[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"patients-with-advanced-solid-tumors\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:patients-with-advanced-solid-tumors":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,63,85,108],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100644013","phase-1-cw-301-fih-study-of-can016-100644013",false,"NCT07664150","CW-301 FIH Study of CAN016","A Phase I\u002FII, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Provide informed consent voluntarily\n2. Male or female patients ≥18 years of age.\n3. Patients must have a histologically or cytologically confirmed diagnosis of recurrent or metastatic HER2 expression or mutation advanced solid tumor that has failed to or intolerable with standard treatment.\n\n   1. For Phase I dose escalation, patients must have had progression of disease on an HER2 targeted ADC and should be refractory to or intolerant of exiting therapy(ies) known to provide clinical benefit for their condition;\n   2. For Phase II, patients with advanced\u002Funresectable or metastatic HER2 positive (IHC 3+, 2+\u002FISH+) breast cancer, HER2 low\u002Fultralow expression (IHC 1+, 2+\u002FISH-, IHC 0 with membrane staining) breast cancer and other HER2 expression or mutation advanced solid tumors are eligible. Patients must have had progression of disease on prior HER2 targeted ADC.\n4. At least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n5. Adequate organ function with 7 days before registration\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤1.\n7. LVEF ≥50% by either echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before registration.\n8. Life expectancy of ≥3 months.\n\nExclusion Criteria\n\n1. Patient has received any anticancer therapy (including chemotherapy, targeted therapy, hormonal therapy, biotherapy, immunotherapy, or other investigational agents.) within 28 days or 5 times of half-lives (whichever is shorter) prior to the first dose of the study treatment or who have not recovered from the side effect of such therapy.\n2. Radical radiation therapy (including radiation therapy for over 25% bone marrow) within 4 weeks prior to the first dose of the investigational product or received local palliative radiation therapy for bone metastases within 2 weeks.\n3. Patients have autologous transplantation within 3 months.\n4. Major surgery or had significant traumatic injury within 60 days prior to the first dose of the investigational product or has not recovered from major side effects.\n5. Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease.\n6. Any toxicities from prior treatment that have not recovered to baseline or ≤CTCAE Grade 1 before the start of study treatment, with exception of hair loss.","ALL","18 Years",{"count":19,"type":20},90,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","A Phase I\u002FII, Open-Label, Non-Randomized, Multi-Centre First-in-Human Study of CAN016 in Patients with Advanced Solid Tumors",[27],"Patients With Advanced Solid Tumors","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":20},"2026-06-18",{"date":36,"type":20},"2029-12-30",{"name":38,"class":39},"Canwell Biotech Limited","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":4},"100641390","phase-1-phase-i-clinical-study-of-lnf2105-in-patients-with-advanced-solid-tumors-100641390","NCT07661797","Phase I Clinical Study of LNF2105 in Patients With Advanced Solid Tumors","A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Antitumor Efficacy of LNF2105 in Patients With Advanced Solid Tumors.","Inclusion Criteria:\n\n1. Male or female aged ≥18 years.\n2. Patients with advanced solid tumors (including but not limited to urothelial carcinoma, breast cancer, non-small cell lung cancer, ovarian cancer, endometrial cancer, and cervical cancer) that have been histologically or cytologically confirmed as having failed\u002Fcannot tolerate\u002Fhave no standard treatment\u002Fare currently unsuitable for standard treatment.\n3. Able to provide previous Nectin-4 expression testing results or preserved\u002Ffresh tumor tissue for Nectin-4 expression testing.\n4. At least one measurable lesion (CT or MRI long axis ≥ 10 mm, lymph node short axis ≥ 15 mm) according to RECIST v1.1 criteria. For lesions previously treated with radiotherapy, they will only be included as measurable lesions if there has been clear disease progression after radiotherapy.\n5. The function of vital organs must meet the following requirements (no blood components or cytokines may be used within 14 days prior to the first dose).\n\n7\\) ECOG score 0-1. 8) Expected survival ≥ 3 months. 9) Willing to participate and sign informed consent form, and willing to follow the trial treatment protocol and visitation plan.\n\nExclusion Criteria:\n\n1. Prior treatment with an antibody-drug conjugate (ADC) exhibiting one of the following characteristics: payload as a topoisomerase I inhibitor (TOP 1 inhibitor); antibody target as Nectin-4.\n2. Received any P-glycoprotein (P-gp) inducer\u002Finhibitor, strong CYP3A inhibitor, or breast cancer resistance protein (BCRP) inhibitor within 14 days prior to first administration (see Appendix 3 for the exclusion list).\n3. Patients who received chemotherapy within 3 weeks or radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or other anti-tumor treatments within 4 weeks prior to first administration of the study drug, excluding the following.\n4. Patients who received systemic glucocorticoid therapy or any other form of immunosuppressive therapy (equivalent to a prednisone dose \\>10 mg\u002Fday) within 2 weeks prior to the first dose.\n5. Patients whose adverse reactions to previous antitumor therapy have not recovered to a CTCAE 5.0 grade ≤1 or the level specified in the inclusion\u002Fexclusion criteria (excluding toxicities deemed safe by the investigator, such as alopecia, grade 2 peripheral neurotoxicity, and stable hypothyroidism after hormone replacement therapy).\n6. Patients with primary central nervous system (CNS) malignancies, CNS metastases that have failed local treatment, or carcinomatous meningitis; patients with asymptomatic brain metastases, or stable clinical symptoms such as neurological symptoms and who do not require corticosteroids or other treatments targeting brain metastases for ≥4 weeks may be enrolled.\n7. Patients with uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n8. Patients with known interstitial lung disease (ILD) or non-infectious pneumonia, currently symptomatic or requiring prior systemic glucocorticoid therapy, whose toxicity assessment or management is deemed by the investigator to potentially affect the investigational treatment.\n9. Patients with a history of organ transplantation or allogeneic bone marrow transplantation, or who received autologous stem cell transplantation within 3 months prior to the first dose.\n10. Patients who underwent major surgery within 4 weeks prior to the first dose or have not yet recovered from surgery.\n11. Patients with any of the following laboratory findings.\n12. Patients with uncontrolled or severe cardiovascular disease, including those who developed NYHA Class II or higher congestive heart failure, unstable angina, myocardial infarction, or other cardiovascular diseases within 6 months prior to the first dose; or those with uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg after treatment).\n13. Patients with active infections requiring intravenous anti-infective therapy or a history of the following conditions, including but not limited to active autoimmune diseases, severe mental illness, severe endocrine disorders such as severe thyroid dysfunction.\n14. Patients with the following ocular diseases: a) active infection or corneal ulcer; b) history of corneal transplantation; c) expected contact lens wear during the study period; d) poorly controlled glaucoma; e) poorly controlled or progressive retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disease; f) or other currently existing ocular diseases that would affect the assessment of ocular toxicity after the trial intervention.\n15. Glycated hemoglobin (HbA1c) ≥ 8.0%.\n16. Suffering from severe and\u002For uncontrolled comorbidities, such as decompensated cirrhosis, nephrotic syndrome, uncontrolled metabolic disorders, active inflammatory bowel disease, gastrointestinal perforation, intestinal obstruction, or gastrointestinal bleeding.\n17. Having a bleeding tendency (e.g., abnormal coagulation function tests, clinically significant as determined by the investigator, or clinically significant bleeding symptoms as assessed by the investigator).\n18. Having received any other clinical trial drug\u002Fdevice treatment within 4 weeks prior to the first dose.\n19. Having a history of drug abuse or alcoholism within 6 months prior to the first dose.\n20. Having a history of severe allergies, or a known history of allergy to macromolecular protein preparations\u002Fmonoclonal antibodies, or to any component of the investigational drug.\n21. Having received a live or attenuated live vaccine within 4 weeks prior to the first dose.\n22. Pregnant or breastfeeding women, female participants of childbearing age, or male participants whose partners are women of childbearing age who do not agree to use medically approved effective contraception (such as an intrauterine device or condom) during the study period and for 6 months after the last study drug treatment.\n23. Individuals deemed unsuitable for enrollment by the investigator.",{"count":49,"type":20},294,[23],"This study is a Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and preliminary antitumor efficacy of LNF2105 in patients with advanced solid tumors.",[27],"NOT_YET_RECRUITING","2026-06-16",{"date":56,"type":32},"2026-06-22",{"date":58,"type":20},"2026-06",{"date":60,"type":20},"2028-08",{"name":62,"class":39},"Shandong New Time Pharmaceutical Co., LTD",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100503465","phase-1-pm534-administered-intravenously-to-patients-with-advanced-solid-tumors-100503465","NCT05835609","PM534 Administered Intravenously to Patients With Advanced Solid Tumors","Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM534 Administered Intravenously to Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n1. Voluntarily signed and dated written informed consent, obtained prior to any specific study procedure.\n2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1\n3. Patients must have:\n\n   3.1 Pathologically confirmed diagnosis of advanced solid tumors 3.2 No more than three prior chemotherapy lines.\n4. Patients with measurable or non-measurable disease according to the RECIST v.1.1.\n5. Recovery to grade ≤1 from drug-related adverse events (AEs) of previous disease treatments, excluding grade 2 alopecia.\n6. Laboratory values within seven days prior to first infusion:\n\n   1. Absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL, platelet count ≥100 x 10⁹\u002FL and hemoglobin ≥9 g\u002FdL\n   2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 x upper limit of normal (ULN).\n   3. Total bilirubin ≤ULN (up to 1.5 x ULN for patients with Gilbert's syndrome).\n   4. Creatinine clearance ≥30 mL\u002Fmin or serum creatinine ≤1.5 x ULN.\n   5. Serum albumin ≥3 g\u002FdL.\n   6. Serum potassium ≥3.5 mmol\u002FL.\n   7. Serum magnesium ≥1.6 mg\u002FdL.\n7. Wash-out periods:\n\n   1. At least three weeks since the last chemotherapy.\n   2. At least four weeks since the last monoclonal antibody (MAb)-containing therapy.\n   3. At least two weeks since the last biological\u002Finvestigational single-agent therapy (excluding MAbs) and\u002For palliative radiotherapy (RT).\n   4. In patients with hormone-sensitive breast cancer progressing while on hormone therapy (except for luteinizing hormone-releasing hormone \\[LHRH\\] analogues in pre-menopausal women or megestrol acetate), all other hormonal therapies must be stopped at least one week before study treatment start.\n   5. Castrate-resistant prostate cancer (CRPC) patients may continue receiving hormone therapy prior to and during study treatment.\n8. Life expectancy ≥3 months\n\nExclusion Criteria:\n\n1. Concomitant diseases\u002Fconditions:\n\n   1. Increased cardiac risk:\n\n      * History of long QT syndrome.\n      * Corrected QT interval (QTcF, Fridericia correction) ≥450 msec on screening electrocardiogram (ECG).\n      * History of or current ischemic heart disease, including myocardial infarction, stable\u002Funstable angina, coronary arteriography or cardiac stress testing with findings consistent with coronary occlusion or infarction or symptomatic arrhythmia.\n      * History of heart failure or left ventricular dysfunction (left ventricular ejection fraction \\[LVEF\\] ≤50%) by multiple-gated acquisition scan (MUGA) or echocardiography (ECHO).\n      * Clinically significant ECG abnormalities, including any of the following: right bundle branch block with left anterior hemiblock, second (Mobitz II) or third degree atrioventricular block and findings suggestive of ischemic heart disease.\n      * Symptomatic arrhythmia.\n      * Use of a cardiac pacemaker.\n      * History of or current peripheral vascular disease or cerebrovascular disease.\n   2. Presence of:\n\n      * Any grade of peripheral neuropathy (any etiology) at study entry.\n      * Prior history of grade ≥ 2 peripheral neuropathy due to any chemotherapeutic or investigational agent.\n      * Clinical or radiological signs of subocclusion\u002Fbowel obstruction.\n   3. Active infection requiring systemic treatment.\n   4. Known human immunodeficiency virus (HIV) or known hepatitis C virus (HCV) infection or active hepatitis B.\n   5. Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study\n2. Symptomatic, steroid-requiring, central nervous system (CNS) disease.\n3. Patients with carcinomatous meningitis.\n4. Prior bone marrow or stem cell transplantation.\n5. Current treatment with colchicine.\n6. Use of (strong or moderate) inhibitors or strong inducers of CYP3A4 activity within two weeks prior to the first infusion of PM534\n7. Known hypersensitivity to any of the components of the drug product.\n8. Limitation of the patient's ability to comply with the treatment or to follow the protocol procedures.\n9. Women who are pregnant or breast feeding and fertile patients (men and women) who are not using an effective method of contraception\n10. Patients with pulmonary lymphangitis.\n11. Use of medications with known risk of inducing torsades de pointes (TdP) within five half-lives prior to the first infusion of PM534",{"count":71,"type":20},30,[23],"The goals of this trial are to identify the dose limiting toxicities, to determine the maximum tolerated dose and the recommended dose of PM534 in patients with advanced solid tumors. All Patients will receive PM534 via intravenous.",[27],"2025-08-18",{"date":77,"type":32},"2025-08-22",{"date":79,"type":32},"2022-12-23",{"date":81,"type":20},"2026-10",{"name":83,"class":39},"PharmaMar",3,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":40},"100513787","phase-1-a-phase-iii-clinical-study-in-patients-with-advanced-solid-tumor-100513787","NCT05970016","A Phase I\u002FII Clinical Study in Patients with Advanced Solid Tumor.","A Phase I\u002FII Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.","Inclusion Criteria:\n\n1. Male or female subjects who have provided voluntary informed consent for participation in the study and to follow the protocol requirements\n2. Male or female subjects 18-70 years of age\n3. Subjects with histologically or cytologically confirmed malignant advanced solid tumors who have progressed on (or have not been able to tolerate) standard therapy or for whom no suitable effective standard therapy exists\n\n   1. For Phase I, all tumor types will be enrolled\n   2. For Phase II, Patients with DDR defects detection at central laboratory will be enrolled\n4. Subject with at least one measurable lesion according to RECIST criteria (version 1.1) for solid tumors will be allowed to include in phase II (if there is no measurable lesion but there are assessable lesions then the subject will be allowed to be included after the judgment of the investigator in phase I only)\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n6. Subjects with life expectancy of ≥12 weeks\n7. Subjects 12-lead ECG evaluation of QT level using Fridericia formula (QTcF) \\\u003C 450 mse\n8. Subjects must have the following laboratory values:\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL;\n   2. Platelet count (PLT) ≥ 100 × 109\u002FL;\n   3. Hemoglobin (HB) ≥ 9.0 g\u002FL;\n   4. No blood transfusion or hematopoietic stimulating factor treatment within 14 days;\n   5. Bilirubin total ≤ 1.5 times the upper limit of normal (ULN);\n   6. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN (In case of liver metastasis, ALT and AST ≤ 5 × ULN);\n   7. 24-hour or calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin (according to Cockcroft-Gault formula)\\*, or the 24-hour creatinine clearance measured in urine is ≥ 50 mL\u002Fmin, the patient will still be selected. \\*For CrCl value, the eligibility should be determined using the Cockcroft-Gault formula:\n\n      * Male CrCl (mL\u002Fmin) = body weight (kg) × (140 - age)\u002F\\[72 × serum creatinine (mg\u002FdL)\\]\n      * Female CrCl (mL\u002Fmin) = male CrCl × 0.85\n   8. International normalized ratio (INR) ≤ 1.5 × ULN, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;\n9. Women of childbearing potential agreed to use effective contraceptives during the study treatment period and within 3 months after the end of the study treatment period.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study based on the following criteria:\n\n1. Imaging examination suggests intracranial metastasis, which requires local treatment (in case of asymptomatic or symptomatic brain metastasis requiring no local treatment based on the investigator's judgement, the subject can still be included), or currently taking steroid hormone prior to inclusion, such as \\>10 mg prednisone (or equivalent) for intracerebral edema from brain metastases; subjects with meningeal carcinomatosis will be excluded regardless of their clinical stability\n2. History of previously received major surgery or surgical therapy for any cause within 4 weeks of the first dose; radiotherapy, chemotherapy, other clinical trial drugs or other anti-tumor treatment, within 5 half-lives or 3 weeks (whichever is shorter), prior administering the first dose of study drug on Day 1\n3. History of previous treatment with ATR inhibitors or other DDR related inhibitors (except poly ADP ribose polymerase enzyme (PARP) inhibitors)\n4. Subjects with a history of another primary malignancy other than:\n\n   1. carcinomas in situ, (e.g., breast, cervix, and prostate)\n   2. Locally excised non-melanoma skin cancer\n   3. No evidence of disease from another primary cancer for two or more years and has not taken any anti-cancer treatment in two years. Exceptions are gonadotropin-releasing hormone (GnRH) therapy for prostate cancer and hormonal maintenance therapy for breast cancer.\n5. Previously received treatment with strong CYP3A4, CYP2C8 and P-gp inhibitors or strong CYP3A4, CYP2C8 and P-gp inducers within 14 days prior to the first medication\n6. Patients with AE due to previous anti-tumor treatment that has not recovered to ≤ CTCAE grade 1 (except for alopecia, pigmentation and lymphopenia)\n7. Patients who are unable to swallow the tablets normally, or have abnormal gastrointestinal function that may affect the drug absorption, such as malabsorption syndrome or major resection of the stomach or bowels based on the judgment of the investigator\n8. Subjects with any severe and\u002For uncontrolled disease, including:\n\n   1. Poor blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg)\n   2. Myocardial infarction, arrhythmia (CTCAE grade 2 and above, also including ≥ Class II congestive heart failure (CHF) (New York Heart Association (NYHA) classification) (refer to Appendix-A)\n   3. Active infection or fever of unknown origin ≥ 38.5℃ within 7 days prior to the first medication\n   4. Active viral hepatitis; positive hepatitis B surface antigen and\u002For hepatitis B core antibody and measured HBV DNA value ≥ 500 IU\u002Fml; positive HCV antibody and measured HCV titer exceeding the upper limit of normal;\n   5. Positive Treponema pallidum antibody;\n   6. History of immunodeficiency, including positive HIV antibody or other acquired or congenital immunodeficiency diseases, or history of organ transplant;\n   7. Poor control of diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n   8. Liver disease such as decompensated liver disease\n9. Uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion as per the investigator opinion\n10. Patients with clinically significant hemorrhage symptoms or bleeding tendency within 3 months prior to the first study medication\n11. Known hypersensitivity or contraindication to any drug or any of the components of investigational product\n12. Any other clinically significant acute or chronic medical or psychiatric or any laboratory abnormality that may increase the risk associated with study drug administration or may interfere with the interpretation of study results","70 Years",{"count":94,"type":20},56,[23,24],"This is a 2-part, phase I\u002FII, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.",[98],"Patients with Advanced Solid Tumors","2025-03-18",{"date":101,"type":32},"2025-03-21",{"date":103,"type":32},"2023-08-07",{"date":105,"type":20},"2025-12-30",{"name":107,"class":39},"Beijing Tide Pharmaceutical Co., Ltd",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":40},"100469429","phase-1-abod2011-in-patients-with-advanced-solid-tumors-progressed-after-standard-systemic-therapy-100469429","NCT05392699","ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy","An Open-blind Dose Escalation Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy","Inclusion Criteria:\n\n1. 18 years and older.\n2. Understand and voluntarily sign the informed consent form (ICF).\n3. Histopathologically confirmed recurrent or metastatic solid tumors.\n4. Failure of prior systemic standard of care, or intolerance to severe toxicity, or lack of standard of care.\n5. Presence of at least one measurable lesion as assessed by RECIST Version 1.1.\n6. At least one superficial or deep lesion for intratumoral administration and biopsy.\n7. Sufficient organ functions.\n8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.\n9. Weight \\> 30 kg.\n10. Expected survival longer than 12 weeks.\n11. Evidence of menopause in female patients, or for women of childbearing potential: negative for urine or blood pregnancy.\n\nExclusion Criteria:\n\n1. Any systemic anti-tumor therapy, within 28 days prior to the first dose.\n2. Radiotherapy within 14 days prior to first dose.\n3. Use of immunosuppressants.\n4. Major surgery within 28 days.\n5. Inadequately controlled diseases.\n6. Active autoimmune and inflammatory diseases.\n7. Clinically symptomatic central nervous system tumors or metastases.\n8. Toxicity of prior anti-tumor therapy is still NCI-CTCAE ≥ 2.\n9. Other malignancies within the previous 5 years with the exception of cured basal cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the breast, and carcinoma in situ of the cervix.\n10. Active infections.\n11. Other conditions that may increase the risk associated with the study drug, or affect the study compliance, etc., which, in the opinion of the investigator, are not suitable for participation in the study.",{"count":116,"type":20},60,[23],"Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development. This product (ABOD2011) is a new generation mRNA product for intratumoral injection.\n\nThe primary objective of this study is to assess the safety and tolerability, of ABOD2011 in patients with advanced solid tumors that progressed after standard systemic therapy.",[27],"2022-06-19",{"date":122,"type":32},"2022-06-22",{"date":124,"type":32},"2022-05-25",{"date":126,"type":20},"2027-01",{"name":128,"class":129},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER"]