One Trial of JCXH-211 Intratumoral Injection Combined With Anti-PD-1 Antibody in Patients With Malignant Solid Tumors

NCT06781125 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: JCXH-211-006
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open-label, dose-escalation and dose-expansion Phase I /II clinical study divided into Phase I and Phase II to evaluate the safety and tolerability of JCXH-211 combined with anti-PD-1 antibody in patients with malignant solid tumors.

Conditions

Malignant Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity (DLT)

  The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody

Study Arms (1)

Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia

EXPERIMENTAL

Drug: JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion

Interventions

JCXH-211 Intratumoral Injection Combined with Anti-PD-1 Antibody IV infusion DRUG

JCXH-211:Tumor lesions are selected for intratumoral injection, and target or non-target lesions can be selected. The number of lesions selected for injection will be at the investigator 's discretion based on the patient' s general condition and tolerability . Anti-PD-1 antibody:Dosage and administration according to the instructions.

Phase Ia will be planned in 2 dose groups, Phase Ib will select the optimal dose based Phase Ia

Eligibility Criteria

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

You may qualify if:

• Male or female patients, aged 18 to 75 years;
• patients with malignant solid tumors confirmed by pathology and/or cytology who have progressed or are intolerant to standard treatment (except best supportive care); Including patients who have received prior anti-PD-1 antibody therapy; patients who have been approved as eligible for Toripalimab:
• General condition score ECOG 0 \~ 1;
• Expected survival of more than 3 months;

You may not qualify if:

• Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody;
• patients who have previously received IL-12 therapy (alone or as part of a treatment regimen), except those who have participated in tolerance to a single intratumoral injection;
• patients who have previously received treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or have received treatment directed at another stimulatory or coinhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137), and discontinued treatment due to Grade 3 or higher immune-related adverse events (irAEs);

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead

Study Officials

• RuiHua Xu

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RuiHua Xu

CONTACT

86-20-87343468; xurh@sysucc.org.cn

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: November 12, 2024
• First Posted: January 17, 2025
• Study Start: March 18, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share