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A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Status
Closed
Cancer Type
Lung Cancer
Solid Tumor
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 - 100 Years, Male and Female
Study Type
Treatment
NCT ID
NCT03600883
Protocol IDs
20170543 (primary)
NCI-2018-01725
Study Sponsor
Amgen, Inc.

Summary

Evaluate the safety and tolerability of sotorasib in adult subjects with KRAS p.G12C mutant
advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult
subjects with KRAS p.G12C mutant advanced solid tumors.

Eligibility

  1. Men or women greater than or equal to 18 years old.
  2. Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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Georgia CORE

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.