A Study of ASP3082 in Adults With Advanced Solid Tumors
Public ClinicalTrials.gov record NCT05382559. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05382559
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 681 participants
Conditions and interventions
Conditions
Interventions
- Setidegrasib Drug
- Cetuximab Drug
- Leucovorin Drug
- Oxaliplatin Drug
- Fluorouracil Drug
- Irinotecan Drug
- Nanoparticle albumin-bound-paclitaxel Drug
- Gemcitabine Drug
- Docetaxel Drug
- Pembrolizumab Drug
- Cisplatin Drug
- Carboplatin Drug
- Pemetrexed Drug
- Liposomal Irinotecan Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 7, 2022
- Primary completion
- Dec 30, 2028
- Completion
- Dec 30, 2028
- Last update posted
- Jul 30, 2026
2022 – 2028
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010 | Recruiting |
| UCLA Santa Monica Hematology Oncology | Santa Monica | California | 90404 | Recruiting |
| Denver HealthONE Drug Development Unit | Denver | Colorado | 80218 | Recruiting |
| Smilow Cancer Center at Yale New Haven Hospital | New Haven | Connecticut | 06520-8028 | Recruiting |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Recruiting |
| University of Florida, Davis Cancer Center | Gainesville | Florida | 32610 | Recruiting |
| Florida Cancer Specialist | Lake Mary | Florida | 32746 | Recruiting |
| Florida Cancer Specialists & Research Institute Sarasota | Sarasota | Florida | 34232-6422 | Recruiting |
| University of Kansas Medical Center | Westwood | Kansas | 66205 | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Trinity Health Ann Arbor Hospital | Ypsilanti | Michigan | 48197 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | Recruiting |
| Columbia University - Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | Recruiting |
| University of Rochester Medical Center James P. Wilmot Cancer Center | Rochester | New York | 14642 | Recruiting |
| Case Western | Cleveland | Ohio | 44106 | Recruiting |
| Taylor Cancer Research Center | Maumee | Ohio | 43537 | Recruiting |
| Oregon Health and Science University | Portland | Oregon | 97239 | Recruiting |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Terminated |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| NEXT Oncology | San Antonio | Texas | 78229 | Recruiting |
| NEXT Oncology - Virginia Cancer Specialists | Fairfax | Virginia | 22031 | Recruiting |
| University of Wisconsin Hospital | Madison | Wisconsin | 53792 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05382559, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05382559 live on ClinicalTrials.gov.