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

Phase 2Not Yet RecruitingNCT07587879

IntraAb, Inc.60 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Solid Tumor

Interventions

mRNA-LNPGENETIC

intratumoral mRNA-LNP administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

IntraAb Inc.

Richmond, California, United States

Outcomes

Primary Outcomes

Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5.

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.

Time frame: From first dose through Day 28 (±3 days)

Number of participants with dose-limiting toxicities (DLTs)

The number of participants experiencing dose-limiting toxicities during the DLT evaluation period following intratumoral administration of PMC2129G12.

Time frame: From first dose through Day 28 (±3 days)

Maximum tolerated dose (MTD) of PMC2129G12

Determination of the maximum tolerated dose (MTD) of PMC2129G12 administered by intratumoral injection based on the incidence of dose-limiting toxicities.

Time frame: Up to approximately 28 days

Central Contacts

Lijun Wu, MD

CONTACT

5105293021 john@intraabinc.com

Lijun Lijun, MD

CONTACT

5105293021 john@intraabinc.com

Data from ClinicalTrials.gov

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