Clinical trial NCT05727839: Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cutaneous Tumor
Malignant Solid Tumor
Keywords: Tumor
Intratumoral injection
Lead sponsor: Immorna Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dose limiting toxicity
timeFrame: Within 28 days after the first dose
measure: Incidence of adverse events （Safety and Tolerability）
timeFrame: From consent to 28 days after the last dose of study drug
Secondary outcomes:
measure: Objective response rate （ORR）
timeFrame: Up to 12 months
measure: Duration of response （DoR）
timeFrame: Up to 12 months following first reported response
measure: Disease control rate （DCR）
timeFrame: Up to 12 months
measure: Time to response （TTR）
timeFrame: Up to 12 months from the start of study therapy
measure: Progression-free survival （PFS）
timeFrame: Up to 12 months
measure: Overall survival （OS）
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Guangdong
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangzhou
Study officials:
affiliation: Sun Yat-sen University
name: Xu ruihua, President
role: PRINCIPAL_INVESTIGATOR
References: