Clinical Trial 21022

• Overview

  Study Title:

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

  Summary:

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

  Objective:

  1. To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors; 2. To characterize PK of product(s) used in investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors; 3. To evaluate anti-tumor activity of investigational regimens of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunotherapy; Therapy (NOS)

  Medications:

  AMG 404 (); AMG 510 (Sotorasib); FOLFIRI (); Not Applicable (); Panitumumab (); RMC-4630 (); Sotorasib (); Vectibix (Panitumumab)

• Inclusion 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.

• Exclusion Criteria

  • 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.

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