Advanced Solid TumorPhase 1/2mRNA-LNPNCT07587879
Novel mRNA-LNP-Based Intratumoral Immunotherapy in Patients With Advanced Malignant Solid Tumors
A Phase 1/2 study testing mRNA-LNP in people with Advanced Solid Tumor, run by IntraAb, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- mRNA-LNP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jan 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Advanced Solid Tumor
- Being tested
- mRNA-LNP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-LNPGenetic
intratumoral mRNA-LNP administration
| Study group | Role | What they receive |
|---|---|---|
| all participants | Experimental | mRNA-LNP Receives: Genetic: mRNA-LNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to approximately 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IntraAb, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lijun Wu, MD, Study chair, IntraAb, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07587879
- Sponsor's protocol ID
- PMC2129G12-001
- Acronym
- mRNA-LNP
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07587879
- Acronym / sponsor ID
- mRNA-LNP / PMC2129G12-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- IntraAb, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants | Experimental | Genetic: mRNA-LNPmRNA-LNP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-LNPintratumoral mRNA-LNP administration | Genetic | all participants |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5.
Time frame: 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)
Time frame: 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 PMC2129G12
Time frame: Up 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lijun Wu, MD study chair
IntraAb, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing mRNA-LNP in people with Advanced Solid Tumor, run by IntraAb, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lijun Wu, MD (5105293021, john@intraabinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) assessed by CTCAE v5. (time frame: From first dose through Day 28 (±3 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.