Recruiting
Phase 2

Sotorasib & Panitumumab

Sponsor:

Amgen

Code:

NCT07172919

Conditions

Advanced Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sotorasib

Panitumumab

Study Details

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

Study ID

NCT07172919

Start date

Jan 2, 2026

Status verified date

Jul, 2026

Completion date

Jul 1, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

14 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Sotorasib

Sotorasib will be administered orally as a tablet.

Panitumumab

Panitumumab will be administered as an IV infusion.

Primary outcome measure

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 18 months ]

Central Contacts and Locations

Central contacts

Amgen Call Center

866-572-6436medinfo@amgen.com

Locations

Florida Cancer Specialists - Fort Myers

Recruiting

Fort Myers, Florida, United States, 33901

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

More Information

Sponsor

Amgen

Last update posted

Jul 23, 2026

Last verified

Jul, 2026

Keywords

  • Advanced solid tumors
  • Sotorasib
  • Panitumumab
  • AMG 510

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Amgen on 2026-07-23.