Novel mRNA-LNP-Based Intratumoral Immunotherapy in Patients With Advanced Malignant Solid Tumors

Starting soon · Phase 1/Phase 2

Conditions studied: Advanced Solid Tumor

In brief

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.

Key facts

Study ID

NCT07587879

Run by

IntraAb, Inc.

People needed

60

Starts

2027-01-01

Expected to finish

2031-01-01

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IntraAb Inc. — Richmond, California, United States

Full record on ClinicalTrials.gov

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