Loading
Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · September 22, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07488676). This is a study registration, not published results. Lead sponsor: Astellas Pharma Global Development, Inc.. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 150 participants (ESTIMATED). Conditions: Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma. Interventions: DRUG: ASP546C. Primary outcome measures: Part 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 , Up to 36 Months; Part 1: Pharmacokinetics (PK) of ASP546C Antibody-drug Conjugate (ADC): Serum Concentrations of Antibody-drug Conjugate , Up to 39 Months; Part 1: PK of ASP546C ADC: Maximum Concentration (Cmax) , Up to 39 Months; Part 1: PK of ASP546C ADC: Area Under the Serum Concentration-time Curve from Time Zero to 21Days (AUC0-21d) , Up to 39 Months; Part 1: Number of participants with Adverse events (AEs) , Up to 39 Months; Part 1: Number of Participants with Vital Sign Abnormalities and/or AEs , Up to 39 Months; Part 1: Number of Participants with Laboratory Value Abnormalities and/or AEs , Up to 39 Months; Part 1: Number of Participants at Each Grade of Eastern Cooperative Oncology Group (ECOG) Performance Status Scores , Up to 39 Months. Brief summary: This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach. This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion. In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C. In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C. People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.