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.;
Single group
JCXH-212 Injection
Biological/VaccineBased on the development principle of NCV, a community-type tumor neoantigen mRNA vaccine, JCXH-212 injection, has been developed that can be applied to patients with malignant solid tumors. NCVs activate tumor-specific CD4+ T cells and CD8+ T cells through active immunity, and these T cells can inhibit and kill tumor cells in cancer patients, thus prolonging the survival of cancer patients.
dose-limiting toxicity (DLT)
Tolerability and safety analysis: determine the maximum tolerated dose (MTD) and determine the escalation of the relevant dose. Incidence of DLTs was summarized overall and by dose level based on the DLT Analysis Set (DLTS).
analysis of primary efficacy indicators
Efficacy analysis: In the study, correlation analysis will be performed between the main efficacy indicators and dose regimen in each dose group.
exploratory analysis of changes in peripheral blood neoantigen-specific T cell responses before and after administration
Exploratory analysis: focus on describing changes in peripheral blood neoantigen-specific T cell responses before and after administration and the possible association or predictive role of such changes with treatment outcome
Click on the lead sponsor to view all of their trials.
