Advanced Solid TumorsPhase 2NCT07172919
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
A Phase 2 study testing Sotorasib and Panitumumab in people with Advanced Solid Tumors, run by Amgen at 11 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Sotorasib and Panitumumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 11 sitesin 9 countries
- Study dates
- 2 Jan 2026to 1 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
11 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 9 countries
United States2 sites, 2 recruiting
- Recruiting
Florida Cancer Specialists - Fort Myers
Fort Myers, Florida, 33901
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Greece2 sites, 2 recruiting
- Recruiting
Henry Dunant Hospital Center
Athens, 11526
- Recruiting
Theagenion Cancer Hospital
Thessaloniki, 54007
Australia1 site
- Terminated
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Japan1 site
- Terminated
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804
Switzerland1 site, 1 recruiting
- Recruiting
Universitaetsspital Basel
Basel, 4031
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
About this study
Official 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
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- Sotorasib, Panitumumab
- Keywords
- Advanced solid tumors, Sotorasib, Panitumumab, AMG 510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotorasibDrug
Also called AMG 510
Sotorasib will be administered orally as a tablet.
PanitumumabDrug
Panitumumab will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Sotorasib | Experimental | Sotorasib will be administered once daily, orally in 28-day treatment cycles for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first. Receives: Drug: Sotorasib |
| Arm B: Sotorasib in Combination with Panitumumab | Experimental | Sotorasib will be administered once daily, orally, in combination with Panitumumab intravenous (IV) infusion every two weeks on Day 1 and Day 15 in 28-day treatment cycles. Treatment will continue for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first. Receives: Drug: Sotorasib; Drug: Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Incidence and severity of TEAEs, clinically significant changes in vital signs, and clinical laboratory tests will be reported as TEAEs.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start2 Jan 2026
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07172919
- Sponsor's protocol ID
- 20250089
- Other IDs
- 2025-522355-26, U1111-1322-4422, 2025
- Status last verified
- Jul 2026
- First submitted
- 8 Sep 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07172919
- Acronym / sponsor ID
- 20250089
- Conditions
- Advanced Solid Tumors
- Keywords
- Advanced solid tumors, Sotorasib, Panitumumab, AMG 510
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2026 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 15 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Sotorasib | Experimental | Drug: SotorasibSotorasib will be administered once daily, orally in 28-day treatment cycles for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first. |
| Arm B: Sotorasib in Combination with Panitumumab | Experimental | Drug: Sotorasib, Drug: PanitumumabSotorasib will be administered once daily, orally, in combination with Panitumumab intravenous (IV) infusion every two weeks on Day 1 and Day 15 in 28-day treatment cycles. Treatment will continue for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SotorasibAlso: AMG 510Sotorasib will be administered orally as a tablet. | Drug | Arm A: Sotorasib, Arm B: Sotorasib in Combination with Panitumumab |
| PanitumumabPanitumumab will be administered as an IV infusion. | Drug | Arm B: Sotorasib in Combination with Panitumumab |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
11 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sotorasib and Panitumumab in people with Advanced Solid Tumors, run by Amgen at 11 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Greece, Australia, France, Germany and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.