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

NCT ID: NCT05727839

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-24
• Study Completion Date: 2025-08-24

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.

Conditions

Cutaneous Tumor; Malignant Solid Tumor

Study Design

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

Study Groups

Phase Ia:Dose escalation

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.

Group Type: EXPERIMENTAL

JCXH-211 Injection

Intervention Type: DRUG

JCXH-211 administered once every 28 days

Phase Ib: Dose Extension

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

Group Type: EXPERIMENTAL

JCXH-211 Injection

Intervention Type: DRUG

JCXH-211 administered once every 28 days

Interventions

JCXH-211 Injection

JCXH-211 administered once every 28 days

Intervention Type: DRUG

Other Intervention Names

Intratumoral injection

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

• 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

Principal Investigators

Xu ruihua, President

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qi Wang

Role: CONTACT

qi.wang@immorna.com

+8613381113913

Facility Contacts

Xu R hua, professor

Role: primary

ruihxu@163.com

ruan dan yun, physician

Role: backup

ruandy1@sysucc.org.cn

13760611470

Other Identifiers

JCXH-211-003

Identifier Type: -

Identifier Source: org_study_id