To evaluate the safety and tolerability of JCXH-212 monotherapy and combined with Toripalimab in patients with malignant solid tumors; to determine the maximum tolerated dose (MTD), and to evaluate the dose-limiting toxicity (DLT) of JCXH-212 monotherapy and combined with Toripalimab.
male or female patients, aged 18 ~ 75 years old;
patients with advanced malignant solid tumors who have failed standard treatment (progression or intolerance after treatment) confirmed by pathology and/or cytology (only for Part 1);
only for part2 : A. Patients with initial treatment, refusing or intolerant of standard treatment, PD-L1 (IHC 22C3) TPS ≥ 1%; B. Stage IIIB-IV patients with disease progression after previous standard treatment, who intend to receive immune monotherapy, can be enrolled regardless of the results of PD-L1; C. Stage II-III NSCLC patients after radical surgery, postoperative adjuvant chemotherapy (if necessary) has been completed, and PD-L1 (IHC 22c3) TPS is ≥ 1%, intend to receive adjuvant immunotherapy.
tumor biopsy tissue samples can be provided for tumor neoantigen detection;
Those meeting any of the following conditions may not be included.
Known or suspected hypersensitivity to the ingredients of the study drug or its analogues;
Only for Part 2: adverse reactions of grade ≥3 occurred after using ICIs in the past; except maculopapules /itching and reactive cutaneous capillary hyperplasia (RCCEP), there is no need to stop ICIs in hypothyroidism. Or those who are at high risk of receiving ICI treatment.
Patients with any other disease or medical condition that is unstable or may affect their safety or study compliance, any serious or uncontrolled systemic disease, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, active gastrointestinal ulcers, abnormal immune function, etc.;