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NCT05083481 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Astellas Pharma Global Development.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 366
- Enrollment target
- 20
- Study locations
NCT05083481 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 366 participants, above the 196-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (87% higher). The trial reports 20 study locations across 16 states.
The verdict
NCT05083481, 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
- 366 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 366 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 196-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (87% higher). 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 5 interventions - of which Bevacizumab is the first listed.
NCT05083481 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Kentucky, Tennessee.
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.
What interventions are being tested in trial NCT05083481?
The interventions under investigation include: Bevacizumab (DRUG), ASP1570 (DRUG), pembrolizumab (DRUG), Trifluridine + Tipiracil (DRUG), Docetaxel (DRUG).
Who is sponsoring clinical trial NCT05083481?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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