Cancer

AMGEN 20190135

A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation

Trial overview

Topic

Basket – Solid Tumours

Description

A Phase 1b/2, Master Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 (pINN Sotorasib) in Subjects With Advanced Solid Tumours With KRAS p.G12C Mutation

Eligibility criteria

  • 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.
  • Exhausted other standard of care options for locally advanced and unresectable or metastatic disease including platinum-based combination chemotherapy and programmed cell death protein 1/programmed death-ligand 1 (PD 1/PD-L1) immunotherapy (unless contraindicated)
  • Performance Status ≤ 2

Study details

Primary Objective:

  • To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumours.

Secondary Objectives:

  • To characterize PK of product(s) used in investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumours.

Further information:

Please click here for more information.

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