Clinical trial · Interventional
Safety and Tolerability Study of Claudiximab in Patients With Advanced Gastroesophageal Cancer
Clinical First-in-human Single-dose Escalation Study Evaluating the Safety and Tolerability of Claudiximab (iMAB-362) in Hospitalized Patients With Advanced Gastroesophageal Cancer. A Multi-center, Phase I, Open-label, i.v. Infusion Study
- 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)
Claudiximab is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. Preclinically, claudiximab was shown to inhibit tumor growth and to kill cancer cells by indirect (complement-dependent cytoxicity, antibody-dependent cellular cytotoxicity) and direct mechanisms (antiproliferative and proapoptotic effects). The aim of this phase I study is to establish safety, toxicity and maximal tolerable dose of a single infusion of claudiximab in patients suffering from relapsing, advanced gastroesophageal and gastric adenocarcinoma
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 |
|---|---|---|---|
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Claudiximab | Drug | Zolbetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Claudiximab
- interventionNames
- Drug: Claudiximab
Primary outcomes (1)
- measure
- Determination of maximum tolerated dose of claudiximab (Phase I: toxicities as assessed by NCI CTCAE version 3.0)
- timeFrame
- Four weeks
Secondary outcomes (5)
- measure
- Determination of the safety profile
- timeFrame
- Four weeks
- measure
- Pharmacokinetic evaluation
- timeFrame
- Four weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic, refractory or recurrent disease of advanced gastroesophageal cancer (adenocarcinoma) proven by histology * CLDN18.2 expression confirmed by immunohistochemistry * Prior standard chemotherapy containing a fluoropyrimidine, a platinum compound and/or epirubicine, and - if clinically appropriate - docetaxel * At least 1 measurable site of the disease according RECIST criteria (CT-scans or MRT not older than 6 weeks before study entry) * Age ≥ 18 years * ECOG performance status (PS) 0-1 or Karnofsky Index 70-100% * Life expectancy \> 3 months * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10 g/dl * INR \< 1.5 * Bilirubin normal * AST and ALT \< 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * Creatinine \< 1.5 x ULN Exclusion Criteria: * Pregnancy or breastfeeding * Prior allergic reaction or intolerance to a monoclonal antibody * Prior inclusion in the present study * Less than 3 weeks since prior anti-tumor or radiation therapy * Other investigational agents or devices concurrently or within 4 weeks prior to this study * Other concurrent anticancer therapies * History of positive test for human immunodeficiency virus (HIV) antibody * Known Hepatitis. * Uncontrolled or severe illness. * Concurrent administration of anticoagulation agents with vitamin K antagonists * Concurrent administration of therapeutic doses of heparin (prophylactic doses are acceptable)
References
Publications (1)
- DERIVEDSahin U, Schuler M, Richly H, Bauer S, Krilova A, Dechow T, Jerling M, Utsch M, Rohde C, Dhaene K, Huber C, Tureci O. A phase I dose-escalation study of IMAB362 (Zolbetuximab) in patients with advanced gastric and gastro-oesophageal junction cancer. Eur J Cancer. 2018 Sep;100:17-26. doi: 10.1016/j.ejca.2018.05.007. Epub 2018 Jun 21. PMID 29936063