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Not yet recruitingNCT07587879mRNA-LNPUpdated May 14, 2026

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

A Phase 1/2 interventional study of mRNA-LNP in Advanced Solid Tumor, sponsored by IntraAb, Inc.. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by IntraAb, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Advanced Solid Tumor
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In context

Lead sponsor

This is the only study on the registry with IntraAb, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    all participants

    mRNA-LNP

    Genetic: mRNA-LNP

Interventions

  • GeneticmRNA-LNP

    intratumoral mRNA-LNP administration

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What researchers measure

Primary outcomes

  1. 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)

  2. 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)

  3. 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

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Study locations

1 site
  • IntraAb Inc.
    Richmond, California 94806, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07587879
Lead sponsor
IntraAb, Inc.
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Jan 1, 2027 (estimated)
Primary completion
Jan 1, 2030 (estimated)
Completion
Jan 1, 2031 (estimated)
Last update
May 14, 2026

Study contacts

Lijun Wu, MD
Contact
john@intraabinc.com
5105293021
Lijun Lijun, MD
Contact
john@intraabinc.com
5105293021
Lijun Wu, MD
study chair · IntraAb, Inc.

Oversight

FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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