This study is in progress, not accepting new patients

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)

a study on Solid Tumor Non-Small Cell Lung Cancer Neoplasms

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around
Principal Investigator
by Jonathan Goldman

Description

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.

Official Title

A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Sotorasib (AMG 510) Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and Sotorasib (AMG 510) Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C Mutation (CodeBreaK 100)

Keywords

KRAS p.G12C Mutant Advanced Solid Tumors, Neoplasms, Sotorasib, Midazolam, Anti PD-1/L1

Eligibility

You can join if…

Open to people ages 18-100

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

You CAN'T join if...

  • Active brain metastases from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Locations

  • University of California Los Angeles
    Los Angeles California 90095 United States
  • Sarcoma Oncology Research Center LLC
    Santa Monica California 90403 United States
  • City of Hope National Medical Center
    Duarte California 91010 United States

Lead Scientist at UCLA

  • Jonathan Goldman
    Hs Clinical Professor, Medicine. Authored (or co-authored) 110 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT03600883
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 713 people participating
Last Updated