Advanced malignant solid tumor
Conditions
Interventions
YMN101(Part A1):Novel Therapeutic Cancer Vaccine
YMN101 and Regorafenib(Part A2):Novel Therapeutic Cancer Vaccine
YMN102(Part B1):Novel Therapeutic Cancer Vaccine
YMN103(Part C1):Novel Therapeutic Cancer Vaccine
YMN104(Part D1):Novel Therapeutic Cancer Vaccine
YMN105(Part E1):Novel Therapeutic Cancer Vaccine
YMN106(Part F1):Novel Therapeutic Cancer Vaccine
YMN107(Part G1):Novel Therapeutic Cancer Vaccine
YMN108(Part H1):Novel Therapeutic Cancer Vaccine
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 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: 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. 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. Part B1: Patients with advanced pancreatic cancer and disease progression following >= 1 prior line of standard systemic therapy. Part C1: Patients with advanced HNSCC and disease progression following >= 2 prior lines of systemic therapy. 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. Part E1: Patients with advanced hepatocellular carcinoma (HCC) and disease progression following >= 2 prior lines of systemic therapy. Part F1: Patients with advanced glioma and disease progression following the first-line Stupp regimen. Part G1: Patients with advanced pancreatic cancer and disease progression following >= 1 prior line of therapy. Part H1: Patients with advanced or recurrent metastatic breast cancer who have progressed on or after >= 3 prior lines of systemic therapy. 2. Age 18-75 years 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 4. Life expectancy > 3 months. 5. Adequate organ function within 7 days prior to first dose, including: Hematologic: Hemoglobin (Hb) >= 80 g/L; White Blood Cell count (WBC) >= 3.0 x 10^9/L; Platelet count (PLT) >= 80 x 10^9/L; Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L. Hepatic: Total bilirubin 60 mL/min (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) <= 1.5 x ULN. 6. At least one measurable or evaluable lesion per RECIST v1.1. 7. Ability to understand and sign written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Active central nervous system (CNS) metastases or leptomeningeal disease. 3. 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/mL or >= 2000 copies/mL). 4. Active pulmonary tuberculosis 5. Active autoimmune disease requiring systemic treatment within the past 2 years; or use of systemic corticosteroids (> 10 mg/day prednisone equivalent) within 4 weeks prior to first dose. 6. 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. 7. Arterial/venous thrombosis or pulmonary embolism within 6 months, or CTCAE Grade >= 3 bleeding event within 28 days prior to treatment. 8. Localized conditions at the injection site (e.g., infection, inflammation, or extensive scarring) or clinically significant coagulation disorders that contraindicate subcutaneous or intraosseous administration. 9. Known hypersensitivity or intolerance to study treatment components or related compounds. 10. Pregnant or breastfeeding, or planning to conceive (participant or partner) during the study 11. Any condition that, in the investigator's judgment, may compromise safety or interfere with study participation or evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactPeng Xingchen
West China Hospital, Sichuan University
Outcome results
None listed