This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody in patients with malignant solid tumors.
Male or female patients, aged 18 to 75 years;
General condition score ECOG 0 ~ 1;
Expected survival of more than 3 months;
Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody;
patients who have previously received IL-12 therapy (alone or as part of a treatment regimen), except those who have participated in tolerance to a single intratumoral injection;
patients who have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or have received treatment directed at another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), and discontinued treatment due to Grade 3 or higher immune-related adverse events (irAEs);
Single group
JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion
DrugJCXH-211:Tumor lesions are selected for intratumoral injection, and target or non-target lesions can be selected. The number of lesions selected for injection will be at the investigator 's discretion based on the patient' s general condition and tolerability . Anti-PD-1 antibody:Dosage and administration according to the instructions.
Dose-limiting toxicity (DLT)
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This trial is not recruiting at the moment. You can still explore other options:
