Evaluating IMC008 for advanced solid tumors

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

This study is testing a new treatment called IMC008 to see if it is safe and effective for people with advanced solid tumors that have a specific marker called CLDN18.2.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Changhai Hospital (Academic / other)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT05837299 on ClinicalTrials.gov

What this trial studies

This is an open label, multi-center, dose-escalating clinical study aimed at assessing the safety and preliminary efficacy of IMC008 in patients with CLDN18.2 positive advanced solid tumors. The study will monitor dose-limiting toxicities (DLTs) 28 days after administration of IMC008, with regular safety meetings to evaluate the progress and make recommendations on dose escalation and subject safety. Participants will be closely monitored to ensure their health and safety throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced gastric cancer, esophagogastric junction adenocarcinoma, or advanced pancreatic cancer who have CLDN18.2 positive tumor samples.

Not a fit: Patients who are pregnant, lactating, or have certain infectious diseases such as HIV or active hepatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors that express CLDN18.2.

How similar studies have performed: While this approach is focused on a specific biomarker, similar studies targeting CLDN18.2 have shown promise in other contexts, indicating potential for success.

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 0-1.
* 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 .

Where this trial is running

Shanghai, Shanghai

• Shanghai Changhai Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Tianhang Luo, MD — Changhai Hospital
• Study coordinator: Tianhang Luo, MD

Conditions Advanced Solid Tumor