A Phase 1 interventional study of JCXH-211 in Cutaneous Tumor and Malignant Solid Tumor, sponsored by Immorna Biotherapeutics, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Immorna Biotherapeutics, Inc. · Phase 1, Interventional, and Treatment
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors
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 3 stages, Single administration stage, Multiple administration stage and Visceral 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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 1 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Immorna Biotherapeutics, Inc. is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
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All of the following conditions should be met at screening:
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from study entry:
JCXH-211 will be delivered by intratumoral injection in 3 stages: Single administration stage A single administration of JCXH-211 administered to cutaneous or subcutaneous lesions in escalating doses. Multiple administration stage Up to 3 doses of JCXH-211 administered to a cutaneous or subcutaneous lesion in escalating doses. Assigned dose to be determined on the data from the single administration arm. Visceral administration stage JCXH-211 administered to a visceral lesion in escalating doses. Assigned dose to be determined on the data from the single and multiple administration arms.
Drug: JCXH-211
JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a.
Drug: JCXH-211
JCXH-211 administered once every 28 days
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
Time frame: Day 1 to Day 29
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)
Time frame: From consent to 30 days after the last dose of study drug
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months following first reported response
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).
Time frame: Up to 12 months from the start of study therapy
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
Overall survival (OS)
Overall survival is defined as the time from Day 1 until death due to any cause.
Time frame: Up to 24 months
Plan to share: No
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This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Immorna Biotherapeutics, Inc.