A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors

Plain-language summary

This study aims to find a suitable dose of the drug ASP4396 in adults with advanced solid tumors that carry the KRAS G12D mutation. It enrolls adults who have received prior standard therapy, have at least one measurable lesion, and are in adequate general condition (ECOG 0-1). The study is in Phase 1; it is not recruiting at the moment but is still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Active, not recruiting

Sponsor

Astellas Pharma Inc

Intervention

ASP4396

Start date

4/16/2024

Estimated completion

4/30/2027

Countries

United States

Related genes

Locations

• Westwood, United States
• Grand Rapids, United States
• New York, United States
• Rochester, United States
• Irving, United States
• West Valley City, United States
• Fairfax, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.