This study is the first human, open label, dose escalation, and expansion phase I clinical trial aimed at evaluating the safety, tolerability, preliminary efficacy, pharmacokinetic characteristics, biomarker changes, and immunogenicity of CEL001 injection in the treatment of advanced solid tumors.
Age ≥ 18 years old, gender not limited;
ECOG physical fitness status score: 0-1 points;
Subjects with advanced or metastatic tumors diagnosed by histology or cytology, who have failed* or unable to tolerate standard treatment according to CSCO guidelines or NCCN guidelines, or lack effective treatment methods;
Male subjects should weigh no less than 50 kilograms, and female subjects should weigh no less than 45 kilograms;
Individuals allergic to any component of CEL001 injection, including those allergic to penicillin;
Have received anti-tumor treatments such as chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, or participated in other clinical trials within 4 weeks or 5 known drug half lives (whichever is shorter) before the first use of the investigational drug;
Have received traditional Chinese medicine or modern Chinese medicine preparations with anti-tumor indications in the instructions within 14 days before the first administration;
Within the past 5 years, have had malignant tumors other than those treated in this study (excluding cured thyroid cancer, basal cell carcinoma of the skin, and cervical carcinoma in situ);