Continuing sotorasib with or without panitumumab for adults with KRAS p.G12C advanced solid tumors

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

This trial tries continuing sotorasib, with or without panitumumab, in adults with KRAS p.G12C advanced solid tumors who are already benefiting from an Amgen trial to see if ongoing treatment remains safe and tolerable.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amgen (industry)
• Drugs / interventions: panitumumab
• Locations: 9 sites (Fort Myers, Florida and 8 other locations)
• Trial ID: NCT07172919 on ClinicalTrials.gov

What this trial studies

This Phase 2 rollover interventional protocol enrolls adults with advanced solid tumors harboring the KRAS p.G12C mutation who are already receiving sotorasib in an Amgen-sponsored parent trial and are judged by their investigator to be deriving clinical benefit. Participants continue sotorasib with or without panitumumab and may continue other anti-cancer therapies if they match the parent study regimen. The primary objective is to monitor the safety and tolerability of continued sotorasib-based regimens, with collection of adverse events and treatment interruption data. Key eligibility includes age ≥18, ECOG performance status ≤2, life expectancy >3 months, and the ability to take oral medications and record adherence.

Who should consider this trial

Good fit: Adults (≥18) with KRAS p.G12C advanced solid tumors who were receiving sotorasib in an Amgen parent trial, are still deriving benefit per their investigator, have ECOG ≤2, and a life expectancy >3 months.

Not a fit: Patients who permanently stopped sotorasib for toxicity, discontinued before the parent study completed, or who have unresolved toxicities requiring interruption are unlikely to receive benefit from continued therapy in this protocol.

Why it matters

Potential benefit: If successful, this could let patients keep a treatment that is controlling their cancer while closely monitoring and managing side effects.

How similar studies have performed: Single-agent sotorasib has demonstrated tumor responses in KRAS G12C cancers and combinations with EGFR inhibitors like panitumumab are under active investigation, but the rollover design is mainly intended to document safety and provide continued access rather than to establish new efficacy claims.

Eligibility criteria

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.

Where this trial is running

Fort Myers, Florida and 8 other locations

• Florida Cancer Specialists - Fort Myers — Fort Myers, Florida, United States (RECRUITING)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Scientia Clinical Research Ltd — Randwick, New South Wales, Australia (RECRUITING)
• Centre Leon Berard — Lyon, France (RECRUITING)
• Evangelische Lungenklinik — Berlin, Germany (RECRUITING)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (RECRUITING)
• National Hospital Organization Hokkaido Cancer Center — Sapporo, Hokkaido, Japan (RECRUITING)
• Universitaetsspital Basel — Basel, Switzerland (RECRUITING)
• Taichung Veterans General Hospital — Taichung, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Amgen Call Center

Conditions: Advanced Solid Tumors, Advanced solid tumors, Sotorasib, Panitumumab, AMG 510