Finding the right dose of ASP4396 for adults with solid tumors
An Open-label Phase 1 Study of ASP4396 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation
PHASE1 · Astellas Pharma Inc · NCT06364696
This study is testing the right dose of a new treatment called ASP4396 for adults with advanced solid tumors that have a specific KRAS gene mutation to see how safe it is and how it works in the body.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 175 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Astellas Pharma Inc (industry) |
| Locations | 7 sites (Westwood, Kansas and 6 other locations) |
| Trial ID | NCT06364696 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and appropriate dosing of ASP4396, a new treatment for adults with locally advanced or metastatic solid tumors that have a specific mutation in the KRAS gene (G12D). Researchers aim to understand how the drug is processed in the body and its effects on patients. Participants must have measurable tumors and have previously undergone standard therapy. This is the first time ASP4396 is being administered to humans.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable or metastatic solid tumors that have the KRAS G12D mutation and have received prior standard therapy.
Not a fit: Patients with untreated symptomatic central nervous system metastases or other active malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with solid tumors harboring the KRAS G12D mutation.
How similar studies have performed: Other studies targeting KRAS mutations have shown promise, but this specific approach with ASP4396 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and has received prior standard therapy. * Participant has at least 1 measurable lesion per RECIST v1.1. * Participant has an ECOG performance status of 0 or 1. * Participant has adequate organ function. Exclusion Criteria: * Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic and treated and stable CNS metastases are eligible. * Participant has leptomeningeal disease as a manifestation of the current malignancy. * Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast, which are allowed. * Participant with active hepatitis B or hepatitis C virus (HCV). * Participant has a known history of human immunodeficiency virus (HIV) infection with acquired immunodeficiency syndrome (AIDS)-related complications. * Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention. * Participant is expected to require another form of anticancer therapy while on study intervention. * Participant has any condition that makes the participant unsuitable for study participation.
Where this trial is running
Westwood, Kansas and 6 other locations
- University of Kansas Cancer Center — Westwood, Kansas, United States (RECRUITING)
- START Midwest — Grand Rapids, Michigan, United States (RECRUITING)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
- University of Rochester — Rochester, New York, United States (RECRUITING)
- NEXT Oncology Dallas — Irving, Texas, United States (RECRUITING)
- START Mountain Region — West Valley City, Utah, United States (RECRUITING)
- NEXT Oncology Virginia — Fairfax, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Astellas Pharma Inc.
- Email: Astellas.registration@astellas.com
- Phone: 800-888-7704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, Locally Advanced Solid Tumors, Metastatic Solid Tumors, ASP4396, KRAS G12D, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma