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Clinical Trial 21022

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04185883

Phase: Phase I/II
Principal Investigator: Haura, Eric

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or 1-800-679-0775 Learn More
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.

  • If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.