CClinicalTrials.gg
RecruitingNCT07172919Updated Jul 23, 2026

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

A Phase 2 interventional study of Sotorasib and Panitumumab in Advanced Solid Tumors, sponsored by Amgen. Recruiting at 11 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Amgen · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors

Keywords

  • Advanced solid tumors
  • Sotorasib
  • Panitumumab
  • AMG 510
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    Arm A: Sotorasib

    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.

    Drug: Sotorasib

  • Experimental
    Arm B: Sotorasib in Combination with Panitumumab

    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.

    Drug: Sotorasib · Drug: Panitumumab

Interventions

  • DrugSotorasib

    Sotorasib will be administered orally as a tablet.

    Also known as: AMG 510

  • DrugPanitumumab

    Panitumumab will be administered as an IV infusion.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 18 months

07

Study locations

9 of 11 sites recruiting
  • Florida Cancer Specialists - Fort Myers
    Fort Myers, Florida 33901, United States
    Recruiting
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
    Recruiting
  • Scientia Clinical Research Ltd
    Randwick, New South Wales 2031, Australia
    Terminated
  • Centre Leon Berard
    Lyon, 69008, France
    Recruiting
  • Evangelische Lungenklinik
    Berlin, 13125, Germany
    Recruiting
  • Henry Dunant Hospital Center
    Athens, 11526, Greece
    Recruiting
  • Theagenion Cancer Hospital
    Thessaloniki, 54007, Greece
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Roma, 00168, Italy
    Recruiting
  • National Hospital Organization Hokkaido Cancer Center
    Sapporo, Hokkaido 003-0804, Japan
    Terminated
  • Universitaetsspital Basel
    Basel, 4031, Switzerland
    Recruiting
  • Taichung Veterans General Hospital
    Taichung, 40705, Taiwan
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07172919
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 15, 2025
Start date
Jan 2, 2026
Primary completion
Jul 1, 2028 (estimated)
Completion
Jul 1, 2028 (estimated)
Last update
Jul 23, 2026

Study contacts

Amgen Call Center
Contact
medinfo@amgen.com
866-572-6436
MD
study director · Amgen

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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