Clinical trial · Interventional
Novel mRNA-LNP-Based Intratumoral Immunotherapy in Patients With Advanced Malignant Solid Tumors
A Phase 1/2a Clinical Study to Evaluate the Safety Tolerability, Pharmacokinetics, and Preliminary Efficacy of a Novel mRNA-LNP PMC2129G12-Based Immunotherapy in Patients With Advanced Malignant Solid Tumors
- 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)
PMC2129G12 is an investigational intratumorally administered messenger RNA-lipid nanoparticle (mRNA-LNP) immunotherapy designed to enable localized, transient expression of a humanized EpCAM-targeted CD3-engaging bispecific antibody together with the immunostimulatory cytokines to kill tumors by recruited immune T cells.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mRNA-LNP | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- all participants
- description
- mRNA-LNP
- interventionNames
- Genetic: mRNA-LNP
Primary outcomes (3)
- measure
- Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5.
- timeFrame
- From first dose through Day 28 (±3 days)
- description
- The number of participants experiencing treatment-emergent adverse events following intratumoral administration of PMC2129G12, graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
- measure
- Number of participants with dose-limiting toxicities (DLTs)
- timeFrame
- From first dose through Day 28 (±3 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \>18 years * Histologically or cytologically confirmed advanced or metastatic solid tumor refractory to standard therapy * EpCAM expression ≥2+ intensity in ≥50% of tumor cells by central IHC * At least one measurable lesion per RECIST v1.1 (≥2 cm) that is anatomically accessible for intratumoral injection * ECOG performance status 0-1 * Life expectancy ≥3 months * Adequate hematologic, hepatic, renal, and coagulation function * Willingness to use effective contraception Exclusion Criteria: * Prior EpCAM- or CD3-targeted therapy * Active autoimmune disease requiring systemic therapy * Uncontrolled infection or significant cardiovascular disease * Active or symptomatic CNS metastases requiring immediate local therapy. Patients with treated, stable CNS metastases may be eligible. * Ongoing ≥Grade 2 toxicity from prior anticancer therapy * Known hypersensitivity to study drug components * Pregnancy or breastfeeding
References
Publications (0)
Data not yet available