A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07024615
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP2138 — DRUG
    Subcutaneously
  • Oxaliplatin — DRUG
    Injection
  • Leucovorin — DRUG
    Injection
  • 5-FU — DRUG
    Injection
  • Irinotecan — DRUG
    Injection
  • Gemcitabine — DRUG
    Intravenously
  • Nab-paclitaxel — DRUG
    Intravenously
  • Capecitabine — DRUG
    Oral

Study Details

Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell. The T-cell "tells" the immune system to attack the tumor. This study is for people with resectable PDAC. Resectable means that the tumor can be removed by surgery. In this study, adults with resectable PDAC will receive an ASP2138 injection just below the skin (subcutaneous) 2 weeks before surgery. After surgery, they will be given standard chemotherapy treatments chosen by their study doctor. These include mFOLFIRINOX, gemcitabine with nab-paclitaxel, or gemcitabine with capecitabine. People will receive chemotherapy treatment for up to 6 months, or until their cancer gets worse, they cannot tolerate the chemotherapy, or they or their study doctor thinks they should stop chemotherapy. People will have a final clinic visit about a month after finishing chemotherapy for health checks.

Key Dates

Start date
Oct 16, 2025
Status verified
May 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ASP2138 and investigator's choice of adjuvant chemotherapy
    Participants will receive ASP2138 for up to 2 weeks prior to surgery. Following surgery participants will receive adjuvant chemotherapy (either mFOLFIRINOX \[modified leucovorin (folinic acid), 5-FU (fluorouracil), irinotecan and oxaliplatin\], Gemcitabine/Nab-paclitaxel, or Gemcitabine/Capecitabine) for up to 6 months or until meeting treatment discontinuation criteria.

Primary Outcome Measure

Number of participants with Adverse Events (AEs) [ Time Frame: Up to 11.5 months ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Duke University Medical Center - Duke Cancer CenterDurhamNorth Carolina27710-

Find similar trials in Boston, MA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Massachusetts General Hospital· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYDuke University Medical Center - Duke Cancer Center· Durham, NC

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