Sotorasib with or without Panitumumab for Advanced Solid Tumors
This study is for people with advanced solid tumors that have a specific change in the KRAS gene (called p.G12C mutation). It is testing the safety of continuing treatment with sotorasib, either alone or with panitumumab. You can join if you are already receiving sotorasib in another Amgen-sponsored trial and are still benefiting from it. The main goal is to see how many participants experience side effects from the treatments over about 18 months. This study plans to enroll 14 participants, but its current status is unclear.
- Study design
- This study is evaluating sotorasib with or without panitumumab in 14 participants. The phase of the study is not specified.
- What's involved
- You would need to be able to take oral medications and record your daily sotorasib use in a written diary. The study will evaluate safety for up to approximately 18 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure treatment-emergent adverse events for up to approximately 18 months.
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NCT07172919
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
Recruiting
PHASE2Ages 18+InterventionalTreatmentAmgen
~14 participants
Updated 2026-07-23 on ClinicalTrials.gov
What's tested:SotorasibPanitumumab
At a glance
Recruiting sites
9 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Measured over Up to approximately 18 months
Conditions
Where it's being run
11 sites across 10 statesGreece2
Florida1
Texas1
New South Wales1
France1
Germany1
Italy1
Hokkaido1
Study leadership
- MD · STUDY_DIRECTOR · Amgen
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs)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.