Clinical trial · Interventional
AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
A Phase I Investigation of the Intravenous Administration of AGS-1C4D4 in Patients With Advanced Hormone Refractory Prostate Cancer
NCT00519233CI-TRIAL-00014403completedPhase 1ClinicalTrials.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 present study will investigate the safety, tolerability and spectrum of side effects of AGS-1C4D4. As such, this study will characterize the dose limiting toxicities (DLT) and potentially the maximum tolerated dose (MTD) of AGS-1C4D4 in patients with advanced HRPC.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGS-1C4D4 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1.AGS-1C4D4
- interventionNames
- Drug: AGS-1C4D4
Primary outcomes (1)
- measure
- Safety, tolerability and side effects of AGS-1C4D4 in adult patients with advanced HRPC.
- timeFrame
- 3 Months
Secondary outcomes (1)
- measure
- The pharmacokinetic profile of AGS-1C4D4 in adult patients with advanced HRPC.
- timeFrame
- 3 Months
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has hormone-refractory metastatic prostate cancer Exclusion Criteria: * Patient has had chemotherapy, radiotherapy, or biological therapy within the past 4 weeks or has not recovered from side effects * Patient is currently participating or has participated in an investigational study within the past 30 days * Patient has illness or circumstance that could limit compliance with the study requirements * Patient uses illicit drugs or had a recent history of drug or alcohol abuse within the last year * Patient has Hepatitis B or C
References
Publications (1)
- BACKGROUNDAntonarakis ES, Carducci MA, Eisenberger MA, Denmeade SR, Slovin SF, Jelaca-Maxwell K, Vincent ME, Scher HI, Morris MJ. Phase I rapid dose-escalation study of AGS-1C4D4, a human anti-PSCA (prostate stem cell antigen) monoclonal antibody, in patients with castration-resistant prostate cancer: a PCCTC trial. Cancer Chemother Pharmacol. 2012 Mar;69(3):763-71. doi: 10.1007/s00280-011-1759-9. Epub 2011 Oct 22. PMID 22020316