A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT07488676
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • ASP546C — DRUG
    Intravenous administration

Study Details

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.

Key Dates

Start date
May 4, 2026
Status verified
May 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 - Cohort 1 ASP546C Lower Dose
    Participants with unresectable locally advanced or metastatic (uLA/m) gastroesophageal adenocarcinoma will receive a lower dose of ASP546C intravenously, once every 3 weeks (Q3W).
  • Experimental: Part 1 - Cohort 2 ASP546C Higher Dose
    Participants with uLA/m gastroesophageal adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
  • Experimental: Part 2 - Cohort 3 ASP546C Higher Dose
    Participants with uLA/m pancreatic adenocarcinoma will receive a higher dose of ASP546C intravenously, once Q3W.
  • Experimental: Part 2 - Cohort 4 ASP546C Higher Dose
    Participants with pan-tumor (cholangiocarcinoma, colorectal adenocarcinoma, NSCLC, SCLC, ovarian mucinous carcinoma or invasive breast cancer) will receive a higher dose of ASP546C intravenously, once Q3W.

Primary Outcome Measure

Part 1: Objective Response Rate (ORR) per Investigator-assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 36 Months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
START Los AngelesLos AngelesCalifornia90025-
START MidwestGrand RapidsMichigan49546-
START New YorkLake SuccessNew York10042-
Duke Cancer Center DurhamDurhamNorth Carolina27710-
Next Oncology - AustinAustinTexas78758-
Next Oncology - HoustonHoustonTexas77054-
Next Oncology - DallasIrvingTexas75039-
START San AntonioSan AntonioTexas78229-
START Mountain RegionWest Valley CityUtah84119-

Find similar trials in Los Angeles, CA

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
START Los Angeles· Los Angeles, CASTART Midwest· Grand Rapids, MISTART New York· Lake Success, NYDuke Cancer Center Durham· Durham, NCNext Oncology - Austin· Austin, TXNext Oncology - Houston· Houston, TX

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