CLINICAL_TRIALS ClinicalTrials.gov record update

A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression

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Record identity and dates

Source: ClinicalTrials.gov
Source record ID: NCT05365581
Title field or adapter rule: {'original_value': 'A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression', 'source_field': 'protocolSection.identificationModule.officialTitle'}
Ingested At: 2026-10-31T23:27:26.063320+00:00
Published At: 2026-09-11T00:00:00+00:00
Record Updated At: 2026-09-11
Source Retrieved At: 2026-10-31T22:17:56.788771+00:00
Timestamp Basis: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter
Date limitation: ClinicalTrials.gov API/RSS response retrieval timestamp recorded by Dossier adapter

Fields recorded by this source

protocolSection.conditionsModule.conditions: ["Gastric Adenocarcinoma", "Gastroesophageal Junction (GEJ) Adenocarcinoma", "Pancreatic Adenocarcinoma"]
protocolSection.statusModule.lastUpdatePostDateStruct: {"date": "2026-09-11", "type": "ACTUAL"}
protocolSection.identificationModule.nctId: "NCT05365581"
protocolSection.identificationModule.officialTitle: "A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression"
protocolSection.statusModule.overallStatus: "RECRUITING"
protocolSection.designModule.phases: ["PHASE1"]
protocolSection.statusModule.resultsFirstPostDateStruct: null

Study condition terms

Interventions recorded in this study

{'armGroupLabels': ['ASP2138 + Pembrolizumab & CAPOX CTDE Exploratory Cohort (Phase1b) Gastric/GEJ Cancer - Japan & Korea', 'ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer', 'Monotherapy Dose Escalation (Phase 1)', 'Monotherapy Dose Expansion (Phase 1b) Gastric/GEJ cancer', 'Monotherapy Dose Expansion (Phase 1b) Pancreatic cancer'], 'description': 'Intravenously or Subcutaneously', 'name': 'ASP2138', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Pembrolizumab & CAPOX CTDE Exploratory Cohort (Phase1b) Gastric/GEJ Cancer - Japan & Korea', 'ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer'], 'description': 'Intravenously', 'name': 'Pembrolizumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Pembrolizumab & CAPOX CTDE Exploratory Cohort (Phase1b) Gastric/GEJ Cancer - Japan & Korea', 'ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer'], 'description': 'Intravenously', 'name': 'Oxaliplatin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer'], 'description': 'Intravenously', 'name': 'Leucovorin', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Pembrolizumab & mFOLFOX6 Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part G - First-line Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer'], 'description': 'Intravenously', 'name': 'Fluorouracil', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ Cancer'], 'description': 'Intravenously', 'name': 'Ramucirumab', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Ramucirumab & Paclitaxel Combination Therapy Dose Expansion (Phase 1b) Gastric/GEJ Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part H - Second-line Gastric/GEJ Cancer'], 'description': 'Intravenously', 'name': 'Paclitaxel', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + mFOLFIRINOX Combination Therapy Dose Expansion (Phase 1b) Pancreatic Cancer', 'Combination Therapy Dose Escalation (Phase 1) Part I - First line Pancreatic Cancer'], 'description': 'Intravenously', 'name': 'Irinotecan', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])
{'armGroupLabels': ['ASP2138 + Pembrolizumab & CAPOX CTDE Exploratory Cohort (Phase1b) Gastric/GEJ Cancer - Japan & Korea'], 'description': 'Oral Administration', 'name': 'Capecitabine', 'type': 'DRUG'} (protocolSection.armsInterventionsModule.interventions[])

An intervention appearing in a study record does not establish an effect or an approved use.

Drug names recorded in this source

A recorded drug name is not by itself an indication or a condition-specific relationship.

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