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A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma

Primary Purpose

Gastric Neoplasms, Pancreatic Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ASG-5ME
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Neoplasms focused on measuring Monomethyl auristatin E (MMAE), Immunotherapy, AGS-5 Antigen, SLC44A4 Antigen, Gastric Neoplasms, Pancreatic Neoplasms, Antibody-Drug Conjugate, Antibodies, Monoclonal, Drug Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma
  • Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis)
  • ECOG performance status of 0 or 1
  • May be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. For patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab).

Exclusion Criteria:

  • Evidence or history of central nervous system metastases
  • History of another primary malignancy that has not been in remission for at least 3 years
  • Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class III-IV within 6 months prior

Sites / Locations

  • TGen Clinical Research Service at Scottsdale Healthcare
  • University of California at San Francisco
  • University of Chicago
  • Dana-Farber Cancer Institute
  • Texas Oncology - Baylor Sammons Cancer Center
  • Texas Oncology - Tyler
  • Seattle Cancer Care Alliance / University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

ASG-5ME

Outcomes

Primary Outcome Measures

Incidence of adverse events and laboratory abnormalities

Secondary Outcome Measures

Best clinical response
Overall and progression-free survival
Concentrations of ASG-5ME and metabolites in blood
Incidence of antitherapeutic antibodies in blood

Full Information

First Posted
July 19, 2010
Last Updated
August 23, 2013
Sponsor
Seagen Inc.
Collaborators
Agensys, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01166490
Brief Title
A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma
Official Title
A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Agensys, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety and tolerability of ASG-5ME and identify the maximum tolerated dose in patients with pathologically confirmed metastatic pancreatic adenocarcinoma, and to evaluate safety and tolerability in patients with relapsed or refractory gastric adenocarcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Neoplasms, Pancreatic Neoplasms
Keywords
Monomethyl auristatin E (MMAE), Immunotherapy, AGS-5 Antigen, SLC44A4 Antigen, Gastric Neoplasms, Pancreatic Neoplasms, Antibody-Drug Conjugate, Antibodies, Monoclonal, Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ASG-5ME
Intervention Type
Drug
Intervention Name(s)
ASG-5ME
Intervention Description
0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
Primary Outcome Measure Information:
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
Through 1 month after last dose
Secondary Outcome Measure Information:
Title
Best clinical response
Time Frame
Every 2 months
Title
Overall and progression-free survival
Time Frame
Every month until death or study closure
Title
Concentrations of ASG-5ME and metabolites in blood
Time Frame
Through 1 month after last dose
Title
Incidence of antitherapeutic antibodies in blood
Time Frame
Through 1 month after last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically confirmed metastatic pancreatic adenocarcinoma or pathologically confirmed AGS-5-positive gastric or gastric esophageal junction adenocarcinoma Measurable disease (at least one nonresectable, non-nodal lesion greater than or equal to 10 mm in longest diameter or nodal lesion greater than or equal to 15 mm in shortest axis) ECOG performance status of 0 or 1 May be untreated or have previously received treatment for pancreatic adenocarcinoma or must have relapsed or refractory disease following 1 prior systemic therapy for metastatic gastric adenocarcinoma. For patients who have previously received treatment, it must be at least 2 weeks since the last systemic therapy or radiation, and at least 4 weeks since treatment with any monoclonal antibody (other than bevacizumab). Exclusion Criteria: Evidence or history of central nervous system metastases History of another primary malignancy that has not been in remission for at least 3 years Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with NYHA Class III-IV within 6 months prior
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Whiting, PharmD, BCOP
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
TGen Clinical Research Service at Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Texas Oncology - Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Seattle Cancer Care Alliance / University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Dose Escalation Trial of ASG-5ME in Pancreatic or Gastric Adenocarcinoma

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