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A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects with Malignant Solid Tumors that Express Nectin-4

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT01409135

Astellas Study ID

The unique identification code given by the study sponsor.

AGS-22M6E-11-1

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

Follow Trial

Condition

Advanced/Metastatic Cancer

Phase

These clinical trials are usually the first time an experimental treatment is studied in a small group of people.

Phase 1

Age

18 Years - N/A

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Jun 2011 - Apr 2015

Masking

None (Open Label)

Enrollment number

34

A Phase 1 Study of the Safety and Pharmacokinetics of Escalating Doses of AGS-22M6E or ASG-22CE Given as Monotherapy Followed by Expansion Cohorts in Subjects With Malignant Solid Tumors That Express Nectin-4

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, United States, 94115

University of Colorado, Denver-Aurora

Aurora, United States, 80045

Emory University

Atlanta, United States, 30322

Dana-Farber Cancer Institute

Boston, United States, 02115

Karmanos Cancer institute

Detroit, United States, 48201

Roswell Park Cancer Institute

Buffalo, United States, 14263

Memorial Sloan Kettering Cancer Center

New York, United States, 10021

University of North Carolina, Chapel Hill

Chapel Hill, United States, 27599

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

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