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NCT Number: NCT07172919

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Scientia Clinical Research Ltd, Randwick, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sotorasib

Drug

Sotorasib will be administered orally as a tablet.

Other names: AMG 510

Panitumumab

Drug

Panitumumab will be administered as an IV infusion.

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 18 months

    Incidence and severity of TEAEs, clinically significant changes in vital signs, and clinical laboratory tests will be reported as TEAEs.

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Rollover Study of Sotorasib With or Without Panitumumab for the Treatment of Cancer Subjects With KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 15, 2025
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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