Phase I study of YKYY031 for injection in patients with advanced solid tumors
Male or female patients aged 18 to 75 years old at the time of signing the informed consent form.
Histologically or cytologically confirmed advanced or metastatic solid tumors that have failed standard therapy and have no effective treatment options, including but not limited to colorectal cancer, pancreatic cancer, etc.
Patients must have human leukocyte antigen (HLA) subtype HLA-A*11:01.
Patients must test positive for at least one of the tumor-specific antigens (TSA) targeted by YKYY031, including KRAS G12D, KRAS G12C, KRAS G12V, KRAS G13D, KRAS G12R, KRAS G12S, PIK3CA E542K, TP53 R248Q, PIK3CA E545K, BRAF V600E, PIK3CA H1047L, FBXW7 R465C.
Allergy to the investigational product (including any excipients). History of severe allergy to any drug, food, or vaccine, such as anaphylactic shock, angioneurotic edema, allergic dyspnea, anaphylactoid purpura, thrombocytopenic purpura, Arthus reaction, etc.
History of other malignancies, except for cured skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, etc., that have not recurred within 5 years prior to screening, as judged by the investigator to be eligible for enrollment.
Symptomatic central nervous system metastasis or meningeal metastasis, or other evidence indicating uncontrolled central nervous system metastasis or meningeal metastasis, as judged by the investigator to be unsuitable for enrollment. Patients with stable brain metastases (no imaging progression within 4 weeks, and not requiring corticosteroid treatment for at least 4 weeks before the first dose of the study drug) may be enrolled.
Congestive heart failure (New York Heart Association [NYHA] class > II)