Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of ASP1002 in Adults for Treatment of Solid Tumors
NCT05719558 · View on ClinicalTrials.gov ↗
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?
Always speak with your doctor before enrolling in a clinical 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 172 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05719558 reports 15 study locations spanning 13 distinct geographic areas — top geographies include Connecticut, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05719558?
The interventions under investigation include: ASP1002 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05719558?
This trial is sponsored by Astellas Pharma Global Development, which has 172 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.