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

NCT ID: NCT05539157

Last Updated: 2023-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-18
• Study Completion Date: 2024-05-31

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 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.

Conditions

Cutaneous Tumor; Malignant Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a:Dose escalation

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.

Group Type: EXPERIMENTAL

JCXH-211

Intervention Type: DRUG

JCXH-211 administered once every 28 days

Phase 1b:Dose expansion

JCXH-211 will be delivered by intratumoral injection. The dose to be used will be determined after review of the data from Phase 1a.

Group Type: EXPERIMENTAL

JCXH-211

Intervention Type: DRUG

JCXH-211 administered once every 28 days

Interventions

JCXH-211

JCXH-211 administered once every 28 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

All of the following conditions should be met at screening:

• 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 10 mm and not exceeding 80 mm)
• Patients enrolled in the single and multiple administration stages of Phase 1a 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 meet any of the following criteria will be excluded from study entry:

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Immorna Biotherapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Other Identifiers

2021-JCXH-211-001

Identifier Type: -

Identifier Source: org_study_id