Malignant Solid Tumor Clinical Trial
Official title:
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors
Verified date | April 2023 |
Source | Immorna Biotherapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
Status | Active, not recruiting |
Enrollment | 1 |
Est. completion date | May 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Immorna Biotherapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Dose limiting toxicity | Dose limiting toxicity, evaluated in the single administration stage of Phase 1a, which will be used to determine the MTD and to determine dose escalation | Day 1 to Day 29 | |
Primary | Incidence of adverse events (Safety and Tolerability) | Safety and tolerability as determined by the incidence of adverse events (AEs), including severe AEs and serious AEs (SAEs) | From consent to 30 days after the last dose of study drug | |
Secondary | Objective response rate (ORR) | Objective response rate is defined as the proportion of patients that achieve a complete response (CR) or partial response (PR) during the study participation. | Up to 12 months | |
Secondary | Duration of response (DOR) | Duration of response is defined as the time from the first assessment of tumor as CR or PR to the first assessment as progressive disease or death from any cause. | Up to 12 months following first reported response | |
Secondary | Time to response (TTR) | Time to response is defined as the time from Day 1 until the first documentation of objective response (CR or PR). | Up to 12 months from the start of study therapy | |
Secondary | Disease control rate (DCR) | Disease control rate is defined as the proportion of patients with CR or PR or stable disease (SD) with the DOR = 12 weeks observed from Day 1 to disease progression. | Up to 12 months | |
Secondary | Progression-free survival (PFS) | Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier. | Up to 12 months | |
Secondary | Overall survival (OS) | Overall survival is defined as the time from Day 1 until death due to any cause. | Up to 24 months |
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