Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
About the study
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Cutaneous Tumor,Malignant Solid Tumor
Age (in years)
18 - 75
Phase
PHASE1
Participants needed
1
Est. Completion Date
May 31, 2024
Treatment type
INTERVENTIONAL
Sponsor
Immorna Biotherapeutics, Inc.
ClinicalTrials.gov identifier
NCT05539157
Study number
2021-JCXH-211-001
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