A Phase I Clinical Study on the Safety, Tolerability, and Efficacy of KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma and Sarcoma)
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KXV01 TCR Lentinvivo for patients with advanced solid tumors.
• Voluntarily participate in the clinical study; fully understand the study and voluntarily sign the informed consent form; be willing to comply with and able to complete all trial procedures.
• Aged 18 to 70 years (inclusive).
• Histologically or cytologically confirmed incurable or metastatic solid tumors that have failed standard treatment, or for which no standard treatment is currently available.
• Expected survival time \> 6 months.
• ECOG performance status of 0 or 1.
• Sufficient organ function.
• Patients whose tumor lesions can be collected and from whom tumor-reactive TCR sequences can be identified may enter the study.
• Women of childbearing age must have a negative urine/blood pregnancy test during the screening period and agree to use contraceptive measures for at least 1 year after administration; male subjects whose partners are of childbearing potential must agree to use effective barrier contraception for at least 1 year after administration.
⁃ The patient's organ function and key test items at this stage should not have significant changes compared with their test results in Screening Period 1. If the patient's test results in Screening Period 2 exceed the following criteria, they should not receive administration of KXV01 Injection until the abnormal items return to the normal range.
• The patient's KXV01 Injection has been successfully prepared.
• Expected survival time \> 6 months.
• ECOG performance status of 0 or 1.
• Sufficient organ function.
• Females of childbearing potential have a negative blood pregnancy test within 7 days prior to administration of the study drug (Non-childbearing potential: surgically sterilized or postmenopausal for at least 2 years). In addition, female subjects of childbearing potential must use medically approved contraceptive measures for 12 months after the start of study treatment and have no egg retrieval during this period.
• Male subjects are willing to use medically approved contraceptive measures from the time of signing the informed consent form until 12 months after the start of study treatment, and will not donate sperm during this period.
• At least one measurable lesion according to RECIST v1.1 criteria.
• Toxicities and adverse reactions caused by prior therapy should have resolved to Grade ≤ 1 (except for toxicities considered clinically insignificant, such as chemotherapy-induced alopecia).