NCT01409135

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2011

Typical duration for phase_1

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 11, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 4, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2015

Completed
Last Updated

March 12, 2024

Status Verified

February 1, 2024

Enrollment Period

3.8 years

First QC Date

July 29, 2011

Last Update Submit

March 11, 2024

Conditions

TumorsMedical OncologyNeoplasms

Keywords

Nectin 4 protein, humansCancerPharmacokinetics of AGS-22M6EPharmacokinetics of ASG-22CESafetyClinical Trial, Phase 1ASG-22MEAGS-22M6EASG-22CEASG-22C3

Outcome Measures

Primary Outcomes (2)

  • Incidence of adverse events

    Up to 28 days after the last dose of study drug

  • Composite of Pharmacokinetics: Ceoi or Cmax, Ctrough, Tmax, AUC0-21, t½, CL, Vss

    Concentration at the end of infusion (Ceoi) or Cmax, trough concentration (Ctrough), Tmax, partial AUC after first dose (AUC0-21), terminal or apparent terminal half-life (t1/2), systemic clearance (CL), volume of distribution at steady state (Vss)

    Up to 28 days after the last dose of study drug

Secondary Outcomes (3)

  • Incidence of anti-drug antibody formation

    Up to 28 days after the last dose of study drug

  • Objective tumor response rate

    Every 8 weeks (± 14 days)

  • Disease Control Rate

    Every 8 weeks (± 14 days)

Study Arms (9)

AGS-22M6E-11-1 Dose Level 1

EXPERIMENTAL
Drug: AGS-22M6E

AGS-22M6E-11-1 Dose Level 2

EXPERIMENTAL
Drug: AGS-22M6E

AGS-22M6E-11-1 Dose Level 3

EXPERIMENTAL
Drug: AGS-22M6E

AGS-22M6E-11-1 Dose Level 4

EXPERIMENTAL
Drug: AGS-22M6E

AGS-22M6E-11-1 Dose Level 5

EXPERIMENTAL
Drug: AGS-22M6E

AGS-22M6E-11-1 Dose Level 6

EXPERIMENTAL
Drug: AGS-22M6E

ASG-22CE Expansion Cohort 1

EXPERIMENTAL

Breast Cancer

Drug: ASG-22CE

ASG-22CE Expansion Cohort 2

EXPERIMENTAL

Bladder Cancer

Drug: ASG-22CE

ASG-22CE Expansion Cohort 3

EXPERIMENTAL

Lung plus other solid tumor cancers

Drug: ASG-22CE

Interventions

AGS-22M6EDRUG

IV Infusion

AGS-22M6E-11-1 Dose Level 1AGS-22M6E-11-1 Dose Level 2AGS-22M6E-11-1 Dose Level 3AGS-22M6E-11-1 Dose Level 4AGS-22M6E-11-1 Dose Level 5AGS-22M6E-11-1 Dose Level 6
ASG-22CEDRUG

IV Infusion

ASG-22CE Expansion Cohort 1ASG-22CE Expansion Cohort 2ASG-22CE Expansion Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have a tumor positive for Nectin-4 expression (as measured by central laboratory using primary or metastatic tumor tissue
  • Histologically confirmed malignant solid tumors (excluding sarcoma) that have failed all FDA approved therapies indicated for the type of metastatic cancer and line of therapy or for which they were not a candidate to receive treatment
  • Measurable disease according to RECIST criteria (version 1.1) (Eisenhauer, et. al.) defined as tumor lesions that are accurately measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) with a minimum size of:
  • mm by CT scan (CT scan slice thickness no greater than 5mm
  • mm caliper measurement by clinical exam (lesions which cannot be accurately measured with calipers should be recorded as nonmeasurable
  • mm by chest X-ray
  • ≥ 15 mm in short axis for lymph nodes when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm)
  • Note: bone lesions, ascites, and pleural effusions are not considered measurable lesions
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Negative pregnancy test (women of childbearing potential)
  • Hematologic function, as follows:
  • a. Absolute neutrophil count (ANC) ≥ 1.0 x109 /L
  • b. Platelet count ≥ 100 x 109/L
  • c. Hemoglobin ≥ 8.5 g/dL
  • Renal function, as follows: serum creatinine ≤ 2.0 mg/dL, or measured 24 hour creatinine clearance of ≥ 45 mL/min
  • +13 more criteria

You may not qualify if:

  • Preexisting neuropathy Grade ≥ 3 or motor neuropathy Grade ≥ 2
  • Uncontrolled brain or epidural spinal metastases
  • Use of any investigational drug within 14 days or 5 half-lives prior to first dose of study drug
  • Any anticancer therapy including: small molecules, immunotherapy, chemotherapy, monoclonal antibody therapy, radiotherapy or any other agents to treat cancer within 28 days prior to first dose of study drug
  • Active angina or Class III or IV Congestive Heart Failure (New York Heart Association CHF Functional Classification System) or clinically significant cardiac disease within 12 months of the first dose of study drug, including myocardial infarction, unstable angina, grade 2 or greater peripheral vascular disease, congestive heart failure, uncontrolled hypertension, or arrhythmias not controlled by medication
  • Known HIV or AIDS
  • Decompensated liver disease as evidenced by clinically significant ascites refractory to diuretic therapy, hepatic encephalopathy, or coagulopathy
  • History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,deep vein thrombosis ( DVT) or pulmonary embolism ( PE)) prior to first dose of study drug
  • Major surgery within 28 days prior to first dose of study drug
  • Active infection requiring treatment ≤7 days prior to first dose of study drug
  • Anti-androgen therapy initiated within 28 days of enrollment (for prostate cancer patients only)
  • Positive Hepatitis B surface antigen test
  • Positive Hepatitis C antibody test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

University of Colorado, Denver-Aurora

Aurora, Colorado, 80045, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Karmanos Cancer institute

Detroit, Michigan, 48201, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

Related Links

MeSH Terms

Conditions

Neoplasms

Interventions

enfortumab vedotin

Study Officials

  • Medical Monitor

    Agensys, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 4, 2011

Study Start

July 11, 2011

Primary Completion

April 27, 2015

Study Completion

April 27, 2015

Last Updated

March 12, 2024

Record last verified: 2024-02

Locations

CA(1)US(8)