Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors

Immorna Biotherapeutics

Status and phase: Enrolling; Phase 1

Conditions: Cutaneous Tumor; Malignant Solid Tumor

Treatments: Drug: JCXH-211 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05727839

JCXH-211-003

Details and patient eligibility

About

: A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

Full 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.

Enrollment: 156 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

156 participants in 2 patient groups

Phase Ia:Dose escalation

Experimental group

Description:

JCXH-211 will be delivered by intratumoral injection in 2 stages: （Part1）Intratumoral injection stage of skin/subcutaneous lesions. According to Part 1 study results,1-2 dose groups were selected for deep lesion injection study, dose escalation will follow the "3 + 3" principle.

Treatment:

Drug: JCXH-211 Injection

Phase Ib: Dose Extension

Experimental group

Description:

JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase Ia.

Treatment:

Drug: JCXH-211 Injection