Back to search results

Novel mRNA-LNP-Based Intratumoral Immunotherapy for Advanced Solid Tumors

This study is testing a new treatment called PMC2129G12, which is an mRNA-LNP (messenger RNA-lipid nanoparticle) immunotherapy. It's given directly into the tumor (intratumoral) and is designed to help your own immune system fight cancer. The study is looking for people aged 18 or older with advanced solid tumors that have not responded to standard treatments. You would also need to have a specific protein called EpCAM on your tumor cells and a tumor that can be injected. The main goals are to see how safe PMC2129G12 is, what side effects it might cause, and to find the highest safe dose. The study aims to enroll 60 participants, but its current status is unclear.

Study design
This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main safety assessments will be measured from the first dose through Day 28 (approximately 4 weeks).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07587879

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

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
IntraAb, Inc.
~60 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:mRNA-LNP

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5.
Measured over From first dose through Day 28 (±3 days)
+2 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid NeoplasmEPCAM Gene

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Lijun Wu, MD · STUDY_CHAIR · IntraAb, Inc.

Who to contact

Lijun Wu, MD
[email protected]
5105293021
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5.From first dose through Day 28 (±3 days)

    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.

  • Number of participants with dose-limiting toxicities (DLTs)From first dose through Day 28 (±3 days)

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

  • Maximum tolerated dose (MTD) of PMC2129G12Up to approximately 28 days

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