To Evaluate the Safety and Pharmacokinetic of SNC115 Injections in Patients With Recurrent/Refractory Small Cell Lung Cancer and Lung Large Cell Neuroendocrine Crcinoma: an Open-label, Single-arm, Dose Escalation Exploratory Study
This study is a FIH dose escalation clinical study, with single arm, open label and design, in order to observe the preliminary safety and Pharmacokinetic of SNC115 Injection in participants with Recurrent/refractory small cell lung cancer and Lung large cell neuroendocrine carcinoma.
• Age ≥ 18 years old, regardless of gender;
• Histological or cytological diagnosis of SCLC or pulmonary LCNEC (WHO 2021)
• Relapse or refractory after receiving at least first-line standard therapy, or inability to tolerate first-line standard therapy
• Eastern Cooperative Oncology Group score 0-1;
• At least one measurable tumor lesion (other than brain metastases) according to solid tumor response criteria 1.1 (RECIST1.1)
• Measurable lesions with an expected survival of more than 3 months;
• Expected survival ≥12 weeks.
• Adequate organ and bone marrow function.
• The subjects agreed to use reliable contraceptive methods for contraception within 1 year from the signing of informed consent to reinfusion.
⁃ Voluntarily participate in clinical trials and sign informed consent.