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

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Immorna Biotherapeutics, Inc.

Criteria

Inclusion Criteria:

All of the following conditions should be met at screening:

• 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 10 mm and not exceeding 80 mm)

• Patients enrolled in the single and multiple administration stages of Phase 1a 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 meet any of the following criteria will be excluded from study entry:

• 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