Clinical trial NCT01166490: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Agensys, Inc.
First posted: 2010-07-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: Through 1 month after last dose
Secondary outcomes:
measure: Best clinical response
timeFrame: Every 2 months
measure: Overall and progression-free survival
timeFrame: Every month until death or study closure
measure: Concentrations of ASG-5ME and metabolites in blood
timeFrame: Through 1 month after last dose
measure: Incidence of antitherapeutic antibodies in blood
timeFrame: Through 1 month after last dose
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: TGen Clinical Research Service at Scottsdale Healthcare
state: Arizona
city: San Francisco
country: United States
facility: University of California at San Francisco
state: California
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Dallas
country: United States
facility: Texas Oncology - Baylor Sammons Cancer Center
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Tyler
state: Texas
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance / University of Washington
state: Washington
Study officials:
affiliation: Seagen Inc.
name: Nancy Whiting, PharmD, BCOP
role: STUDY_DIRECTOR
References: