New drug targets tough cancers with specific gene flaw

NCT ID NCT06364696

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

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.

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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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