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

NCT07587879 | Not Yet Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: PMC2129G12-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Up to approximately 28 days

Study Arms (1)

all participants

EXPERIMENTAL

mRNA-LNP

Genetic: mRNA-LNP

Interventions

mRNA-LNP GENETIC

intratumoral mRNA-LNP administration

all participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• IntraAb, Inc.: lead

Study Sites (1)

IntraAb Inc.

Richmond, California, 94806, United States

Location

Study Officials

• Lijun Wu, MD

  IntraAb, Inc.

  STUDY CHAIR

Central Study Contacts

Lijun Wu, MD

CONTACT

5105293021; john@intraabinc.com

Lijun Lijun, MD

CONTACT

5105293021; john@intraabinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2031
• Last Updated: May 14, 2026

Record last verified: 2026-05

Locations

US (1)