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NCT05382559 · ClinicalTrials.gov registry record · Phase 1
A Study of ASP3082 in Adults With Advanced Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Astellas Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 681
- Enrollment target
- 20
- Study locations
NCT05382559: Recruiting Phase 1 study of Solid Tumor, sponsored by Astellas Pharma.
NCT05382559 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Astellas Pharma. The registered enrollment target is 681 participants, above the 218-participant average among 196 other Solid Tumor trials with a reported enrollment target (212% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05382559, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Astellas Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 681 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082 by itself, or together with cetuximab. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082, by itself or together with cetuximab, to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have received ASP3082 (by itself or together with cetuximab) or until suitable doses have been selected for Part 2. In Part 2, ASP3082 will be given in by itself, or in combination with the other study treatments. Study treatments will be given through a vein. This is called an infusion. Each treatment cycle is 21 or 28 days long. They will continue treatment until: they have medical problems from the treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
Primary Outcome
A DLT is defined as any event meeting the DLT criteria excluding toxicities clearly related to disease progression or intercurrent illness or standard of care (SoC) regimens as determined by the investigator.
Conditions Studied
Interventions
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Cetuximab
- DRUG Setidegrasib
Study Locations (20)
Florida
- University of Florida, Davis Cancer Center - Gainesville
- Florida Cancer Specialist - Lake Mary
- Florida Cancer Specialists & Research Institute Sarasota - Sarasota
New York
- Roswell Park Cancer Institute - Buffalo
- Columbia University - Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering Cancer Center - New York
California
- City of Hope National Medical Center - Duarte
- UCLA Santa Monica Hematology Oncology - Santa Monica
Massachusetts
- Beth Israel Deaconess Medical Center - Boston
- Dana Farber Cancer Institute - Boston
Tennessee
- SCRI Oncology Partners - Nashville
- Vanderbilt University Medical Center - Nashville
Colorado
- Denver HealthONE Drug Development Unit - Denver
Connecticut
- Smilow Cancer Center at Yale New Haven Hospital - New Haven
District of Columbia
- Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 681 participants |
| Start Date | 2022-06-08 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT05382559 shows while recruiting
NCT05382559 is an interventional study that assigns participants to a tested intervention. The registered 681 participants enrollment target is mid-sized for trials with a published cap, above the 218-participant average among 196 other Solid Tumor trials with a reported enrollment target (212% higher).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 5 interventions - of which Fluorouracil is the first listed.
NCT05382559 names 20 study sites across 13 states, led by Florida, New York, California.
Frequently Asked Questions
What is clinical trial NCT05382559 about?
NCT05382559 is a clinical study titled "A Study of ASP3082 in Adults With Advanced Solid Tumors". This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082. The study aims to check how safe and well-tolerated ASP3082 is for people with advanced solid tumors that have a specific mutation called KRAS G12D. This study will be in 2...
What is the current status of trial NCT05382559?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 681 participants. The study started on 2022-06-08. Estimated completion is 2027-12-31.
What conditions does trial NCT05382559 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT05382559?
The interventions under investigation include: Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), Setidegrasib (DRUG).
Who is sponsoring clinical trial NCT05382559?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05382559 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05382559's enrollment target sits among peer trials
681 6th of 196 higher than 191 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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