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Cancer patients who responded to sotorasib can keep taking it in this safety follow-up study

NCT ID NCT07172919

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Updated 2 times

Summary

This study is for people with advanced solid tumors who have a specific gene change (KRAS G12C) and are already doing well on sotorasib (with or without panitumumab) from a previous Amgen trial. It allows them to keep receiving the treatment while doctors monitor safety and side effects. About 14 adults who can take oral medication and have a life expectancy over 3 months may join.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

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: * Signed informed consent. * Age ≥ 18 years. * Life expectancy of \> 3 months, in the opinion of the investigator. * Ability to take oral medications and willing to record daily adherence to sotorasib through the use of a written diary. * Participant is currently receiving treatment with sotorasib alone or in combination therapy in an Amgen-sponsored trial that has met its endpoints or otherwise will be stopping (also referred to as parent study) and are continuing to receive clinical benefit in the opinion of the investigator. * For a participant on combination therapy in their parent study, treatment with other anti-cancer therapies is allowed provided it matches the parent study. * Eastern Cooperative Oncology Group Performance Status of ≤ 2. Exclusion Criteria: * Participant had permanently discontinued from sotorasib study treatment in the parent study before the parent study's completion. * Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at the time of the termination of the parent study. * Local access to commercially available investigational product(s) at no cost to the participant as permitted by local/country regulation. * Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit to the participant in the opinion of the investigator. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. * Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to participant safety, in the opinion of the investigator. * Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional: * 7 days after the last dose of sotorasib. * 2 months after the last dose of panitumumab. * Female participants who are breastfeeding or who plan to breastfeed while on study through: * 7 days after the last dose of sotorasib. * 2 months after the last dose of panitumumab. * Female participants planning to become pregnant while on study through: * 7 days after the last dose of sotorasib. * 2 months after the last dose of panitumumab. * Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a highly sensitive urine or serum pregnancy test. * Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib. * Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib. * Male participants unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of sotorasib.

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As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    9 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Evangelische Lungenklinik

    RECRUITING

    Berlin, 13125, Germany

  • Florida Cancer Specialists - Fort Myers

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Henry Dunant Hospital Center

    RECRUITING

    Athens, 11526, Greece

  • National Hospital Organization Hokkaido Cancer Center

    TERMINATED

    Sapporo, Hokkaido, 003-0804, Japan

  • Scientia Clinical Research Ltd

    TERMINATED

    Randwick, New South Wales, 2031, Australia

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Theagenion Cancer Hospital

    RECRUITING

    Thessaloniki, 54007, Greece

  • Universitaetsspital Basel

    RECRUITING

    Basel, 4031, Switzerland

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

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