Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01409135 · ClinicalTrials.gov registry record · Phase 1
A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4
A Phase 1 study of Neoplasms and Tumors, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 9
- Study locations
NCT01409135: Completed Phase 1 study of Neoplasms and Tumors, sponsored by Astellas Pharma.
NCT01409135 is a Phase 1 study of Neoplasms and Tumors that has completed, run by Astellas Pharma. The registered enrollment target is 34 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower). The trial reports 9 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01409135, a Phase 1 study of Neoplasms and Tumors, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 9
- Study locations
Study Summary
A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in subjects with malignant solid tumors that express Nectin-4.
Conditions Studied
Interventions
- DRUG AGS-22M6E
- DRUG ASG-22CE
Study Locations (9)
New York
- Roswell Park Cancer Institute - Buffalo
- Memorial Sloan Kettering Cancer Center - New York
California
- UCSF Helen Diller Family Comprehensive Cancer Center - San Francisco
Colorado
- University of Colorado, Denver-Aurora - Aurora
Georgia
- Emory University - Atlanta
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- Karmanos Cancer institute - Detroit
North Carolina
- University of North Carolina, Chapel Hill - Chapel Hill
Alberta
- Cross Cancer Institute - Edmonton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2011-07-11 |
| Est. Completion | 2015-04-27 |
| Phase | Phase 1 |
What the finished NCT01409135 record still lists
NCT01409135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which AGS-22M6E is the first listed.
NCT01409135 lists 9 locations in 8 states (New York, California, Colorado).
Frequently Asked Questions
What is clinical trial NCT01409135 about?
NCT01409135 is a clinical study titled "A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4". A study examining the safety of AGS-22M6E or ASG-22CE administered as monotherapy therapy in subjects with malignant solid tumors that express Nectin-4.
What is the current status of trial NCT01409135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2011-07-11. Estimated completion is 2015-04-27.
What conditions does trial NCT01409135 study?
This clinical trial studies the following conditions: Neoplasms, Tumors, Medical Oncology.
What interventions are being tested in trial NCT01409135?
The interventions under investigation include: AGS-22M6E (DRUG), ASG-22CE (DRUG).
Who is sponsoring clinical trial NCT01409135?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01409135 being conducted?
This trial has 9 study locations across California, Colorado, Georgia, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01409135's enrollment target sits among peer trials
34 127th of 158 higher than 31 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Clinical Activity of RO7673396 in Participants With Advanced Solid Tumors Harboring Rat Sarcoma Viral Oncogene Homolog (RAS) Mutation(s)
RECRUITING · Phase 1
-
A Study of GSK5764227 in Participants With. Advanced Solid Tumors (EMBOLD PanTumor-101)
RECRUITING · Phase 1
-
Adoptive Cell Therapy Long-term Follow-up (LTFU) Study
RECRUITING · Phase 1
-
Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies
RECRUITING · Phase 1
-
EMB-01 in Patients With Advanced/Metastatic Gastrointestinal Cancers
RECRUITING · Phase 1
-
Open-Label Study of Pocenbrodib Alone and in Combination With Abiraterone Acetate, Olaparib, or 177Lu-PSMA-617
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI