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

NCT05727839 | Completed Phase 1

• 1 other identifier: JCXH-211-003
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 2

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

Conditions

Cutaneous Tumor; Malignant Solid Tumor

Keywords

Tumor; Intratumoral injection

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity

  Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.

  Within 28 days or 14days after the first dose

• Incidence of adverse events （Safety and Tolerability）

  Safety and tolerability as determined by the incidence of adverse events （AEs）, including severe AEs and serious AEs （SAEs）.

  From consent to 28 days after the last dose of study drug

Secondary Outcomes (6)

• Duration of response （DoR）

  6 months after the last patient is enrolled.

• Disease control rate （DCR）

  6 months after the last patient is enrolled.

• Progression-free survival （PFS）

  6 months after the last patient is enrolled.

• Overall survival （OS）

  6 months after the last patient is enrolled.

• Objective response rate （ORR）

  6 months after the last patient is enrolled.

Study Arms (1)

Dose escalation

EXPERIMENTAL

Dose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions

Drug: JCXH-211 Injection

Interventions

JCXH-211 Injection DRUG

JCXH-211 administered once every 28 days or 14days

Also known as: Intratumoral injection

Dose escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead

Study Sites (2)

The George Washington Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

Sun Yat-sen University Cancer Center

Guangdong, Guangzhou, 510060, China

Location

MeSH Terms

Conditions

Skin Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xu ruihua, President

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2023
• First Posted: February 14, 2023
• Study Start: February 24, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: March 24, 2026

Record last verified: 2024-11

Locations

CN (1); US (1)