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

Primary Purpose

Cutaneous Tumor, Malignant Solid Tumor

Status

Active

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

JCXH-211

About this trial

This is an interventional treatment trial for Cutaneous Tumor focused on measuring Tumor, Intratumoral injection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Phase 1a:Dose escalation

Phase 1b:Dose expansion

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

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)

Secondary Outcome Measures

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.

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.

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).

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.

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.

Overall survival (OS)

Overall survival is defined as the time from Day 1 until death due to any cause.

Full Information

NCT ID

NCT05539157

First Posted

August 30, 2022

Last Updated

April 3, 2023

Sponsor

Immorna Biotherapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT05539157

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 18, 2022 (Actual)

Primary Completion Date

March 2024 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immorna Biotherapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Tumor, Malignant Solid Tumor

Keywords

Tumor, Intratumoral injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Phase 1a:Dose escalation

Arm Type

Experimental

Arm Description

Arm Title

Phase 1b:Dose expansion

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

JCXH-211

Intervention Description

JCXH-211 administered once every 28 days

Primary Outcome Measure Information:

Title

Dose limiting toxicity

Description

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

Time Frame

Day 1 to Day 29

Title

Incidence of adverse events (Safety and Tolerability)

Description

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

Time Frame

From consent to 30 days after the last dose of study drug

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

Objective response rate is defined as the proportion of patients that achieve a complete response (CR) or partial response (PR) during the study participation.

Time Frame

Up to 12 months

Title

Duration of response (DOR)

Description

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.

Time Frame

Up to 12 months following first reported response

Title

Time to response (TTR)

Description

Time to response is defined as the time from Day 1 until the first documentation of objective response (CR or PR).

Time Frame

Up to 12 months from the start of study therapy

Title

Disease control rate (DCR)

Description

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.

Time Frame

Up to 12 months

Title

Progression-free survival (PFS)

Description

Progression-free survival is defined as the time from Day 1 to disease progression or death from any cause, whichever occurs earlier.

Time Frame

Up to 12 months

Title

Overall survival (OS)

Description

Overall survival is defined as the time from Day 1 until death due to any cause.

Time Frame

Up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

The University of Texas MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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