Clinical trial · Interventional
A Study of 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
NCT05837299CI-TRIAL-00066081unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An open label, multi-center, dose-escalating study to evaluate the safety and preliminary efficacy of IMC008 in CLDN18.2 positive advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMC008 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMC008 dose 1-3
- description
- a certain number of IMC008 cell per kg will be infused
- interventionNames
- Drug: IMC008
Primary outcomes (1)
- measure
- DLT
- timeFrame
- within 28 days
- description
- To observe the incidence of dose-limiting toxicity (DLT) after IMC008 infusion
Secondary outcomes (6)
- measure
- TRAE
- timeFrame
- up to 96 weeks
- description
- To treatment-related adverse events (TRAE) and severity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 .
References
Publications (0)
Data not yet available
No reference posted for this study.