Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

Description

Summary

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Official Title

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN) Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Keywords

Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation Sarcoma Neoplasms Sotorasib PD1 inhibitor MEK inhibitor SHP2 allosteric inhibitor Pan-ErbB tyrosine kinase inhibitor PD-L1 inhibitor EGFR inhibitor Chemotherapeutic regimen PD-1 inhibitor Sotorasib+ MEK inhibitor Sotorasib + PD1 inhibitor Sotorasib+ SHP2 allosteric inhibitor Sotorasib+ Pan-ErbB tyrosine kinase inhibitor Sotorasib + PD-L1 inhibitor Sotorasib + PD-1 inhibitor

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...

  • Primary brain tumor.
  • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease 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

  • Research Site accepting new patients
    Sacramento California 95817 United States
  • Research Site accepting new patients
    Santa Monica California 90404 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website Sign up for this study
ID
NCT04185883
Phase
Phase 1
Study Type
Interventional
Last Updated