Clinical trial · Interventional
Dose-ranging Study to Evaluate Antibody Response to G17DT in Patients With Gastric Cancer
An Open, Dose-ranging, Multicenter Study to Determine the Antibody Response to G17DT and Its Safety and Tolerability in the Treatment of Patients With Gastric Cancer
NCT02521649CI-TRIAL-00018840completedPhase 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)
An open, dose-ranging, multiple dose, multi-centre study in patients with Stage I-III or Stage IV gastric cancer. Twelve patients in each of 5 treatment groups were to receive three injections at weeks 0, 2 and 6 with provision for a single booster injection in an extension study period.
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 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 10µg, Stage I-III
- description
- 10µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
- interventionNames
- Drug: G17DT
- type
- EXPERIMENTAL
- label
- 100µg, Stage I-III
- description
- 100µg/0.2 mL dose of G17DT administered at Weeks 0,2, and 6 with an option of a 125µg/0.1 mL dose of G17DT administered at Week 12 based on measured antibody titer.
- interventionNames
- Drug: G17DT
- type
- EXPERIMENTAL
- label
- 250µg, Stage I-III
- description
Eligibility
Eligibility (as posted)
Show eligibility criteria text
Inclusion Criteria: Stage I-III Criteria- * Patients aged 18 years or over who had had a macroscopically curative resection for gastric adenocarcinoma. * Absence of metastatic disease evident from: * physical examination * the most recent chest X-ray * abdominal CT or ultrasound scan * Life expectancy of at least 3 months * WHO performance status of 0 to 1 * Written informed consent given Stage IV Criteria- * Patients aged 18 years or over with Stage IV gastric cancer: carcinoma with the primary tumour invading the adjacent structures and/or involvement of more than 15 regional lymph nodes and/or distant metastases * Life expectancy of at least 3 months * WHO performance status of 0 to 2 * Written informed consent given Exclusion Criteria: * History of other malignant disease except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix Recurrent gastric cancer following previous surgery Presence of metastatic disease: peritoneal deposits or involved lymph nodes outside the limit of resection * Previous use, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies * Concomitant use of immunosuppressants, including systemic (ie oral or injected) corticosteroids * Females who were pregnant, planning to become pregnant or lactating * Patients who were taking part in another study involving an investigational or licensed drug or device in the three months preceding enrolment or during this study * Previous G17DT treatment * Haematological indicators: * Haemoglobin \<10.0g/dl * White blood cell count \<4.0 x 109/l * Platelets \<100 x 109/l
References
Publications (0)
Data not yet available
No reference posted for this study.