoietic stimulation therapy within 14 days) : absolute neutrophil count (ANC) ≥1.5×109\u002FL, platelet count (PLT) ≥100×109\u002FL, hemoglobin (HGB) ≥90 g\u002FL; ② Liver function: total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN), except Gilbert's syndrome Out of; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 times ULN, and patients with liver metastasis or liver cancer need AST and ALT≤5.0 times ULN and total bilirubin ≤3.0 times ULN;\n\n   ② Renal function: serum creatinine (Cr) ≤1.5 times ULN; If creatinine \\> 1.5 times ULN, creatinine clearance (Ccr) ≥50 mL\u002Fmin (calculated by Cockcroft-Gault formula) was required.\n\n   ③ Coagulation function: prothrombin international normalized ratio (INR) ≤1.5 times ULN, activated partial thromboplastin time (APTT) ≤1.5 times ULN, patients with liver metastasis or liver cancer need INR and APTT≤2.5 times ULN.\n10. Eligible patients (men and women) of childbearing potential must consent to use a reliable method of contraception (hormonal or barrier methods or abstinence) with their partner during the trial and for at least 6 months after the last dose; Female patients of reproductive age had to have a negative blood pregnancy test within 7 days before the first use of the study drug.\n11. Subjects must give informed consent for this study and voluntarily provide written informed consent before the trial.\n\nExclusion Criteria:\n\n1. Phase II only: small cell lung cancer or sarcomatoid lesion confirmed by histopathology.\n2. Phase II only: previous immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 \u002FPD-L1 antibody, anti-CTLA-4 antibody, etc.), immune checkpoint agonists (e.g. ICOS, CD40, CD137, GITR, OX40 antibody, etc.), immune cell therapy, and any treatment targeting the mechanism of tumor immune action.\n3. Phase I only: patients received anti-tumor therapy such as systemic chemotherapy, radiotherapy, biological therapy, endocrine therapy, or immunotherapy within 4 weeks before the first dose of study drug; The following drugs were excluded according to the following criteria:\n\n   ① Treatment with a small-molecule tyrosine kinase inhibitor within 2 weeks before the first dose;\n\n   ② Palliative local treatment for non-target lesions within 2 weeks before the first dose; Patients received non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, not including IL-11) within 2 weeks before the first dose;\n\n   ③ received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 2 weeks before the first dose.\n4. received other investigational drugs or treatments within 4 weeks before the study drug.\n5. received systemic glucocorticoids (prednisone \\> 10 mg\u002F day or equivalent) or other immunosuppressive agents within 14 days before the first dose of study drug; The use of topical, ocular, intra-articular, nasal, and inhaled glucocorticoids was excluded. Short-term prophylaxis with glucocorticoids (e.g., to prevent contrast allergy).\n6. the adverse effects of previous antineoplastic therapy have not recovered to CTCAE 5.0 grade ≤1 or the relevant requirements of the inclusion criteria (except for toxicities without safety risks judged by the investigators, such as alopecia, grade 2 peripheral neurotoxicity, and hypothyroidism stable with hormone replacement therapy).\n7. major surgical procedures (excluding needle biopsies) within 4 weeks before the first dose of study drug, major trauma, or the need for elective surgery during the trial.\n8. prior allogeneic hematopoietic stem-cell transplantation or organ transplantation.\n9. clinically symptomatic parenchymal or meningeal metastases.\n10. have active infection and currently require intravenous anti-infective therapy.\n11. have a history of immunodeficiency, including testing positive for human immunodeficiency virus (HIV) antibodies.\n12. active hepatitis B (HBsAg positive and HBV-DNA positive or greater than the upper limit of normal), active hepatitis C (hepatitis C virus antibody positive and HCV RNA positive or greater than the upper limit of normal).\n13. received any live vaccine within 4 weeks before the first dose of study drug.\n14. known hypersensitivity to any antibody-based drug (NCI CTCAE grade 5.0 ≥3) or to the study drug, active ingredient, or inactive excipients of a PD-1\u002FPD-L1 inhibitor.\n15. with severe and uncontrollable lung diseases (severe infectious pneumonia, interstitial lung disease, etc.); Or other moderate-to-severe lung diseases that severely affect respiratory function that may interfere with the detection or management of drug-related pulmonary toxicity.\n16. have a history of severe cardiovascular and cerebrovascular disease, including but not limited to:\n\n    ① Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmia requiring clinical intervention, II-III degree atrioventricular block, etc.\n\n    ② Mean QT interval corrected with Fridericia's method (QTcF) \\> 470 ms;\n\n    ③ Acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 or above cardiovascular and cerebrovascular events occurred within 6 months before the first dose; ④ patients with New York Heart Association (NYHA) functional class ≥II heart failure or left ventricular ejection fraction (LVEF) \\\u003C 50% or structural heart disease with high risk as judged by other investigators; And 5) clinically uncontrolled hypertension.\n17. have an active or previous autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.) with the possibility of recurrence, except clinically stable autoimmune thyroid disease, type I diabetes mellitus, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years) that does not require systemic treatment.\"\n18. had other malignancies within 5 years before study administration, except for malignancies that could be expected to be cured with treatment (including, but not limited to, adequately treated thyroid cancer, carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).\n19. have clinically uncontrollable effusion in the third space, which was judged by the investigator to be not suitable for enrollment.\n20. known alcohol or drug dependence.\n21. with mental disorders or poor adherence.\n22. pregnant or lactating women.\n23. The participant was deemed by the investigator to have a history of other serious systemic diseases or to be ineligible for the study for other reasons.","75 Years",{"count":170,"type":20},78,[23,24],"Phase I: To evaluate the safety, tolerance and effectiveness of IAP0971 for the treatment of advanced malignant tumors.\n\nPhase II: Evaluation of IAP0971 therapy driver negative and PD-L1 positive (TPS≥50%) The initial treatment is effective in subjects with advanced or metastatic non-small cell lung cancer.",[28,174],"Advanced or Metastatic Non-small Cell Lung Cancer","2025-01-13",{"date":177,"type":90},"2025-01-15",{"date":179,"type":90},"2024-12-31",{"date":181,"type":20},"2029-08-01",{"name":183,"class":97},"SUNHO（China）BioPharmaceutical CO., Ltd.",1,{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":4},"100546421","phase-1-a-study-to-evaluate-the-efficacy-and-safety-of-qlf31907-combination-therapy-in-patients-with-advanced-malignant-tumors-100546421","NCT06394713","A Study to Evaluate the Efficacy and Safety of QLF31907 Combination Therapy in Patients With Advanced Malignant Tumors","A Phase 1b\u002F2 Trial to Evaluate the Efficacy and Safety of QLF31907 (PD-L1\u002F4-1BB Bi-specific Antibody) Combination Therapy in Patients With Advanced Malignant Tumors","Inclusion Criteria:\n\n1. subjects voluntarily participated and signed a written informed consent form;\n2. age ≥18 years, male or female;\n3. ECOG PS 0-1;\n4. histopathologically diagnosed advanced malignant tumors;\n5. at least 1 measurable lesion according to RECIST v1.1 criteria or Lugano (2014) criteria;\n6. adequate organ function;\n\nExclusion Criteria:\n\n1. previous treatment with 4-1BB agonist or 4-1BB recombinant fusion protein;\n2. received anti-tumor therapy within 4 weeks prior to the first study treatment;\n3. history of autoimmune disease;\n4. history of other active malignancies within 3 years prior to the first treatment;\n5. history of serous cardiovascular events;",{"count":193,"type":20},60,[23,24],"This study is designed to evaluate the safety and efficacy of QLF31907 combination therapy in advanced malignant tumors.",[28],"NOT_YET_RECRUITING","2024-04-29",{"date":200,"type":90},"2024-05-01",{"date":202,"type":20},"2024-06-15",{"date":204,"type":20},"2026-12-15",{"name":206,"class":97},"Qilu Pharmaceutical Co., Ltd.",{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":130,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":21,"phases":216,"briefSummary":218,"conditions":219,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":184},"100514959","early-phase-1-clinical-application-of-lutetium-177lu-catalase-in-tumor-radionuclide-therapy-100514959","NCT05985278","Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy","Inclusion Criteria:\n\n1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;\n2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and\u002For cytology;\n3. Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;\n4. Expected survival of more than 3 months;\n5. According to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter ≥10 mm at baseline (in the case of lymph nodes, the short diameter ≥15 mm). This lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal).\n6. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC≥4.0×109L or neutrophil ≥1.5×109L, PLT≥100×109\u002FL, Hb≥90g\u002FL; PT or APTT≤1.5ULN; Liver and kidney function: T-Bil≤1.5×ULT(upper limit of normal),ALT\u002FAST≤2.5ULN or ≤5×ULT(subjects with liver metastasis), ALP≤2.5ULN(ALP≤ 4.5ULN if there is bone metastasis or liver metastasis); BUN≤1.5×ULT, SCr≤1.5×ULT;\n7. Women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives\u002Fpills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;\n8. Can understand and voluntarily sign informed consent, compliance is good\n\nThe Exclusion Criteria:\n\n1. Severe abnormal liver and kidney function;\n2. Pregnant, pregnant and lactating women;\n3. Can not lie flat for half an hour;\n4. Refuse to join the clinical investigator;\n5. Suffering from claustrophobia or other mental illness;\n6. Other conditions deemed unsuitable for participation in the trial by the investigator","70 Years",{"count":215,"type":20},10,[217],"EARLY_PHASE1","The purpose of this study is to evaluate the retention in tumour and distribution behavior of \\[Lu-177\\]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \\[Lu-177\\]-Catalase.",[28],"2023-08-02",{"date":222,"type":90},"2023-08-14",{"date":224,"type":90},"2023-07-06",{"date":226,"type":20},"2026-06-15",{"name":228,"class":229},"Peking University Cancer Hospital & Institute","OTHER"]