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: Active, not recruiting
• Conditions: Malignant Solid Tumor; Cutaneous Tumor
• Intervention / Treatment: Drug: JCXH-211

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JCXH-211; JCXH-211 administered once every 28 days
Experimental: 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.	Drug: JCXH-211; JCXH-211 administered once every 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose limiting toxicity	Dose limiting toxicity, evaluated in the single administration stage of Phase 1a, which will be used to determine the MTD and to determine dose escalation	Day 1 to Day 29
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 30 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
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
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 ≥ 12 weeks observed from Day 1 to disease progression.	Up to 12 months
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): October 18, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: April 3, 2023
• Last Verified: April 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: 2021-JCXH-211-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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