Advanced Solid Tumors
Conditions
Interventions
Dose Escalation Arm:XP-001-V2 ,Q3W,up to 9 treatment cycles
Dose Expansion Arm:XP-001-V2,Appropriate Dose,Q3W,up to 9 treatment cycles
Sponsors
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign the informed consent form and are willing to follow the protocol regulations; 2. Age>=18 years old, gender is not limited; 3. Expected survival >=6 months; 4. Patients with histologically or cytologically confirmed advanced solid tumors that have failed standard therapy, including but not limited to: a) Pancreatic cancer: Patients with histologically or cytologically confirmed pancreatic malignancy, considered inoperable advanced stage, metastasis, or recurrent by imaging evaluation, and at least failed or intolerant to first-line therapy; b) Colorectal cancer: patients with microsatellite stable (MSS) metastatic advanced colorectal cancer line II or above (failure of line I therapy); c) Lung cancer: patients with advanced non-small cell lung cancer who have failed at least I line standard therapy; d) Other solid tumors that have failed standard therapy; 5. After sequencing and bioinformatics analysis, it is found that the tumor tissue carries the KRAS G12V mutation (the test report in the past 12 months approved by the investigator is acceptable), and at least one HLA that can effectively present the antigen (HLA-A11:01, HLA-A03:01, HLA-A30:01, HLA-A68:01, HLA-C01:02, HLA-C03:03, HLA-C03:04) is required in the dose expansion phase; 6. According to the efficacy evaluation criteria of solid tumors, RECIST version 1.1, at least one measurable lesion; 7. ECOG physical status score of 0 or 1 point; 8. Hematological indicators: White blood cell count (WBC) >=3.0×10^9/L within 14 days before screening without blood transfusion, granulocyte colony-stimulating factor (G-CSF) treatment, and drug correction; Absolute lymphocyte value (ALC) > = 0.7×10^9/L; Absolute neutrophil value (ANC) > = 1.0×10^9/L; Red blood cell count (RBC) > = 2.5×10^9/L; Hemoglobin (Hb) > = 90 g/L; Platelet count (PLT) > = 80×10^9/L; 9. Biochemical indicators: total bilirubin (TBIL) < = 1.5× upper limit of normal value (ULN), AST and ALT< = 2.5× ULN (relaxed to < = 5× ULN for those with tumor liver metastases), serum creatinine (Cr) <=1.5× ULN; 10. Male subjects must agree to use protocol-specified contraceptive measures and refrain from sperm donation during the trial and for at least 180 days after the last treatment; 11. Female subjects must be non-pregnant, non-lactating, or of non-childbearing potential, and if of childbearing potential, they must agree to use contraceptive measures as specified in the protocol during the trial and at least 180 days after the last treatment, and women of childbearing potential have a negative blood pregnancy test within 72 hours before enrollment;
Exclusion criteria
Exclusion criteria: 1. Those who are in the active infection period and need treatment; 2. Those with unstable brain metastasis or symptoms of brain metastasis (except for patients with stable brain metastases within 4 weeks before enrollment); 3. Those who have interstitial lung disease in the past or at the time of enrollment; 4. Those with extensive lung metastases that cause dyspnea; 5. Patients whose tumors are close to or invade large blood vessels or nerves; 6. History of severe cardiovascular and cerebrovascular diseases, including but not limited to ventricular arrhythmias requiring clinical intervention; Acute coronary syndrome, myocardial infarction, congestive heart failure, stroke, or other grade III or above cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function classification > class II or left ventricular ejection fraction (LVEF) 160mmHg, diastolic blood pressure > even with standard treatment 90mmHg); 7. Patients with a history of organ transplantation or waiting for organ transplantation; 8. Prior treatment with immunomodulatory drugs within 4 weeks prior to the first dose, including but not limited to: IL-2, CTLA-4 inhibitors, PD-1/PD-L1 inhibitors, CD40 agonists, CD137 agonists, IFN-a (except for high-risk surgical patients using IFN-a as adjuvant therapy, unless IFN-a therapy is discontinued within 4 weeks prior to this trial); 9. Those who have participated in other clinical studies and used clinical trial drugs or devices within 1 month before enrollment; 10. Diagnosed with immunodeficiency disease or concomitant use of steroid hormone drugs (daily dose of more than 10mg prednisone equivalent) or other immunosuppressive therapy within 7 days before the first dose; 11. Those who have received chemotherapy, radiotherapy, or biological therapy within 4 weeks before the first dose; 12. Use of non-cytotoxic small molecule drugs within 2 weeks or within 5 half-lives (whichever is longer) before the first dose; 13. Adverse reactions of previous anti-tumor therapy before administration have not recovered to CTCAE version 5.0 grade evaluation <=1, except for the following situations: a) hair loss; b) pigmentation; c) Treatment-induced long-term toxicity, which cannot be recovered by the investigator's judgment; 14. Those who have received other anti-infective non-tumor vaccines within 4 weeks before the first dose, or who are expected to use other non-tumor vaccines during this tumor vaccination process (if necessary, it must be at least eight weeks after the completion of the last dose of tumor vaccination); 15. Those who have received live virus vaccine within 30 days before the first dose; 16. Known or suspected autoimmune disease, or immunosuppressed; Exceptions may be made to vitiligo, type I diabetes, autoimmune-related hypothyroidism requiring hormone replacement therapy, or psoriasis not requiring systemic treatment; 17. Those who have undergone surgery and have not recovered or are suspected of having infection, those who underwent surgery with general anesthesia within 2 weeks before administration, and those who underwent surgery with local/epidural anesthesia within 72 hours before administration; 18. History of other malignant tumors; However, the following exceptions may be made: (A) if the disease has been disease-free for at least 5 years and the risk of recurrence of the malignancy is considered low by the investigator; (B) Diag
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Imaging Examinations;Immunogenicity; | — |
Countries
China
Contacts
Public ContactShen Boyong/Sun Jing
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed