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A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

Primary:
To evaluate the safety and tolerability of ASP2138
To determine the MTD and/or the RP2D regimen(s) of ASP2138

Secondary:
To evaluate the PK of ASP2138
To evaluate the antitumor activity of ASP2138
To evaluate changes in CLDN18.2 and PD-L1
tumor expression related to treatment with ASP2138

Exploratory:
To evaluate potential genomic and/or other biomarkers that may correlate with treatment outcome of ASP2138
To evaluate the immunogenicity of ASP2138
To evaluate additional PK parameters of ASP2138
To evaluate antitumor activity of ASP2138

Protocol Number: 072305
Phase: Phase I
Applicable Disease Sites: Pancreas
Drugs Involved: ASP2138
Principal Investigator: Howard Hochster
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.