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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5. — From first dose through Day 28 (±3 days) 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.
Number of participants with dose-limiting toxicities (DLTs) — From first dose through Day 28 (±3 days) The number of participants experiencing dose-limiting toxicities during the DLT evaluation period following intratumoral administration of PMC2129G12.
Maximum tolerated dose (MTD) of PMC2129G12 — Up to approximately 28 days Determination of the maximum tolerated dose (MTD) of PMC2129G12 administered by intratumoral injection based on the incidence of dose-limiting toxicities.
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.
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