A Study of IMC008 for Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2026-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Changhai Hospital

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 0-1.

• Subject has adequate organ and bone marrow function

• All toxic reactions caused by previous anti-tumor therapy were relieved to grade 0-1.

• 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.

• Evidence of significant coagulopathy or other significant bleeding risk.

• Received systemic steroids equivalent to >15 mg/ day prednisone cumulatively for more than 3 days within 2 weeks prior to apheresis , excluding inhaled steroids.

• Prior or concurrent occurrence of other malignancies, with the following exceptions.

• Subjects who have previously received other gene therapy.

• Allergic/ intolerance to lymphodepletion regimen or CRS treatment drugs or IMC008.

• Subjects with severe mental disorders.

• The investigator assessed the subject's inability or unwillingness to comply with the requirements of the study protocol .