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

NCT07172919 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: 202500892025-522355-26U1111-1322-4422
• Study Type: interventional
• Target: 14
• Locations: 8 countries
• Sites: 9

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced solid tumors; Sotorasib; Panitumumab; AMG 510

Outcome Measures

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.

  Up to approximately 18 months

Study Arms (2)

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.

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.

Drug: Sotorasib; Drug: Panitumumab

Interventions

Sotorasib DRUG

Sotorasib will be administered orally as a tablet.

Also known as: AMG 510

Arm A: Sotorasib; Arm B: Sotorasib in Combination with Panitumumab

Panitumumab DRUG

Panitumumab will be administered as an IV infusion.

Arm B: Sotorasib in Combination with Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• days after the last dose of sotorasib.
• months after the last dose of panitumumab.
• Female participants who are breastfeeding or who plan to breastfeed while on study through:
• days after the last dose of sotorasib.
• months after the last dose of panitumumab.
• Female participants planning to become pregnant while on study through:
• days after the last dose of sotorasib.
• months after the last dose of panitumumab.

Sponsors & Collaborators

• Amgen: lead

Study Sites (9)

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

RECRUITING

Centre Leon Berard

Lyon, 69008, France

RECRUITING

Evangelische Lungenklinik

Berlin, 13125, Germany

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

RECRUITING

Universitaetsspital Basel

Basel, 4031, Switzerland

RECRUITING

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

sotorasib; Panitumumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: January 2, 2026
• Primary Completion (Estimated): January 2, 2028
• Study Completion (Estimated): January 2, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (2); TW (1); FR (1); DE (1); IT (1); AU (1); CH (1); JP (1)