Phase
Condition
Skin Cancer
Neoplasms
Treatment
JCXH-211 Injection
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female patients 18-75
Patients with malignant solid tumors that have been diagnosed by pathology and/orcytology
Patients who have progressed on or who cannot tolerate available therapies or forwhom 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 atleast 10mm and not exceeding 80mm)
Patients enrolled in the Skin/subcutaneous lesions and deep (visceral) lesionsstages of Phase Ia must agree to provide pre- and post-treatment tumor biopsytissues
Patients must have adequate organ and marrow functions
Patients with treated brain metastases are eligible if meeting protocol'srequirement
Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks fornitrosoureas or mitomycin C), hormonal, biological, targeted agents, otherinvestigational therapy or radiotherapy
Exclusion
Exclusion Criteria:
Patients who have received prior IL-12 either alone or as part of a treatmentregimen
Patients who have received prior therapy with an immuno-oncology agent and werediscontinued from that treatment due to a Grade 3 or higher immune-related adverseevent (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 recurrenceor active autoimmune disease that requires immunosuppressive medications
Patients who had a major surgical procedure within 4 weeks prior to the first doseof study treatment
Current or prior use of immunosuppressive medication within 2 weeks prior to thefirst dose of study treatment
Patient with history of solid organ or allogenic bone marrow transplantation
Study Design
Study Description
Connect with a study center
Sun Yat-sen University Cancer Center
Guangdong, Guangzhou 510060
ChinaSite Not Available
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia 20037
United StatesSite Not Available

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