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A Phase 1 Study of ASP1002 in Participants With Metastatic or Locally Advanced Solid Tumors
The main aims of this study are: * To check the safety of ASP1002 in people with certain solid tumors. * To check if the people can tolerate ASP1002. * To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study. In Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1. People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced). They will have been previously treated with available standard therapies or refused to receive those treatments. In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment. During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished. People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Yale University Cancer Center
New Haven, Connecticut, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Iowa Hospitals
Iowa City, Iowa, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Henry Ford Hospital
Detroit, Michigan, United States
HealthPartners Cancer Research Center
Saint Paul, Minnesota, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Prisma Health-Upstate Cancer Institute
Greenville, South Carolina, United States
Start Date
March 13, 2023
Primary Completion Date
April 30, 2028
Completion Date
May 31, 2028
Last Updated
March 18, 2026
210
ESTIMATED participants
ASP1002
DRUG
Lead Sponsor
Astellas Pharma Global Development, Inc.
NCT06898450
NCT07029399
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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