Novel mRNA-LNP-Based Intratumoral Immunotherapy in Patients With Advanced Malignant Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mRNA-LNP.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
This Phase 1/2a, open-label study is designed to evaluate the safety and tolerability of PMC2129G12 encoding humanized EpCAM-targeted CD3-engaging bispecific antibody together with the immunostimulatory cytokines administered by intratumoral injection in patients with EpCAM-positive advanced malignant solid tumors. Secondary and exploratory objectives include characterization of pharmacokinetics, pharmacodynamic immune effects, and preliminary antitumor activity. The study will provide critical information to support further clinical development of PMC2129G12 as a novel intratumoral immunotherapy for patients with advanced epithelial cancers.
Interventions
- Genetic mRNA-LNP
intratumoral mRNA-LNP administration
Primary outcome measures
- Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5. [Time frame: From first dose through Day 28 (±3 days)]
- Number of participants with dose-limiting toxicities (DLTs) [Time frame: From first dose through Day 28 (±3 days)]
- Maximum tolerated dose (MTD) of PMC2129G12 [Time frame: Up to approximately 28 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- IntraAb Inc. — Richmond
Identifiers
NCT: NCT07587879 · PMC2129G12-001