Cutaneous Tumor, Malignant Solid Tumor
Conditions
Keywords
Tumor, Intratumoral injection
Brief 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
Detailed description
The main purpose of this study is to find out how safe and tolerable the study drug, JCXH-211, is and also how well it works in people with malignant solid tumors. The study drug JCXH-211, is an immunotherapy drug. This means that it aims to work by boosting immune system's response to tumors, to help fight against the growth of the cancer cells. The study has 2 main phases: Phase 1a and Phase 1b. Phase 1a has 2 stages, skin/subcutaneous lesions stage, deep (visceral) lesions stage. Phase 1b will not start until all the data collected in Phase 1a has been completed and reviewed to check that it is safe and well tolerated.
Interventions
DRUGJCXH-211 Injection
JCXH-211 administered once every 28 days or 14days
Sponsors
Immorna Biotherapeutics, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events （Safety and Tolerability） | From consent to 28 days after the last dose of study drug | Safety and tolerability as determined by the incidence of adverse events （AEs）, including severe AEs and serious AEs （SAEs）. |
| Dose limiting toxicity | Within 28 days or 14days after the first dose | Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate （DCR） | 6 months after the last patient is enrolled. | Disease control rate is defined as the proportion of patients with CR or PR or stable disease （SD） with the DoR ≥ 12weeks observed from Day 1 to disease progression. |
| Progression-free survival （PFS） | 6 months after the last patient is enrolled. | Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier. |
| Overall survival （OS） | 6 months after the last patient is enrolled. | Overall survival is defined as the time from Day 1 until death due to any cause. |
| Objective response rate （ORR） | 6 months after the last patient is enrolled. | Objective response rate is defined as the proportion of patients that achieve a complete response （CR） or partial response （PR） during the study participation. |
| Clinical benefit rate (CBR) | 6 months after the last patient is enrolled. | Clinical benefit rate is defined as the proportion of patients with the best response of CR, PR, or SD (duration ≥ 24 weeks) throughout the study from Day 1 of treatment with the study drug to disease progression. |
| Duration of response （DoR） | 6 months after the last patient is enrolled. | 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. |
Countries
China, United States
Contacts
PRINCIPAL_INVESTIGATORXu ruihua, President
Sun Yat-Sen University Cancer Center
Outcome results
None listed