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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Open-Label, Dose Escalation Study of ASG-5ME in Patients With Pancreatic or Gastric Adenocarcinoma

Conditions
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Gastric Neoplasms, Pancreatic Neoplasms

Intervention / Treatment
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* Drug: ASG-5ME


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>ASG-5ME | Drug: ASG-5ME<br>* 0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and laboratory abnormalities |  | Through 1 month after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best clinical response |  | Every 2 months | 
| Overall and progression-free survival |  | Every month until death or study closure | 
| Concentrations of ASG-5ME and metabolites in blood |  | Through 1 month after last dose | 
| Incidence of antitherapeutic antibodies in blood |  | Through 1 month after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Monomethyl auristatin E (MMAE), Immunotherapy, AGS-5 Antigen, SLC44A4 Antigen, Gastric Neoplasms, Pancreatic Neoplasms, Antibody-Drug Conjugate, Antibodies, Monoclonal, Drug Therapy