Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
Cutaneous Tumor, Malignant Solid Tumor
About this trial
This is an interventional treatment trial for Cutaneous Tumor focused on measuring Tumor, Intratumoral injection
Eligibility Criteria
Inclusion Criteria: Male or female patients 18-75 Patients with malignant solid tumors that have been diagnosed by pathology and/or cytology Patients who have progressed on or who cannot tolerate available therapies or for whom curative therapy does not exist Patients with at least one non-injected measurable tumor lesion per RECIST v1.1 Patients with lesions suitable for intratumoral injection (the lesion length is at least 10mm and not exceeding 80mm) Patients enrolled in the Skin/subcutaneous lesions and deep (visceral) lesions stages of Phase Ia must agree to provide pre- and post-treatment tumor biopsy tissues Patients must have adequate organ and marrow functions Patients with treated brain metastases are eligible if meeting protocol's requirement Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy Exclusion Criteria: Patients who have received prior IL-12 either alone or as part of a treatment regimen Patients who have received prior therapy with an immuno-oncology agent and were discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE) Patients requiring therapeutic doses of anticoagulation Patients with tumors that impinge on major airways, blood vessels, or nerve bundles Patients with a history of autoimmune disease that has the possibility of recurrence or active autoimmune disease that requires immunosuppressive medications Patients who had a major surgical procedure within 4 weeks prior to the first dose of study treatment Current or prior use of immunosuppressive medication within 2 weeks prior to the first dose of study treatment Patient with history of solid organ or allogenic bone marrow transplantation
Sites / Locations
- Sun Yat-sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase Ia:Dose escalation
Phase Ib: Dose Extension
JCXH-211 will be delivered by intratumoral injection in 2 stages: (Part1)Intratumoral injection stage of skin/subcutaneous lesions. According to Part 1 study results,1-2 dose groups were selected for deep lesion injection study, dose escalation will follow the "3 + 3" principle.
JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase Ia.