Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

Launched by IMMORNA BIOTHERAPEUTICS, INC. · Feb 6, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called JCXH-211, which is given as an injection directly into tumors. The goal of the trial is to see how safe the treatment is, how well it works, and how patients tolerate it. It is open to adults between the ages of 18 and 75 who have been diagnosed with certain types of malignant solid tumors, which means tumors that can grow aggressively. To participate, patients must have already tried other treatments that didn't work or couldn't be tolerated, and they should have measurable tumors that can be injected.

Participants in the trial will receive the JCXH-211 injections and will be closely monitored for any side effects and how effective the treatment is. It’s important to note that patients with certain medical histories or conditions, such as recent major surgeries or autoimmune diseases, may not be eligible to join. If you're interested in learning more about this study and whether you might qualify, please reach out to your healthcare provider for further information.

Gender

ALL

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