A Clinical Study on the Safety and Preliminary Efficacy of IMC008 in the Treatment of CLDN18.2- Positive Advanced Solid Tumors

Changhai Hospital1 site in 1 country18 target enrollmentApril 2, 2023

ConditionsAdvanced Solid Tumor

InterventionsIMC008

DrugsIMC008

Overview

Phase: Phase 1
Intervention: IMC008
Conditions: Advanced Solid Tumor
Sponsor: Changhai Hospital
Enrollment: 18
Locations: 1
Primary Endpoint: DLT
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.

Detailed Description

This study is an open label, multi-center, dose-escalating clinical study to evaluate the safety and preliminary efficacy of IMC008 in the treatment of CLDN18.2 positive advanced solid tumors. DLTs observations will be performed 28 days after IMC008 administration. During the study, regular safety meetings will be held according to the progress of the study, and recommendations will be made on dose escalation, safety of subjects and possible study change.

Registry

clinicaltrials.gov

Start Date

April 2, 2023

End Date

March 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Changhai Hospital

Responsible Party

Principal Investigator

Luo Tianhang

Professor

Changhai Hospital

Eligibility Criteria

Inclusion Criteria

•Advanced gastric cancer /esophagogastric junction adenocarcinoma advanced pancreatic cancer.
•Tumor tissue samples of subjects expected to be available with positive for CLDN18.2 immunohistochemistry.
•The expected survival period of the subject is ≥12 weeks.
•The subject needs to have at least one target lesion that can be stably evaluated.
•The ECOG score is 0-
•Subject has adequate organ and bone marrow function
•All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-
•Fertility status : Women of childbearing age or men whose sexual partners are women of childbearing age are willing to take medically approved high-efficiency contraceptive measures.
•Subjects must sign and date written informed consent.

Exclusion Criteria

•Pregnant and lactating women.
•Known history of human immunodeficiency virus infection; acute or chronic active hepatitis B; acute or chronic active hepatitis C. Syphilis antibody positive; Epstein-Barr virus infection; CMV infection.
•Serious infection that is active or poorly controlled clinically.
•Uncontrollable pleural effusion, pericardial effusion, peritoneal effusion existed before enrollment.
•Extensive or diffuse lung metastases or extensive or diffuse liver metastases.
•Oxygen saturation ≤ 95% without oxygen inhalation.
•Suffering from other research diseases that may limit their participation in this study.
•Known past or current hepatic encephalopathy requiring treatment; patients with current or history of central nervous system disease.
•There are heart diseases that need to be treated or hypertension that is poorly controlled by the investigator, poorly controlled after standard treatment type 2 diabetes mellitus.
•Presence of any cardiac clinical symptoms or disorders.