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A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
NCT05083481 · View on ClinicalTrials.gov ↗
Study Summary
Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The researchers are finding ways to switch the T-cells back on. Before a treatment can be approved for use, clinical studies need to be done. This study will provide more information on ASP1570 in adults with advanced solid tumors. ASP1570 will either be given by itself, or given with another medicine called pembrolizumab, given with a standard cancer therapy, or given together with pembrolizumab and other medicines called pemetrexed and carboplatin. The main aims of this study are： * To check the safety of ASP1570 * To check how well ASP1570 is tolerated * To find a suitable dose of ASP1570 This study is for adults with advanced solid tumors. Their tumor has either grown outside of the area where it started (locally advanced and unresectable) or it has spread to other parts of the body (metastatic). Their cancer gets worse after standard therapy or they are unable to have standard therapy. The study doctors can give more advice about who can take part. This study will be in 2 parts. In Part 1, the most suitable dose of ASP1570 to give to people with advanced solid tumors will be worked out. Different small groups of people with advanced solid tumors will take lower to higher doses of ASP1570. People will either be given ASP1570 by itself, or ASP1570 with pembrolizumab, ASP1570 with a standard cancer therapy, or ASP1570 with pembrolizumab, pemetrexed and carboplatin. The study treatment given depends on the type of cancer people have. There are different doses of ASP1570, with each group staying on the same dose. There is just 1 standard dose of pembrolizumab. The dose of a standard cancer therapy depends on its label. After taking the lowest dose of ASP1570, the first
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG ASP1570
- DRUG pembrolizumab
- DRUG Trifluridine + Tipiracil
- DRUG Docetaxel
Study Locations (20)
California
- Providence Medical Foundation — Fullerton
- California Research Institute — Los Angeles
- USC/Norris Comprehensive Cancer Center — Los Angeles
Kentucky
- University of Kentucky Medical Center MCC-CRO — Lexington
- Norton Cancer Institute — Louisville
Tennessee
- SCRI Oncology Partners — Nashville
- Vanderbilt Ingram Cancer Center — Nashville
Florida
- Florida Cancer Specialist & Research Institute Sarasota — Sarasota
Illinois
- University of Chicago — Chicago
Maryland
- American Oncology Partners — Bethesda
Nebraska
- Nebraska Methodist Hospital — Omaha
New Jersey
- Atlantic Health System/Morristown Medical Center — Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 366 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2028-05-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05083481
The ClinicalTrials.gov registry entry for NCT05083481 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 366 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 5 interventions — of which Bevacizumab 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: NCT05083481 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Kentucky, Tennessee. 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 NCT05083481 about?
NCT05083481 is a clinical study titled "A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors". Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors. However, some tumors can become resistant to attack by T-cells over time. They do this by sending "off" signals to T-cells. The ...
What is the current status of trial NCT05083481?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 366 participants. The study started on 2021-10-19. Estimated completion is 2028-05-31.
What conditions does trial NCT05083481 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 NCT05083481?
The interventions under investigation include: Bevacizumab (DRUG), ASP1570 (DRUG), pembrolizumab (DRUG), Trifluridine + Tipiracil (DRUG), Docetaxel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05083481?
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 NCT05083481 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kentucky, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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