[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,45,73,95,117,145,166],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639383","phase-1-a-phase-i-trial-of-gw01-200-tablets-in-subjects-with-advanced-tumors-100639383",false,"NCT07629258","A Phase I Trial of GW01-200 Tablets in Subjects With Advanced Tumors","A First-in-Human Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GW01-200 Tablets in Subjects With Advanced Tumors","GW01-200-01","Inclusion Criteria:\n\n* Documented locally advanced or metastatic solid tumors or advanced hematological malignancies, with disease progression after standard treatment, or intolerant to standard treatment, or no standard treatment is available.\n* Have at least one measurable target lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Minimum life expectancy ≥ 3 months.\n* Adequate organ and marrow function.\n\nExclusion Criteria:\n\n* Participants with a known hypersensitivity to the investigational product(s) or any of the excipients of the product(s).\n* History of other primary malignancies, except for those who have been curatively treated and have no known active disease within 5 years prior to the first dose with a very low potential for recurrence, or adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or papillary thyroid cancer with no evidence of disease.\n* Presence of primary central nervous system (CNS) tumors or symptomatic brain metastases; prior or current leptomeningeal disease or spinal cord compression.\n* Radiographic evidence of tumor invasion into major blood vessels (tumor completely approaching, surrounding, or invading the lumen of major blood vessels such as the pulmonary artery or superior vena cava) or evidence of tumor thrombus.\n* Received systemic anti-tumor therapy within 28 days prior to the first dose, including chemotherapy, targeted therapy, anti-angiogenic drugs, biological therapy, immunotherapy, radiotherapy, etc., or received traditional Chinese medicine or herbal medicines with clear anti-tumor effects within 1 week prior to the first dose.\n* Treatment with medications that may affect the metabolism of the investigational drug within 14 days prior to the first dose, such as strong CYP3A inhibitors, strong CYP3A inducers, or P-gp inhibitors.\n* Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of the investigational drug.\n* Known to have active infection, including hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis.\n* Known history of infection with human immunodeficiency virus (HIV).\n* Active gastrointestinal disease or other condition that will interfere significantly with the swallowing, absorption, distribution, metabolism, or excretion of oral therapy.\n* For female subjects: currently pregnant or lactating.\n* Presence of clinically significant severe ophthalmic examination abnormalities at screening, such as retinitis pigmentosa, maculopathy, active ocular infection, etc., or known history of retinal or optic nerve disorders, such as retinitis pigmentosa, maculopathy, glaucoma, optic neuritis, etc.\n* Participants with a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or a history of melena or hematemesis within 2 months before dosing, or those who may experience visceral hemorrhage as determined by the investigator.\n* Clinically symptomatic moderate to severe ascites or pleural effusion, or presence of uncontrolled or moderate to severe pericardial effusion.","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","A phase 1, open-label, first-in-human study mainly aimed to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of GW01-200 tablets in participants with advanced tumors, including solid tumors and hematological malignancies.",[27],"Advanced Tumors",[29,30,31],"GW01-200","Phase I trial","Advanced tumors","NOT_YET_RECRUITING","2026-06-01",{"date":35,"type":36},"2026-06-05","ACTUAL",{"date":38,"type":21},"2026-06",{"date":40,"type":21},"2029-06",{"name":42,"class":43},"Groovy Medicine (Hangzhou) Ltd.","INDUSTRY",2,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100576718","phase-2-tarlatamab-in-advanced-delta-like-3-dll3-expressing-tumors-including-neuroendocrine-neoplasms-100576718","NCT06788938","Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms","Tarlatamab in Advanced DLL3-Expressing Tumors Including Neuroendocrine Neoplasms","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Participant has provided informed consent prior to initiation of any study specific activities\u002Fprocedures.\n2. Male or female ≥ 18 years of age and willing and able to provide informed consent.\n3. Histologically or cytologically confirmed malignancy other than de novo (i.e., non-transformed) SCLC or NEPC. Must be stage IV (metastatic); participants with stage III disease are eligible provided that they are not candidates for surgery and\u002For radiotherapy with curative intent. Acceptable tumor types include the following:\n\n   * Low and intermediate grade neuroendocrine carcinoma (including carcinoid and atypical carcinoid)\n   * Gastroenteropancreatic NEN\n   * Large cell neuroendocrine carcinoma\n   * SCLC transformed from previously-treated NSCLC\n   * Extrapulmonary small cell carcinoma, with the exception of NEPC\n   * Any other tumor type that meets staging and DLL3 positivity criteria\n4. Positive DLL3 expression by immunohistochemistry on tumor biopsy.\n\n   • Positive DLL3 expression, for purposes of this study, defined as at least 25% for participants enrolling into Stage 1 or 1% for participants enrolling into Stage 2.\n5. Participants must have progressed on or following at least one line of therapy, if a standard of care therapy exists for the tumor type.\n6. Measurable disease, as per RECIST 1.1\n7. ECOG performance status of 0-1.\n8. Adequate organ function as defined in Table 3 below. System Laboratory Value Hematological Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL Platelets ≥ 100 x 109\u002FL Hemoglobin ≥ 9 g\u002FdL Renal Estimated glomerular filtration rate (eGFR) based on Modification of Diet in Renal Disease (MDRD) ≥ 30 mL\u002Fmin\u002F1.73 m2 Hepatic Serum total bilirubin ≤ 1.5 x ULN, with the exception of participants with Gilbert's disease AST (SGOT) and ALT (SGPT) ≤ 3 x ULN≤ 5 x ULN for patients with liver metastasis or primary liver cancer Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT), and Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy, and then only as long as PT or PTT is within therapeutic range of intended use of anticoagulants\n\nExclusion Criteria:\n\nDisease Related\n\n1. Diagnosis of SCLC (with the exception of SCLC transformed from previously-treated NSCLC) or NEPC.\n2. Tumor specimen is not evaluable for DLL3 expression or tumor has DLL3 surface expression \\\u003C 1% by immunohistochemistry.\n3. Progressive or symptomatic brain metastases. Brain metastases that have been radiated, are asymptomatic, and on a stable or decreasing dose of steroids are allowed. Leptomeningeal disease is excluded.\n4. Evidence of interstitial lung disease or active, non-infectious pneumonitis. Exception: pneumonitis related to prior radiation therapy that is grade 1 and stable or improving without treatment.\n\n   Prior\u002FConcomitant Therapy\n5. Concurrent enrollment in another clinical study, unless enrolled only in the follow-up period or an observational study. Use of any investigational anticancer therapy must not have been received within 28 days prior to the first dose of study drugs.\n6. Any chemotherapy, antibody drug conjugate or immunotherapy for cancer treatment in the prior 21 days, or small molecular inhibitor in the prior 7 days.\n\n   • Stereotactic, palliative radiation for symptomatic bone metastases is acceptable without a washout.\n\n   • Stereotactic brain radiation for asymptomatic brain metastases is acceptable with a 7-day washout.\n7. Prior therapy with any selective inhibitor of the DLL3 pathway.\n8. Prior history of severe or life-threatening events from any immune-mediated therapy.\n9. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 7 days prior to enrollment. Low-dose corticosteroids (prednisone ≤ 10 mg per day or equivalent is permitted)\n10. Major surgical procedures within 28 days prior to first dose of study treatment.\n11. Treatment with live virus, including live-attenuated vaccination, within 14 days prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines within 3 days prior to first dose of study treatment.\n\n    Other Medical Conditions\n12. History of other malignancy within the past 2 years, with the following exceptions:\n\n    • Malignancy treated with curative intent before enrollment, with no known active disease and felt to be at low risk for recurrence by the treating physician, after discussion with the medical monitor.\n    * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    * Adequately treated cervical carcinoma in situ without evidence of disease.\n    * Adequately treated breast ductal carcinoma in situ without evidence of disease.\n    * Prostatic intraepithelial neoplasia without evidence of prostate cancer.\n    * Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.\n13. History of myocardial infarction and\u002For symptomatic congestive heart failure (New York Heart Association, class II) within 6 months prior to first dose of study treatment.\n14. History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months prior to first dose of study treatment.\n15. Human immunodeficiency virus (HIV) infection.\n\n    • Participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study per local or institutional guidelines\n16. Active hepatitis C infection.\n\n    • Defined as participants with detectable hepatitis C antibody \\[HCV Ab\\] and hepatitis C virus \\[HCV\\] RNA viral load above the limit of quantification\n\n    • Participants with presence of HCV antibody (HCV Ab positive) and HCV RNA viral load below the limit of quantification (HCV RNA negative) with or without prior treatment are allowed\n17. Active hepatitis B infection. • Defined as presence of hepatitis B surface antigen \\[HBsAg-positive\\] and hepatitis B virus \\[HBV\\] DNA viral load above the limit of quantification \\[HBV DNA positive\\] • Participants with resolved HBV infection defined as absence of HBV surface antigen (HBsAg-negative) and presence of HBV core antibody (anti-HBc positive) followed by an HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n\n    • Participants with chronic HBV infection inactive carriers state, defined as presence of HBV surface antigen (HBsAg-positive) and HBV DNA viral load below the limit of quantification (HBV DNA negative) are allowed, with a requirement for regular monitoring for reactivation for the duration of treatment on the study and assessing the need for HBV prophylaxis therapy per local or institutional guidelines.\n18. Participants with symptoms and\u002For clinical signs and\u002For radiographic signs that indicate an acute and\u002For uncontrolled active systemic infection within 7 days prior to the first dose of study treatment.\n\n    * Upon completion of antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint.\n    * Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment. Participants requiring oral antibiotics who have been afebrile \\> 24 hours, have no leukocytosis, nor clinical signs of infection are eligible. Screening for chronic infectious conditions is not required unless otherwise noted as exclusion criteria.\n\n    Other Exclusions\n19. Female participants of childbearing potential unwilling to use protocol specified method of contraception (see Section 5.7.2) during treatment and for an additional 60 days after the last dose of study treatment.\n20. Female participants who are breastfeeding or who plan to breastfeed while on study through 60 days after the last dose of study treatment.\n21. Female participants planning to become pregnant or donate eggs while on study through 60 days after the last dose of study treatment.\n22. Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test.\n23. Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 60 days after the last dose.\n24. Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 60 days after the last dose of study treatment.\n25. Male participants unwilling to abstain from donating sperm during treatment and for an additional 60 days after the last dose of study treatment.\n26. Participant has known sensitivity to any of the products or components to be administered during dosing.\n27. Participant likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant's and investigator's knowledge.\n28. History or evidence of any other clinically significant disorder, condition, or disease (with the exception of those outlined above) that, in the opinion of the investigator, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.\n\n    \\-",{"count":53,"type":21},29,[55],"PHASE2","This study is being done to learn more about the drug tarlatamab in people with your condition. The purpose of this study is to see the efficacy (how well something works) of study treatment (tarlatamab) and whether it causes any side effects. Tarlatamab is being developed as an anti-cancer drug for tumors and is FDA-approved for extensive-stage small cell lung cancer. Tarlatamab is investigational for the purpose of this study.",[58,27],"DLL3-expressing Tumors",[60],"tumor","RECRUITING","2026-05-14",{"date":64,"type":36},"2026-05-18",{"date":66,"type":36},"2025-03-21",{"date":68,"type":21},"2029-04-24",{"name":70,"class":71},"Jonsson Comprehensive Cancer Center","OTHER",5,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100534922","phase-1-a-study-of-cs23546-in-subjects-with-advanced-tumors-100534922","NCT06245122","A Study of CS23546 in Subjects With Advanced Tumors","A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of CS23546 in Subjects With Advanced Tumors","Key Inclusion Criteria:\n\n1. Male or female and ≥18 years of age on day of signing informed consent.\n2. Histologically or cytologically confirmed unresectable advanced recurrent\u002Frefractory solid tumor or lymphoma that is failure or or intolerant of all standard therapy or for which no standard therapy is available.\n3. Individuals are required to provide tumor tissue samples for prospective detection of Programmed cell death 1 ligand 1 (PD-L1) expression and\u002For Microsatellite instability (MSI) \u002F the DNA mismatch repair (MMR) status. Subjects who cannot be provided during the dose escalation phase will be evaluated by the researchers and sponsors before deciding whether to enroll.\n4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n5. Adequate organ function.\n6. Life expectancy ≥12 weeks.\n7. Dose expansion phase: Cohort 1, Subjects with urothelial carcinoma. Cohort 2, Subjects with Extranodal NK\u002FT-cell lymphoma (NKTCL). Cohort 3, Subjects with soft tissue sarcoma. Cohort 4, Subjects with PD-L1 expression positive and\u002For microsatellite-instability-high (MSI-H) \u002F mismatch-repair-deficient (dMMR) advanced solid tumors or lymphoma\n\nKey Exclusion Criteria:\n\n1. Received anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days before the first medication.\n2. History of ≥ Grade 3 immune related Adverse Events (irAEs) or termination of treatment due to irAEs during prior treatment with Programmed death 1 (PD-1) \u002FPD-L1 antibody.\n3. Active autoimmune diseases present during the screening period and systemic treatment was received within 2 years before the first medication. Individuals who only require hormone replacement therapy (such as thyroxine, insulin, or physiological corticosteroids used for adrenal or pituitary insufficiency) can be enrolled.\n4. Presence of central nervous system metastasis and\u002For meningeal metastasis.\n5. Dose expansion phase: Subjects with solid tumors or lymphoma who have previously received PD-L1 inhibitors and belong to primary resistance.",{"count":81,"type":21},156,[24],"The primary objectives of this study are to characterize the safety and tolerability of CS23546 and to evaluate the pharmacokinetic (PK) characteristics and recommended phase 2 dose (RP2D) of CS23546 in subjects with advanced tumors.",[27],"2026-04-03",{"date":87,"type":36},"2026-04-06",{"date":89,"type":36},"2024-03-27",{"date":91,"type":21},"2027-05-31",{"name":93,"class":43},"Chipscreen Biosciences, Ltd.",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100601445","phase-1-dose-escalation-and-dose-expansion-study-of-mdx2004-in-participants-with-advanced-tumors-100601445","NCT07110584","Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors","A Phase 1\u002F2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age.\n* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* All participants should have at least 1 measurable site of disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.\n* Adequate hematologic, hepatic and renal function.\n* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any clinically significant cardiac disease.\n* Unresolved toxicities from previous anticancer therapy.\n* Known untreated, active, or uncontrolled brain metastases.\n* Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.\n* Active medical condition requiring chronic systemic steroid use (\\>10 mg\u002Fday prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.\n* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.\n* Prior solid organ or hematologic transplant\n* Require supplemental oxygen for activities of daily living\n* Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.",{"count":103,"type":21},235,[24,55],"This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.",[27],"2026-03-04",{"date":109,"type":36},"2026-03-05",{"date":111,"type":36},"2025-10-01",{"date":113,"type":21},"2031-06-30",{"name":115,"class":43},"ModeX Therapeutics, An OPKO Health Company",6,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":130,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":94},"100608718","phase-1-a-clinical-trial-of-sibp-a10-injection-in-the-treatment-of-advanced-malignant-tumor-subjects-100608718","NCT07205198","A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.","A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects","Inclusion Criteria:\n\n* Voluntarily participate in this study and sign an informed consent form;\n* Age range of 18 to 75 years old (including boundary values), gender not limited;\n* The clinical diagnosis of enrolled subjects should meet the conditions specified in the protocol:\n* There must be at least one measurable lesion as the target lesion;\n* Backfilling queue during dose escalation stage, dose expansion stage, and indication expansion stage: able to provide tumor tissue samples that meet the requirements of the protocol or undergo tumor biopsy during screening, or provide testing reports issued by legitimate testing institutions that meet the requirements;\n* I have not received any medication targeting Siglec-15 in the past;\n* The Eastern Cooperative Oncology Group (ECOG) physical fitness score ranges from 0 to 1;\n* Expected survival period ≥ 3 months;\n* During the screening period, the main organ functions were basically normal;\n* During the screening period, women of childbearing age had negative blood pregnancy tests, and reproductive age subjects (including male subjects) had no pregnancy plans during the trial period and within 6 months after the last dose, and voluntarily took effective contraceptive measures.\n\nExclusion Criteria:\n\n* The subject has the following tumors:\n\n  * The subject has had other malignant tumors that have not healed within the past 5 years;\n  * Subjects with meningeal metastases;\n  * Subjects with active brain metastases;\n* For anti-tumor subjects with a history of past treatment or surgery that does not comply with the protocol, or who have received treatment that does not comply with the protocol during the planned trial period\n* Previous medical history or laboratory non-compliance with protocol requirements\n* According to the researchers' assessment, the screening period is accompanied by severe, progressive, or uncontrolled non-tumor diseases, and it has been determined by the researchers that participating in the study would increase the risk for the subjects.\n* According to the investigator's judgment, there are concomitant diseases (including but not limited to hypertension, diabetes, active infection, etc. that cannot be controlled by drugs) that seriously endanger the patient's safety or affect the patient's completion of the study\n* Researchers determine that there are uncontrollable ascites, pleural effusion, or pericardial effusion, or those who have undergone ≥ 2 serosal drainage within 2 weeks prior to the first administration;\n* Before starting treatment, the patient has not yet recovered to ≤ grade 1 from the toxic effects of previous treatments (including previous immunotherapy) and\u002For complications of previous surgical interventions.\n* Individuals with a history of severe allergies to protein products, CHO cell products, other recombinant human or humanized antibodies, or components of the investigational drug;\n* Pregnant and lactating women;\n* Researchers believe that subjects who are not suitable to participate in this clinical study due to other reasons.","75 Years",{"count":126,"type":21},160,[24],"To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).",[27],[131,132,133,134,135],"Advanced malignant tumor","SIBP-A10","safety","efficacy","pharmacokinetics","2026-01-06",{"date":138,"type":36},"2026-01-08",{"date":140,"type":36},"2025-10-31",{"date":142,"type":21},"2028-12-30",{"name":144,"class":43},"Shanghai Institute Of Biological Products",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":22,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":94},"100606709","phase-1-a-study-of-al58805-in-patients-with-advanced-tumors-100606709","NCT07179081","A Study of AL58805 in Patients With Advanced Tumors","Phase I Clinical Study on Dose-Escalation Tolerability and Pharmacokinetics of AL58805 in Patients With Advanced Tumors","Inclusion Criteria:\n\nSubjects must meet all the following criteria to be eligible:\n\n1. Patients with histologically or cytologically confirmed advanced tumors (including but not limited to lymphoma, colorectal cancer, breast cancer, pancreatic cancer, lung cancer, head and neck cancer, bladder cancer, cholangiocarcinoma) who lack effective standard treatment options or have failed conventional standard treatments (due to disease progression or intolerable toxicity).\n2. Previous treatment with cytotoxic chemotherapy, with at least 4 weeks between the end of chemotherapy and enrollment, and recovery from previous chemotherapy toxicities to ≤ Grade 1 (except alopecia).\n3. Must have measurable lesions according to RECIST 1.1 criteria.\n4. Major organ function: Absolute neutrophil count (ANC) ≥1.5 × 10\\^9\u002FL (1500\u002Fmm3), platelets ≥75 × 10\\^9\u002FL, hemoglobin ≥9g\u002FdL. Serum total bilirubin ≤2 × upper limit of normal (ULN). Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL\u002Fmin. For patients without liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Left ventricular ejection fraction (LVEF) ≥ lower limit of normal.\n5. Age ≥18 years; ECOG performance status (PS) 0 or 1.\n6. Expected survival time of at least 12 weeks.\n7. No malabsorption or other gastrointestinal diseases affecting drug absorption.\n8. For women of childbearing potential: Negative pregnancy test before treatment and use of medically approved contraception during treatment and for 3 months after treatment ends. Must be non-lactating.\n9. For male subjects: Surgical sterilization or use of medically approved contraception during treatment and for 3 months after treatment ends.\n\nAbility to understand and sign informed consent.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded:\n\n1. Known allergy to the investigational drug or drugs with similar chemical structures.\n2. Use of unapproved drugs or other investigational drugs within 30 days before enrollment.\n3. Status of the organ systems:\n\n   Current symptomatic brain metastases or leptomeningeal metastases, or central nervous system (CNS) metastases with uncontrolled symptoms within 8 weeks of first dose.\n\n   Uncontrolled hypertension requiring multiple medications (Grade 2 or higher). Acute myocardial infarction within 6 months. Current arrhythmias (e.g., long QT syndrome, Bazett's corrected QTc ≥480 ms). NYHA Class III or IV heart failure. Poorly controlled diabetes. Any unstable systemic disease (including active infection, angina, hepatic, renal, or metabolic diseases).\n\n   Presence of ascites or pleural effusion (CTCAE 5.0 ≥ Grade 2). Persistent diarrhea (average watery stools ≥1 per day). History of definite neurological or psychiatric disorders (e.g., epilepsy, dementia, mood disorders).\n4. The functional level of each organ： Urine protein ≥++ and 24-hour urine protein \\>1.0 g. Patients treated with anticoagulants or vitamin K antagonists, such as warfarin, heparin, or their analogs, should have an international normalized ratio (INR) of prothrombin time ≤1.5. In this case, low-dose warfarin (1mg, orally, once daily) or low-dose aspirin (daily dose not exceeding 100mg) can be used for prophylactic purposes. All other conditions are considered exclusion criteria.\n\n   Patients with active\u002Fvenous thrombosis events within 6 months, such as cerebrovascular accidents (including transient ischemic attacks), deep vein thrombosis and pulmonary embolism.\n5. Previous treatment with the investigational drug.\n6. Patients exhibiting hepatitis B surface antigen (HBsAg) positivity with HBV DNA concentrations ≥10⁴ copies\u002FmL (equivalent to 2000 IU\u002FmL) must initiate antiviral therapy prior to study consideration. Eligibility for enrollment is contingent upon achieving sustained HBV-DNA suppression below these threshold values. Antiviral therapy will be maintained throughout the study period with concurrent monitoring of hepatic function parameters and quantitative HBV DNA levels. The exclusion criteria further encompass individuals with detectable HCV antibodies or HCV RNA, HIV seropositivity, congenital\u002Facquired immunodeficiencies, or prior organ transplantation history.\n7. Concurrent other anti-tumor treatments. Other conditions deemed unsuitable by the investigator.",{"count":153,"type":21},40,[24],"This Phase I clinical trial is a dose-escalation, multicenter study in patients with advanced solid tumors. It includes tolerance studies of sequential multiple oral doses of AL58805 and pharmacokinetic studies of single and multiple doses, analyzing the tolerance range of multiple doses, observing the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) in solid tumor patients, and assessing the reversibility of toxicity and the relationship between toxicity and dose.",[27],"2025-09-15",{"date":159,"type":36},"2025-09-17",{"date":161,"type":36},"2020-12-20",{"date":163,"type":21},"2026-01-26",{"name":165,"class":43},"Advenchen Laboratories Nanjing Ltd.",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":173,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":176,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":44},"100540226","phase-2-individualized-neoantigen-therapy-with-unusual-radiotherapy-enhancement-inature-100540226","NCT06314087","Individualized Neoantigen Therapy with Unusual Radiotherapy Enhancement (iNATURE)","Individualized Tumor Neoantigen Peptide Vaccine in Combination with Unusual Immune Stimulating Radiotherapy in Refractory Solid Tumors (iNATURE) - a Phase II Randomized and Crossover Study","Inclusion Criteria:\n\n1. male or female\n2. age\\>18 years old\n3. with advanced or recurrent malignancies diagnosed by pathology and imaging, who have failed systemic standard therapy or disease progression prior to enrollment and have no effective first-line therapy (for effective therapy, refer to the latest version of the treatment guidelines published by the Chinese Society of Clinical Oncology)\n4. have at least one imaging measurable lesion\n5. with an expected survival of ≥ 3 months\n6. with an ECOG (Eastern Cooperative Oncology Group) score of 0-2\n7. have access to sufficient tumor DNA (circulating tumor DNA or tissue samples) for analysis, or have genomic\u002Fexonic\u002Ftranscriptional data from tumor and normal tissues and the data meet the analysis requirements, qualified for tumor neoantigen screening, or have prepared neoantigen peptides from a certified company (GMP)\n8. women of childbearing age should have negative pregnancy tests within 7 days prior to enrollment, and have no short-term plans to have children and are willing to take protective measures (contraception or other birth control methods) before and during the clinical trial\n9. compliant patients who is and able to follow the study protocol and the follow-up procedures\n\nExclusion Criteria:\n\n1. No neoantigens detected in the sequencing data.\n2. with a history of bone marrow or stem cell transplantation\n3. enrolled in other therapeutic clinical trials; clinical trials of Chinese medicine\n4. with active bacterial or fungal infections\n5. with active HIV (human immunodeficiency virus, human immunodeficiency virus), HCV (hepatitis C virus), HBV (hepatitis B virus), or the herpes virus (except for crusting for more than 4 weeks), or with respiratory viral infections (except for those who have been cured for more than 4 weeks)\n6. with asthma, autoimmune disease, immunodeficiency\n7. under treatment with immunosuppressive drugs\n8. with severe coronary or cerebrovascular disease, or other conditions that concerns the investigator for enrollment\n9. have clinical, psychological or social factors affecting informed consent or study implementation\n10. have a history of drug or peptide allergy, or allergy to other potential immunotherapies\n11. no decision making capacity for civil conduct","80 Years",{"count":175,"type":21},154,[55],"In this study, the investigators provide an individualized tumor neoantigen peptide vaccine in combination with radiotherapy to patients with advanced malignant solid tumors. The investigators observe the post-treatment tumor burden status, the immune response induced by immune preparations, and the prolongation of patient survival time, aiming to evaluate the effectiveness and safety of the individualized tumor neoantigen peptide vaccine in combination with radiotherapy",[27],[180],"Neoantigen Peptide Vaccines","2025-03-19",{"date":183,"type":36},"2025-03-25",{"date":185,"type":36},"2024-01-31",{"date":187,"type":21},"2026-08-31",{"name":189,"class":71},"The University of Hong Kong-Shenzhen Hospital"]