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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01608711

Enrollment

Registered

2012-05-31

Start date

2012-08-07

Completion date

2015-11-16

Last updated

2017-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Pancreatic Ductal, Pancreatic Cancer, Pancreatic Disease

Keywords

Gemcitabine, ASP6182, AGS-1C4D4, Pancreatic Cancer

Brief summary

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.

Detailed description

Subjects will receive a maintenance dose of AGS-1C4D4 every 3 weeks (Q3W) in addition to the gemcitabine administration. If subjects have grade 4 adverse events considered to be related to AGS-1C4D4 at anytime during the study, AGS-1C4D4 treatment will be discontinued for that subject. Subjects will continue to have their tumor status assessed by computerized tomography (CT) and magnetic resonance (MRI) scans according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) guidelines every eight weeks (Q8W). Subjects without evidence of disease progression will continue to receive AGS-1C4D4 and gemcitabine until intolerability, disease progression or consent withdrawal. Subjects who discontinue AGS-1C4D4 for any reason will undergo an end of study visit 4 weeks after their last AGS-1C4D4 infusion.

Interventions

BIOLOGICALAGS-1C4D4

Intravenous Infusion

BIOLOGICALgemcitabine

Intravenous Infusion

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of adverse events	31 months	Grade 3 and 4 adverse events, treatment-related adverse events, serious adverse events and adverse events requiring discontinuation of AGS-1C4D4
Incidence of anti-AGS-1C4D4 antibody formation	Every 8 weeks (up to 31 months)	—

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026