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Recruiting Phase 1/2

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

NCT06781125 · tracked via the Priya Life Science China tracker
Phase
Phase 1/2
Started
2025-05-23
Last updated
2026-11-05

Condition(s) studied

Malignant Solid Tumors

Investigational drug(s) / intervention(s)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female patients, aged 18 to 75 years; 2. 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: 3. General condition score ECOG 0 \~ 1; 4. Expected survival of more than 3 months; Exclusion Criteria: 1. Known or suspected allergy to the ingredients of the study drug or its analogues; allergic history to another monoclonal antibody; 2. 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; 3. 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);

Primary outcome measure(s)

  • Dose-limiting toxicity (DLT) — The DLT observation period is 28 days after first dose of JCXH-211 combined with anti-PD-1 antibody

Trial sites (1)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781125 on ClinicalTrials.gov ↗ ← All trials in China