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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
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JCXH-211 Injection
Sponsored by
Immorna Biotherapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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: 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

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase Ia:Dose escalation

Phase Ib: Dose Extension

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Dose limiting toxicity
Dose limiting toxicity, evaluated in the Phase Ia, 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.
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.
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).
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

First Posted
February 1, 2023
Last Updated
March 16, 2023
Sponsor
Immorna Biotherapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05727839
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
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
July 24, 2025 (Anticipated)
Study Completion Date
August 24, 2025 (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
No
Studies a U.S. FDA-regulated Device Product
No

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 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.

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
Non-Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase Ia:Dose escalation
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase Ib: Dose Extension
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 Ia.
Intervention Type
Drug
Intervention Name(s)
JCXH-211 Injection
Other Intervention Name(s)
Intratumoral injection
Intervention Description
JCXH-211 administered once every 28 days
Primary Outcome Measure Information:
Title
Dose limiting toxicity
Description
Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.
Time Frame
Within 28 days after the first dose
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 28 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
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 ≥ 12weeks observed from Day 1 to disease progression.
Time Frame
Up to 12 months
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
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
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Wang
Phone
+8613381113913
Email
qi.wang@immorna.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xu ruihua, President
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangdong
State/Province
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu R hua, professor
Email
ruihxu@163.com
First Name & Middle Initial & Last Name & Degree
ruan dan yun, physician
Phone
13760611470
Email
ruandy1@sysucc.org.cn

12. IPD Sharing Statement

Learn more about this trial

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

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