Clinical trial · Interventional
A Study to Investigate the Effects of AZD0901 Monotherapy in Adult Participants With 2L+ Advanced or Metastatic Gastric or GEJ Adenocarcinoma Expressing CLDN18.2
A Phase II, Multicentre, Open-label, Single-arm Study of AZD0901 Monotherapy in Second-or Later-Lines Adult Participants With Advanced/Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2
NCT07143604CI-TRIAL-00115086GAMBITactive not recruitingPhase 2ClinicalTrials.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)
The purpose of this study is to measure the efficacy and safety of AZD0901 monotherapy as 2L+ treatment for participants with advanced or metastatic gastric or GEJ adenocarcinoma expressing CLDN18.2.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Cancer | Gastric Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD0901 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AZD0901
- description
- Participants will receive AZD0901 IV, Q3W
- interventionNames
- Drug: AZD0901
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- At month 6 after date of first dose
- description
- ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by the investigator per RECIST 1.1 to all dosed participants
Secondary outcomes (6)
- measure
- Progression Free Survival (PFS)
- timeFrame
- From the date of assignment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 30 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus, with positive CLDN18.2 expression. * Disease progression on or after at least one prior regimen for advanced or metastatic disease, which included a fluoropyrimidine and a platinum, for advanced or metastatic disease. * Must have at least one measurable lesion assessed by the Investigator based on RECIST 1.1. * ECOG performance status of 0 or 1. * Minimum life expectancy of ≥12 weeks. * Adequate organ and bone marrow function. * Minimum body weight of 40 kg. * Sex and Contraceptive Requirements. Exclusion Criteria: * Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH +. * Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers. * CNS metastases or CNS pathology. * Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations). * Persistent toxicities (CTCAE Grade ≥2) caused by previous anticancer therapy. * History of thromboembolic events.
References
Publications (0)
Data not yet available
No reference posted for this study.