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New drug targets tough cancers with specific gene flaw

NCT ID NCT06364696

Disease control Sponsor: Astellas Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This early-stage study tests a new drug called ASP4396 in adults with advanced solid tumors that have a specific KRAS G12D mutation. The drug is given by IV infusion, and the main goals are to check safety, find the right dose, and see how the body handles it. About 175 participants will take part in two parts: dose escalation and dose expansion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ASP4396
What this could lead to
If it works, this could lead to a new treatment option for people with certain hard-to-treat cancers that have a specific genetic mutation.
What could go wrong
This is a very early, first-in-human study, so the drug may not work or could cause serious side effects. It is only for people who have already tried other treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Apr 2024

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

colorectal neoplasm neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumor

Contacts and locations

Locations

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • NEXT Oncology Dallas

    Irving, Texas, 75039, United States

  • NEXT Oncology Virginia

    Fairfax, Virginia, 22031, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • START Mountain Region

    West Valley City, Utah, 84119, United States

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Rochester

    Rochester, New York, 14627, United States

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