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New hope for Hard-to-Treat cancers: targeted drug tested in chinese patients

NCT ID NCT04380753

Disease control Sponsor: Amgen 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested the drug sotorasib (AMG 510) in 12 Chinese patients with advanced solid tumors that have a specific KRAS G12C mutation. The main goals were to check safety, how the drug moves through the body, and whether it shrinks tumors. All participants took the drug by mouth once daily.

What this could mean

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

Active substance
AMG 510 (sotorasib)
What this could lead to
If successful, this could confirm that sotorasib is safe and effective for Chinese patients with KRAS G12C-mutated cancers, potentially expanding access to a targeted therapy.
What could go wrong
This is a very early (Phase 1) and small (12 participants) study focused on safety and dosing, not proof of benefit. Results may not generalize to larger populations, and side effects like liver or gastrointestinal issues are possible.

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

12 people

The number who actually took part.

Started

Apr 2020

Finished

Feb 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 to 100 years

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 * Male or female subjects greater than or equal to 18 years old * Subject is of Chinese ancestry * Pathologically documented, advanced/metastatic solid tumor with KRAS p.G12C mutation identified Exclusion Criteria: * Active brain metastases from non-brain tumors. * Myocardial infarction within 6 months of study day 1. * Gastrointestinal (GI) tract disease causing the inability to take oral medication

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As listed by the trial registrant

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

Advanced/metastatic solid tumors with KRAS P.G12C mutation

Contacts and locations

Locations

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Prince of Wales Hospital

    Shatin, New Territories, Hong Kong

  • University of Hong Kong, Queen Mary Hospital

    Hong Kong, Hong Kong

  • Veterans General Hospital - Taichung

    Taichung, 40705, Taiwan