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Trial Title:
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
NCT ID:
NCT05727839
Condition:
Cutaneous Tumor
Malignant Solid Tumor
Conditions: Official terms:
Neoplasms
Skin Neoplasms
Conditions: Keywords:
Tumor
Intratumoral injection
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JCXH-211 Injection
Description:
JCXH-211 administered once every 28 days
Arm group label:
Phase Ia:Dose escalation
Arm group label:
Phase Ib: Dose Extension
Other name:
Intratumoral injection
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangdong
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu R hua, professor
Email:
ruihxu@163.com
Contact backup:
Last name:
ruan dan yun, physician
Phone:
13760611470
Email:
ruandy1@sysucc.org.cn
Start date:
February 24, 2023
Completion date:
August 24, 2025
Lead sponsor:
Agency:
Immorna Biotherapeutics, Inc.
Agency class:
Industry
Source:
Immorna Biotherapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05727839
