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IMP3-saRNA Vaccine in Advanced NSCLC

NCT07561723 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-05-12

No results posted yet for this study

Summary

This is an open-label, single-arm, non-randomized, single-center, prospective phase 1 clinical trial. The study will evaluate the safety, tolerability, and preliminary antitumor activity of IMP3-saRNA (YMN-136) vaccine in patients with advanced non-small cell lung cancer.

IMP3-saRNA (YMN-136) is a vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The study will enroll patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression.

A total of 9 participants are planned to be enrolled. Participants will enter one of three dose groups sequentially: 50 micrograms, 100 micrograms, or 200 micrograms. Each dose group will include 3 participants. The study will use a 3+3 dose-escalation design. The vaccine will be administered by intramuscular injection. The immunization schedule includes 4 doses, with each dose given 3 weeks apart.

The main purpose of the study is to assess safety and tolerability. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination. Safety assessments will include adverse events, serious adverse events, physical examinations, vital signs, ECOG performance status, laboratory tests, 12-lead electrocardiogram, and echocardiography.

The study will also preliminarily assess antitumor activity using RECIST version 1.1. Imaging assessments may include CT or MRI and whole-body bone scan. Additional exploratory evaluations may include blood and tumor tissue biomarker analyses, such as ctDNA, tumor markers, immune cell subsets, dendritic cell maturation, antigen-specific cytotoxic T cells, T-cell activation, antibody titers, PD-L1 expression, gene mutation analysis, and other immune-related tests.

Conditions

Interventions

BIOLOGICAL

IMP3-saRNA (YMN-136) Vaccine

IMP3-saRNA (YMN-136) vaccine is a biological vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The vaccine will be administered by intramuscular injection. Participants will be enrolled sequentially into dose groups of 50 micrograms, 100 micrograms, and 200 micrograms using a 3+3 dose-escalation design. The basic immunization schedule includes 4 doses, with each dose given 3 weeks apart. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-04-30
Completion
2029-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561723 on ClinicalTrials.gov