NCT07172919 A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
| NCT ID | NCT07172919 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Amgen |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 14 participants |
| Start Date | 2026-01-02 |
| Primary Completion | 2028-01-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 14 participants in total. It began in 2026-01-02 with a primary completion date of 2028-01-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
MD
STUDY DIRECTOR
Amgen
Frequently Asked Questions
Who can join the NCT07172919 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07172919 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07172919 currently recruiting?
Yes, NCT07172919 is actively recruiting participants. Contact the research team at medinfo@amgen.com for enrollment information.
Where is the NCT07172919 trial being conducted?
This trial is being conducted at Fort Myers, United States, Houston, United States, Randwick, Australia, Lyon, France and 7 additional locations.
Who is sponsoring the NCT07172919 clinical trial?
NCT07172919 is sponsored by Amgen. The principal investigator is MD at Amgen. The trial plans to enroll 14 participants.