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NCT05719558 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP1002 in Adults for Treatment of Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 15
- Study locations
NCT05719558 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by Astellas Pharma Global Development. The registered enrollment target is 210 participants, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target. The trial reports 15 study locations across 13 states.
The verdict
NCT05719558, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by Astellas Pharma Global Development.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 15
- Study locations
Study Summary
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 healt
Conditions Studied
Interventions
- DRUG ASP1002
Study Locations (15)
Connecticut
- Yale University Cancer Center - New Haven
- Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut - Plainville
Texas
- University of Texas Southwestern - Dallas
- Mary Crowley Cancer Research Center - Dallas
Florida
- University of Florida - Gainesville
Iowa
- University of Iowa Hospitals - Iowa City
Kentucky
- Norton Cancer Institute - Louisville
Michigan
- Henry Ford Hospital - Detroit
Minnesota
- HealthPartners Cancer Research Center - Saint Paul
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2023-03-13 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05719558
The ClinicalTrials.gov registry entry for NCT05719558 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 197-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which ASP1002 is the first listed.
NCT05719558 reports 15 study locations spanning 13 distinct geographic areas - top geographies include Connecticut, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT05719558 about?
NCT05719558 is a clinical study titled "A Study of ASP1002 in Adults for Treatment of 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 o...
What is the current status of trial NCT05719558?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2023-03-13. Estimated completion is 2028-05-31.
What conditions does trial NCT05719558 study?
This clinical trial studies the following conditions: Advanced Solid Tumors.
What interventions are being tested in trial NCT05719558?
The interventions under investigation include: ASP1002 (DRUG).
Who is sponsoring clinical trial NCT05719558?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05719558 being conducted?
This trial has 15 study locations across Connecticut, Florida, Iowa, Kentucky, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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