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

NCT05539157 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 2021-JCXH-211-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 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 Outcomes (6)

• Objective response rate (ORR)

  Up to 12 months

• Duration of response (DOR)

  Up to 12 months following first reported response

• Time to response (TTR)

  Up to 12 months from the start of study therapy

• Disease control rate (DCR)

  Up to 12 months

• Progression-free survival (PFS)

  Up to 12 months

Study Arms (2)

Phase 1a:Dose escalation

EXPERIMENTAL

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

Phase 1b:Dose expansion

EXPERIMENTAL

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

Interventions

JCXH-211 DRUG

JCXH-211 administered once every 28 days

Phase 1a:Dose escalation; Phase 1b:Dose expansion

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead

Study Sites (1)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Skin Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 14, 2022
• Study Start: October 18, 2022
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)