An Open, Single-center, Multiple-dose, Dose-increasing and Dose-expanding Clinical Study to Observe and Evaluate the Safety, Tolerance, Immunokinetics and Preliminary Effectiveness of ABOR2014 Injection (IPM511) in the Treatment of Advanced Hepatocellular Carcinoma

Peking Union Medical College Hospital1 site in 1 country48 target enrollmentJuly 10, 2023

ConditionsAdvanced Hepatocellular Carcinoma

InterventionsNeoantigen vaccine, I.M injection

DrugsNeoantigen vaccine, I.M injection

Overview

Phase: Not Applicable
Intervention: Neoantigen vaccine, I.M injection
Conditions: Advanced Hepatocellular Carcinoma
Sponsor: Peking Union Medical College Hospital
Enrollment: 48
Locations: 1
Primary Endpoint: Clinically significant abnormal changes in vital signs
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open label, single-site, investigator-initiated trial designed to evaluate the safety, tolerability and preliminary efficacy of ABOR2014(IPM511) injection in relapsed/ refactory HCC.

Registry

clinicaltrials.gov

Start Date

July 10, 2023

End Date

December 31, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Peking Union Medical College Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who understand and voluntarily sign the informed consent form;
•Male or female subjects ≥ 18 years old;
•Patients with pathological or cytological evidence of locally advanced or hepatocellular carcinoma, who have failed or are intolerant of previous standard treatments;
•At least one measurable lesion judged according to the RECIST version 1.1 standard.
•Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 (inclusive);
•Life expectancy ≥ 12 weeks;
•HLA typing: A-02;
•Laboratory tests at screening shall meet the following requirements:
•Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
•Platelet count (PLT) ≥ 90 × 10\^9/L;

Exclusion Criteria

•Known allergy to any of the components of the investigational product;
•History of topical treatment with mRNA products or treatment with mRNA vaccines;
•Patients with a history of major operations within 4 weeks before the first dose, have a plan of major operations during the study (at the investigator's discretion);
•History of anti-tumor therapies within 4 weeks before the first dose;
•History of receiving immunosuppressive drugs within 4 weeks before the first dose, except for corticosteroid nasal sprays, inhalants, and systemic prednisone at a dose of ≤ 10 mg/day or similar drugs at equivalent doses;
•History of organ transplant, bone marrow transplant, or hematopoietic stem cell transplant;
•History of hemorrhagic diseases such as anaphylactoid purpura, Haemophilia and aplastic anemia;
•History of live attenuated vaccines within 30 days before the first dose;
•Central nervous system (CNS) metastases that are symptomatic, untreated, or require continuous treatment;
•Toxicological events (except alopecia and pigmentation) have not recovered to baseline or NCI-CTCAE v5.0 grade 0-1 after prior anti-tumor therapies;