Announcement of Availability for AMG 510 (Sotorasib)

June 01, 2021

The Cancer Therapy Evaluation Program (CTEP) is accepting Letters of Intent (LOIs) to conduct clinical studies using AMG 510 (sotorasib), a small molecule inhibitor of mutated KRASG12C, which is being developed by Amgen, in collaboration with CTEP, as an orally-available anticancer agent.

Potential areas of clinical interest include but are not limited to the evaluation of AMG 510 with tumors of squamous cell histology and KRAS G12C mutations.CTEP will also consider requests to supply AMG 510 for nonclinical or preclinical studies that may support the initiation of a clinical trial. All clinical and nonclinical researchers with an interest in studying AMG 510 are welcome to apply.

Proposals for clinical trials should be supported by a strong rationale and robust preclinical data (see “Components of a Competitive Letter of Intent” at http://ctep.cancer.gov/protocolDevelopment/lois_concepts.htm).

All proposals approved by CTEP will be sent to Amgen for a commitment to supply drug for the study.

Questions may be addressed to Dr. John Wright (wrightj@ctep.nci.nih.gov), Associate Branch Chief, Investigational Drug Branch, CTEP.

For more information please see related documents below.