Clinical trial · Interventional
Study to Assess Tolerability and Safety and Antibody Response to G17DT in Gastric Cancer Patients
An Open, Multi-centre Study to Determine the Tolerability, Safety and Antibody Response Resulting From G17DT at 250mcg at Weeks 0, 2 and 6 With a Booster of 125mcg or 250mcg Given to Patients With Stage I - III Gastric Cancer
- 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)
Open-label, multicenter study to assess 250µg/0.2ml G17DT injection at weeks 0, 2 and 6. At or after week 20 and up to and including week 44. Subjects who raised antibodies to G17DT were given an additional dose of 125µg/0.1ml or 250µg/0.2ml G17DT between weeks 20-44 (study duration 52 weeks).
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| G17DT | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 250µg dose treatment
- description
- Subjects were treated with a 250mcg/0.2ml G17DT injection at weeks 0, 2 and 6.
- interventionNames
- Biological: G17DT
Primary outcomes (1)
- measure
- Measurable Gastrin-17 Antibody Titer
- timeFrame
- Up to Week 52
Secondary outcomes (2)
- measure
- Injection tolerability
- timeFrame
- Up to Week 52
- description
- Subjects were monitored for injection site reactions and/or swelling at the injections site.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who had had curative resection for histologically confirmed Stage I, II, or III gastric carcinoma or carcinoma of the oesophagogastric junciton. * Male or female patients over 18 years of age. * Patients with a life expectancy of at least four months. * Karnofsky index for performance status of \>70% * Patients must have given written informed consent. Exclusion Criteria: * Gastric or junctional surgery within three weeks of baseline (week 0) or gastric or junctional surgery anticipated in the study period. * History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix. * Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of chemotherapy or immunotherapy. * Previous use (within the six weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of radiotherapy or any other anti-cancer therapy. * Previous use (within the four weeks prior to the screening visit of the study), concomitant use, or anticipated use (up to week 16), of immunosuppressants, including systemic corticosteroids. * Known immunodeficiency. * Females who were pregnant, planning to become pregnant or lactating. Women, who in the opinion of the investigator were of child bearing potential, were to have a negative pregnancy test before study drug administration. * Patients taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or up to week 16 during this study. * Previous G17DT treatment. * Haematological indicators: Haemoglobin \<10.0g/dl Neutrophils \< 2.0 x 109/l Platelets \<100 x 109/l
References
Publications (0)
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