Cancer patients who responded to sotorasib can keep taking it in this safety follow-up study
NCT ID NCT07172919
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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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Genom att skicka in godkänner du våra Användarvillkor
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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
9 sites in 7 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Centre Leon Berard
RECRUITINGLyon, 69008, France
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Evangelische Lungenklinik
RECRUITINGBerlin, 13125, Germany
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Florida Cancer Specialists - Fort Myers
RECRUITINGFort Myers, Florida, 33901, United States
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRoma, 00168, Italy
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Henry Dunant Hospital Center
RECRUITINGAthens, 11526, Greece
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National Hospital Organization Hokkaido Cancer Center
TERMINATEDSapporo, Hokkaido, 003-0804, Japan
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Scientia Clinical Research Ltd
TERMINATEDRandwick, New South Wales, 2031, Australia
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Taichung Veterans General Hospital
RECRUITINGTaichung, 40705, Taiwan
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Theagenion Cancer Hospital
RECRUITINGThessaloniki, 54007, Greece
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Universitaetsspital Basel
RECRUITINGBasel, 4031, Switzerland
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University of Texas MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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