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NCT06364696 · ClinicalTrials.gov registry record · Phase 1
A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Astellas Pharma.
- Active
- Registry status
- Phase 1
- Development phase
- 175
- Enrollment target
- 7
- Study locations
NCT06364696: Active Phase 1 study of Solid Tumor, sponsored by Astellas Pharma.
NCT06364696 is a Phase 1 study of Solid Tumor that is active but no longer recruiting, run by Astellas Pharma. The registered enrollment target is 175 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (21% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06364696, a Phase 1 study of Solid Tumor, is active but no longer recruiting, sponsored by Astellas Pharma.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 175 participants
- Enrollment target
- 7
- Study locations
Study Summary
Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS gene is common in people with some solid tumors. ASP4396 is being developed as a potential new treatment for solid tumors in people who have the G12D mutation in their KRAS gene. ASP4396 is not currently available as a treatment for the public. In this study, researchers will learn how ASP4396 is processed by and acts upon the body. This information will help find a suitable dose and to check for potential medical problems from ASP4396. In this study, ASP4396 is being given to humans for the first time. People in this study will be adults with locally advanced (unresectable), or metastatic solid tumors with the G12D mutation in their KRAS gene. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They may have been previously treated with standard therapies or refused to receive those treatments. The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP4396. This study will be in 2 parts. Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or un
Primary Outcome
A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 at least possibly related to study intervention.
Conditions Studied
Interventions
- DRUG ASP4396
Study Locations (7)
New York
- Icahn School of Medicine at Mount Sinai - New York
- University of Rochester - Rochester
Kansas
- University of Kansas Cancer Center - Westwood
Michigan
- START Midwest - Grand Rapids
Texas
- NEXT Oncology Dallas - Irving
Utah
- START Mountain Region - West Valley City
Virginia
- NEXT Oncology Virginia - Fairfax
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2024-04-16 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What the registry record for NCT06364696 still lists
NCT06364696 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (21% lower).
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which ASP4396 is the first listed.
NCT06364696 lists 7 locations in 6 states (New York, Kansas, Michigan).
Frequently Asked Questions
What is clinical trial NCT06364696 about?
NCT06364696 is a clinical study titled "A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors". Genes contain genetic code which tell the body which proteins to make. Some types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. The so-called G12D mutation in the KRAS g...
What is the current status of trial NCT06364696?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 175 participants. The study started on 2024-04-16. Estimated completion is 2027-04-30.
What conditions does trial NCT06364696 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT06364696?
The interventions under investigation include: ASP4396 (DRUG).
Who is sponsoring clinical trial NCT06364696?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06364696 being conducted?
This trial has 7 study locations across Kansas, Michigan, New York, Texas, Utah. 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 NCT06364696's enrollment target sits among peer trials
175 49th of 196 higher than 148 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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