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

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

: 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 Overview

• Status: Recruiting
• Conditions: Malignant Solid Tumor; Cutaneous Tumor
• Intervention / Treatment: Drug: JCXH-211 Injection

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.

• Study Type: Interventional
• Enrollment (Anticipated): 156
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangdong, Guangzhou, China, 510060
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Contact: Xu R hua, professor; Email: ruihxu@163.com
      • Contact: ruan dan yun, physician; Phone Number: 13760611470; Email: ruandy1@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JCXH-211 Injection; JCXH-211 administered once every 28 days; Other Names: Intratumoral injection
Experimental: 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.	Drug: JCXH-211 Injection; JCXH-211 administered once every 28 days; Other Names: Intratumoral injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate （ORR）	Objective response rate is defined as the proportion of patients that achieve a complete response （CR） or partial response （PR） during the study participation.	Up to 12 months
Duration of response （DoR）	Duration of response is defined as the time from the first assessment of tumor as CR or PR to the first assessment as progressive disease or death from any cause.	Up to 12 months following first reported response
Disease control rate （DCR）	Disease control rate is defined as the proportion of patients with CR or PR or stable disease （SD） with the DoR ≥ 12weeks observed from Day 1 to disease progression.	Up to 12 months
Time to response （TTR）	Time to response is defined as the time from Day 1 until the first documentation of objective response （CR or PR）.	Up to 12 months from the start of study therapy
Progression-free survival （PFS）	Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.	Up to 12 months
Overall survival （OS）	Overall survival is defined as the time from Day 1 until death due to any cause.	Up to 24 months

Collaborators and Investigators

• Sponsor: Immorna Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2023
• Primary Completion (Anticipated): July 24, 2025
• Study Completion (Anticipated): August 24, 2025

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Tumor; Intratumoral injection
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Neoplasms; Skin Neoplasms
• Other Study ID Numbers: JCXH-211-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No