[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636556":3},{"organization":4,"armGroups":7,"interventions":53,"overallOfficials":59,"centralContacts":93,"locations":99,"responsibleParty":138,"collaborators":59,"id":140,"slug":141,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":59,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":59,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":59,"overallStatus":131,"whyStopped":59,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"West China Hospital","OTHER",[8,14,19,24,29,34,39,43,48],{"label":9,"type":10,"description":11,"interventionNames":12},"Osteosarcoma: YMN101(Part A1)","EXPERIMENTAL","Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma will be administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol.",[13],"Biological: YMN101",{"label":15,"type":10,"description":16,"interventionNames":17},"Pancreatic cancer: YMN102 (Part B1)","Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced pancreatic cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol.",[18],"Biological: YMN102",{"label":20,"type":10,"description":21,"interventionNames":22},"Head and neck squamous cell carcinoma: YMN103 (Part C1)","Patients with advanced head and neck squamous cell carcinoma (HNSCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.",[23],"Biological: YMN103",{"label":25,"type":10,"description":26,"interventionNames":27},"Colon cancer: YMN104 (Part D1)","Patients with advanced colon cancer will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.",[28],"Biological: YMN104",{"label":30,"type":10,"description":31,"interventionNames":32},"Hepatocellular carcinoma: YMN105 (Part E1)","Patients with advanced hepatocellular carcinoma (HCC) will be vaccinated via subcutaneous injection. The immunization regimen encompasses a priming phase and subsequent booster phases. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points to evaluate the safety and tolerability.",[33],"Biological: YMN105",{"label":35,"type":10,"description":36,"interventionNames":37},"Glioma: YMN106 (Part F1)","Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced glioma received intracalvariosseous (ICO) injection of the vaccine. The immunization regimen consists of a priming phase and a booster phase. Dose escalation follows a standard 3+3 design to evaluate safety and DLTs at each dose level. Participants receive the assigned cell dose via intraosseous administration during the priming phase and complete subsequent administrations at predefined intervals according to the protocol.",[38],"Biological: YMN106",{"label":40,"type":10,"description":16,"interventionNames":41},"Pancreatic cancer: YMN107 (Part G1)",[42],"Biological: YMN107",{"label":44,"type":10,"description":45,"interventionNames":46},"Breast cancer: YMN108 (Part H1)","Participants were assigned to different dose-level cohorts according to the order of enrollment, following a sequential escalation from low to high doses. Patients with advanced or recurrent metastatic breast cancer were administered the vaccine via subcutaneous injection, with the immunization regimen consisting of a priming phase and a booster phase. Dose escalation followed a standard 3+3 design to evaluate the safety and DLTs at each dose level. Participants received the assigned cell dose during the priming phase and completed subsequent administrations at predefined intervals according to the protocol.",[47],"Biological: YMN108",{"label":49,"type":10,"description":50,"interventionNames":51},"Osteosarcoma: YMN101(Part A2)","Participants will receive doses informed by the safety data and tolerability ranges established for analogous candidates in clinical studies. Patients with advanced osteosarcoma refractory to prior chemotherapy will be administered the vaccine via subcutaneous injection with concomitant regorafenib, following a priming-booster immunization regimen. Participants will be administered the corresponding doses according to a predefined allocation scheme and will complete the full vaccination cycle at prescribed time points per protocol.",[13,52],"Drug: Regorafenib",[54,60,64,68,72,76,80,84,88],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"BIOLOGICAL","YMN101","In the priming phase, subjects receive subcutaneous injections of the YMN101 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[9,49],null,{"type":55,"name":61,"description":62,"armGroupLabels":63,"otherNames":59},"YMN102","In the priming phase, subjects receive subcutaneous injections of the YMN102 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[15],{"type":55,"name":65,"description":66,"armGroupLabels":67,"otherNames":59},"YMN103","In the priming phase, subjects receive subcutaneous injections of the YMN103 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[20],{"type":55,"name":69,"description":70,"armGroupLabels":71,"otherNames":59},"YMN104","In the priming phase, subjects receive subcutaneous injections of the YMN104 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[25],{"type":55,"name":73,"description":74,"armGroupLabels":75,"otherNames":59},"YMN105","In the priming phase, subjects receive subcutaneous injections of the YMN105 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[30],{"type":55,"name":77,"description":78,"armGroupLabels":79,"otherNames":59},"YMN106","In the priming phase, subjects receive intracalvariosseous (ICO) injection of the YMN106 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[35],{"type":55,"name":81,"description":82,"armGroupLabels":83,"otherNames":59},"YMN107","In the priming phase, subjects receive subcutaneous injections of the YMN107 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[40],{"type":55,"name":85,"description":86,"armGroupLabels":87,"otherNames":59},"YMN108","In the priming phase, subjects receive subcutaneous injections of the YMN108 vaccine on Days 0, 14, and 28. During the personalized immunotherapy (boost) phase, administration occurs every 28 days at the investigator's discretion.",[44],{"type":89,"name":90,"description":91,"armGroupLabels":92,"otherNames":59},"DRUG","Regorafenib","Regorafenib at 160 mg once daily from Day 1 to Day 21, every 4 weeks (Q4W).",[49],[94],{"name":95,"role":96,"phone":97,"phoneExt":59,"email":98},"Xingchen Peng, Professor","CONTACT","+86 18980606753","pxx2014@163.com",[100,130],{"facility":101,"status":102,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":108,"geoPoint":113,"contacts":114},"West China Hospital, Sichuan University","NOT_YET_RECRUITING","Chengdu","Sichuan","610041","China","CN",{"type":109,"coordinates":110},"Point",[111,112],104.06667,30.66667,{"lat":112,"lon":111},[115,117,119,122,124,126,128],{"name":95,"role":96,"phone":116,"phoneExt":59,"email":98},"13458502834",{"name":95,"role":118,"phone":59,"phoneExt":59,"email":59},"PRINCIPAL_INVESTIGATOR",{"name":120,"role":121,"phone":59,"phoneExt":59,"email":59},"Hong Wu, Professor","SUB_INVESTIGATOR",{"name":123,"role":121,"phone":59,"phoneExt":59,"email":59},"Dan Cao, Professor",{"name":125,"role":121,"phone":59,"phoneExt":59,"email":59},"Lei Liu, Professor",{"name":127,"role":121,"phone":59,"phoneExt":59,"email":59},"Xuelei Ma, Professor",{"name":129,"role":121,"phone":59,"phoneExt":59,"email":59},"Ting Luo, Professor",{"facility":101,"status":131,"city":103,"state":104,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":132,"geoPoint":134,"contacts":135},"RECRUITING",{"type":109,"coordinates":133},[111,112],{"lat":112,"lon":111},[136],{"name":137,"role":96,"phone":116,"phoneExt":59,"email":98},"Xingchen Peng",{"type":118,"investigatorFullName":137,"investigatorTitle":139,"investigatorAffiliation":5,"oldNameTitle":59,"oldOrganization":59},"Professor","100636556","phase-1-clinical-study-of-novel-therapeutic-vaccine-for-advanced-solid-tumors-100636556",false,"NCT07567222","Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors","Safety, Tolerability, and Preliminary Antitumor Activity of Novel Therapeutic Tumor Vaccines in Advanced Solid Tumors","Inclusion Criteria\n\n1. Histologically or cytologically confirmed advanced solid tumors, or radiologically diagnosed HCC, eligible for one of the following study parts based on tumor type, clinical status, and prior treatment history:\n\n   Part A1: Patients with advanced osteosarcoma who achieved Stable Disease (SD) or Partial Response (PR) following first-line chemotherapy, and have at least one remaining lung metastatic lesion \\>= 0.5 cm.\n\n   Part A2: Patients with advanced osteosarcoma who have relapsed, metastasized, or progressed following prior chemotherapy, or who are intolerant to the toxicities of previous systemic therapy.\n\n   Part B1: Patients with advanced pancreatic cancer and disease progression following \\>= 1 prior line of standard systemic therapy.\n\n   Part C1: Patients with advanced HNSCC and disease progression following \\>= 2 prior lines of systemic therapy.\n\n   Part D1: Patients with advanced colon cancer and disease progression following \\>= 3 prior lines of therapy (including fluoropyrimidine, oxaliplatin, and irinotecan). Patients with RAS wild-type must have received EGFR inhibitors.\n\n   Part E1: Patients with advanced hepatocellular carcinoma (HCC) and disease progression following \\>= 2 prior lines of systemic therapy.\n\n   Part F1: Patients with advanced glioma and disease progression following the first-line Stupp regimen.\n\n   Part G1: Patients with advanced pancreatic cancer and disease progression following \\>= 1 prior line of therapy.\n\n   Part H1: Patients with advanced or recurrent metastatic breast cancer who have progressed on or after \\>= 3 prior lines of systemic therapy.\n2. Age 18-75 years.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2.\n4. Life expectancy \\> 3 months.\n5. Adequate organ function within 7 days prior to first dose, including:\n\n   Hematologic: Hemoglobin (Hb) \\>= 80 g\u002FL; White Blood Cell count (WBC) \\>= 3.0 x 10\\^9\u002FL; Platelet count (PLT) \\>= 80 x 10\\^9\u002FL; Absolute Neutrophil Count (ANC) \\>= 1.5 x 10\\^9\u002FL.\n\n   Hepatic: Total bilirubin \\\u003C= 1.5 x ULN (\\\u003C= 3 x ULN for liver metastases or HCC); ALT and AST \\\u003C= 2.5 x ULN (\\\u003C= 5 x ULN for liver metastases or HCC).\n\n   Renal: Creatinine clearance \\> 60 mL\u002Fmin (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) \\\u003C= 1.5 x ULN.\n6. At least one measurable or evaluable lesion per RECIST v1.1.\n7. Ability to understand and sign written informed consent and comply with study procedures.\n\nExclusion Criteria\n\n1. Another primary malignancy within 5 years prior to first dose, except for adequately treated non-melanoma skin cancer, carcinoma in situ, or localized low-risk cancers.\n2. Active central nervous system (CNS) metastases or leptomeningeal disease.\n3. Positive for infectious diseases, including HIV, active Hepatitis C (HCV RNA positive), or active Hepatitis B (HBsAg or HBcAb positive with HBV DNA \\>= 500 IU\u002FmL or \\>= 2000 copies\u002FmL).\n4. Active pulmonary tuberculosis.\n5. Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (\\> 10 mg\u002Fday prednisone equivalent) within 4 weeks prior to first dose.\n6. Major surgery or significant trauma within 28 days prior to enrollment, or presence of unhealed wounds, ulcers, or conditions associated with high risk of bleeding or perforation.\n7. Arterial\u002Fvenous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade \\>= 3 bleeding event within 28 days prior to treatment.\n8. Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration.\n9. Known hypersensitivity or intolerance to study treatment components or related compounds.\n10. Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study.\n11. Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.","ALL","18 Years","75 Years",{"count":151,"type":152},54,"ESTIMATED","INTERVENTIONAL",[155],"PHASE1","Advanced solid tumors remain a major therapeutic challenge due to their complex heterogeneity and the immunosuppressive tumor microenvironment (TME). Although cancer vaccines are designed to induce long-lasting antitumor immunity, their efficacy is often limited by the TME's immune-evasive mechanisms.\n\nBuilding on this rationale, investigators developed a novel vaccine comprising irradiated tumor cells and stromal cells isolated from adjacent non-cancerous tissues or tumor tissues in combination with adjuvant. Irradiated tumor cells in vaccines such as YMN102, YMN103, YMN104, YMN105, YMN106, and YMN107 are transfected with GM-CSF; the others, such as YMN101 and YMN108, are not transfected with GM-CSF. Preclinical studies across multiple tumor models have demonstrated potent antitumor activity with no significant toxicity observed following administration. This first-in-human Phase I study is designed to evaluate the safety and tolerability of this irradiated vaccine in patients with advanced solid tumors, alongside a preliminary assessment of its antitumor activity and immunogenic profile.\n\nThis is a first-in-human, Phase I, open-label study designed to evaluate the safety and tolerability of this novel vaccine. The study includes multiple arms targeting specific malignancies, including osteosarcoma, pancreatic cancer, HNSCC, colorectal cancer, HCC, glioma, and TNBC.\n\nThe primary objective is to determine the incidence of dose-limiting toxicities (DLTs). Secondary objectives include assessing the objective response, progression-free survival (PFS), and overall survival (OS) per RECIST v1.1. Exploratory analyses will monitor dynamic changes in circulating biomarkers and intratumoral immune modulation to identify potential predictive markers of clinical response.",[158],"Malignant Tumor","2026-06-07",{"date":161,"type":162},"2026-06-09","ACTUAL",{"date":164,"type":162},"2026-06-05",{"date":166,"type":152},"2027-06-30",{"name":5,"class":6},2]