A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

Last updated: May 13, 2026
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Panitumumab

Sotorasib

Clinical Study ID

NCT07172919
20250089
2025-522355-26
U1111-1322-4422
  • Ages > 18
  • All Genders

Study Summary

The primary objective of the study is to evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.

Eligibility Criteria

Inclusion

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 sotorasibthrough the use of a written diary.

  • Participant is currently receiving treatment with sotorasib alone or in combinationtherapy in an Amgen-sponsored trial that has met its endpoints or otherwise will bestopping (also referred to as parent study) and are continuing to receive clinicalbenefit in the opinion of the investigator.

  • For a participant on combination therapy in their parent study, treatment with otheranti-cancer therapies is allowed provided it matches the parent study.

  • Eastern Cooperative Oncology Group Performance Status of ≤ 2.

Exclusion

Exclusion Criteria:

  • Participant had permanently discontinued from sotorasib study treatment in theparent study before the parent study's completion.

  • Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at thetime of the termination of the parent study.

  • Local access to commercially available investigational product(s) at no cost to theparticipant as permitted by local/country regulation.

  • Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit tothe 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 withprotocol procedures or interpretation of results or that pose a risk to participantsafety, in the opinion of the investigator.

  • Female participants of childbearing potential unwilling to use protocol-specifiedmethod 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 studythrough:

  • 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 testassessed 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 unwillingto practice sexual abstinence (refrain from heterosexual intercourse) or usecontraception during treatment and for an additional 7 days after the last dose ofsotorasib.

  • Male participants with a pregnant partner who are unwilling to practice abstinenceor use a condom during treatment and for an additional 7 days after the last dose ofsotorasib.

  • Male participants unwilling to abstain from donating sperm during treatment and foran additional 7 days after the last dose of sotorasib.

Study Design

Total Participants: 14
Treatment Group(s): 2
Primary Treatment: Panitumumab
Phase: 2
Study Start date:
January 02, 2026
Estimated Completion Date:
January 02, 2028

Connect with a study center

  • Scientia Clinical Research Ltd

    Randwick, New South Wales 2031
    Australia

    Active - Recruiting

  • Centre Leon Berard

    Lyon, 69008
    France

    Active - Recruiting

  • Evangelische Lungenklinik

    Berlin, 13125
    Germany

    Active - Recruiting

  • Henry Dunant Hospital Center

    Athens, 11526
    Greece

    Active - Recruiting

  • Theagenion Cancer Hospital

    Thessaloniki, 54007
    Greece

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 00168
    Italy

    Active - Recruiting

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido 003-0804
    Japan

    Active - Recruiting

  • Universitaetsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Universitaetsspital Basel

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung 1668399, 40705
    Taiwan

    Site Not Available

  • Florida Cancer Specialists - Fort Myers

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

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