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A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors
NCT06364696 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06364696
The ClinicalTrials.gov registry entry for NCT06364696 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma, which has 51 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06364696 reports 7 study locations spanning 6 distinct geographic areas — top geographies include New York, Kansas, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06364696?
The interventions under investigation include: ASP4396 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06364696?
This trial is sponsored by Astellas Pharma, which has 51 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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