Clinical trial · Interventional
Study to Evaluate JCXH-211 as Monotherapy in Patients With Malignant Solid Tumors
A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients With Malignant Solid Tumors
NCT05727839CI-TRIAL-00106343completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
: 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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Tumor | Skin Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Solid Tumor | Malignant Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JCXH-211 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- Dose escalation study of intratumoral injection of JCXH-211 injection into cutaneous/subcutaneous lesions
- interventionNames
- Drug: JCXH-211 Injection
Primary outcomes (2)
- measure
- Dose limiting toxicity
- timeFrame
- Within 28 days or 14days after the first dose
- description
- Dose limiting toxicity, evaluated in the Phase Ia, which will be used to determine the MTD and to determine dose escalation.
- measure
- Incidence of adverse events （Safety and Tolerability）
- timeFrame
- From consent to 28 days after the last dose of study drug
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.