Clinical trial · Interventional
A Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
An Open-Label Phase 2 Study of AGS-1C4D4 in Pancreatic Cancer Subjects Previously Treated in Protocol 2008002
NCT01608711CI-TRIAL-00027576completedPhase 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 continue the safety and immunogenicity of AGS-1C4D4 administered in combination with gemcitabine in subjects previously treated in protocol 2008002.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Pancreatic Ductal | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGS-1C4D4 | Biological | — | UNRESOLVED |
| gemcitabine | Biological | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AGS-1C4D4 plus gemcitabine
- description
- Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration.
- interventionNames
- Biological: AGS-1C4D4
- Biological: gemcitabine
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- 31 months
- description
- Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
- measure
- Incidence of anti-AGS-1C4D4 antibody formation
- timeFrame
- Every 8 weeks (up to 31 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject has stable disease or better per Response Evaluation Criteria in Solid Tumors (RECIST) criteria v.1.1. in Protocol 2008002 Exclusion Criteria: * More than 6 weeks (2 doses) has lapsed from the time of the last infusion in AGS-1C4D4 Protocol 2008002 * Use of the following prohibited medications / therapies: * Monoclonal antibody therapy, other than AGS-1C4D4 * Chemotherapy, other than gemcitabine * Investigational therapy other than AGS-1C4D4 * Erlotinib (Tarceva) * Any clinical condition which would not allow safe conduct of this study
References
Publications (0)
Data not yet available
No reference posted for this study.