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NCT04086758
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects With Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Phase 1 trial testing zolbetuximab in Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma in 12 participants. Completed in 22 January 2021.
22 January 2021
Quick facts
| Lead sponsor | Astellas Pharma China, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 18 October 2019 |
| Primary completion | 22 January 2021 |
| Estimated completion | 22 January 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- zolbetuximab (ZOLBETUXIMAB) — full drug profile →
Conditions studied
- Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma — all drugs for Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma →
Sponsor
Astellas Pharma China, Inc. — full company profile →
Who can join
18 and older, any sex, with Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Pharmacokinetic Study of Zolbetuximab (IMAB362) in Chinese Subjects with Locally Advanced Unresectable or Metastatic Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting CLDN18.2 in cancers of the gastrointestinal tract: New drugs and new indications.
Chen J, Xu Z, Hu C, Zhang S, et al · · 2023 · cited 49× · PMID 36969060 · DOI 10.3389/fonc.2023.1132319
Verify or expand the search:
- PubMed search for NCT04086758
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of zolbetuximab
Trials testing the same drug.
- NCT06962137 — Phase II RAINSPOT: Zolbetuximab-Paclitaxel-Ramucirumab for CLDN18.2 Positive Gastro-esophageal Cancer · Phase 2 · recruiting
- NCT06396091 — A Study of Zolbetuximab With Chemotherapy in Adults With Pancreatic Cancer · Phase 1 · active not recruiting
- NCT06901531 — A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer · Phase 3 · recruiting
- NCT06881017 — Establishment of Precision Targeted Therapy Strategies for Advanced Gastric Cancer Based on Novel Molecular Subtyping · Phase 2 · not yet recruiting
- NCT06732856 — A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locall · Phase 1, PHASE2 · recruiting
Other recruiting trials for Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma
Currently open trials in the same condition.
- NCT07488676 — A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors · Phase 1, PHASE2 · recruiting
Other Astellas Pharma China, Inc. trials
Trials by the same sponsor.
- NCT05152628 — A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo · Phase 4 · completed
- NCT05153915 — A Study to Evaluate the Safety and Efficacy of a Modigraf® Based Immunosuppression Regimen in De Novo Pediatric Allograf · Phase 4 · completed
- NCT04995419 — A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial · Phase 2 · completed
- NCT04793204 — A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects · Phase 1 · completed
- NCT04562090 — A Study With Mirabegron 50 mg and 25 mg in Chinese Participants With Overactive Bladder · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04086758 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma China, Inc.
- Last refreshed: 20 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04086758.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing