A Study of ASP3082 in Adults With Advanced Solid Tumors (NCT05382559)
A Phase 1 Study of ASP3082 in Participants With Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: City of Hope National Medical Center — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (66 Sites)
Showing the first 25 of 66 sites.
- City of Hope National Medical Center — Duarte, California
- UCLA Santa Monica Hematology Oncology — Santa Monica, California
- Denver HealthONE Drug Development Unit — Denver, Colorado
- Smilow Cancer Center at Yale New Haven Hospital — New Haven, Connecticut
- Georgetown University Hospital — Washington D.C., District of Columbia
- University of Florida, Davis Cancer Center — Gainesville, Florida
- Florida Cancer Specialist — Lake Mary, Florida
- Florida Cancer Specialists & Research Institute Sarasota — Sarasota, Florida
- University of Kansas Medical Center — Westwood, Kansas
- Beth Israel Deaconess Medical Center — Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts
- Trinity Health Ann Arbor Hospital — Ypsilanti, Michigan
- Washington University School of Medicine — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- Roswell Park Cancer Institute — Buffalo, New York
- Columbia University - Herbert Irving Comprehensive Cancer Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester Medical Center James P. Wilmot Cancer Center — Rochester, New York
- Case Western — Cleveland, Ohio
- Taylor Cancer Research Center — Maumee, Ohio
- Oregon Health and Science University — Portland, Oregon
- SCRI Oncology Partners — Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee
- NEXT Oncology — San Antonio, Texas
- NEXT Oncology - Virginia Cancer Specialists — Fairfax, Virginia
📞 Contact the Study Coordinator
Phone: (800) 888-7704
Email: astellas.registration@astellas.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.