MC# 19-37 - A Phase Ib, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation

  • Agent(s): AMG 510, PD1 Inhibitor, MEK inhibitor
  • Disease Type(s): Colorectal, Solid Tumor, Lung-NSCLC
  • Phase(s): I
  • Drug Classification(s): Targeted Therapy, Immunotherapy, Monoclonal Antibody, Small Molecule
  • Molecular Target(s): MEK, PD-1, KRAS G12C

Mechanism of Action

An orally available agent that targets the specific KRAS mutation, p.G12C, with potential antineoplastic activity.  Upon oral administration, KRAS mutant-targeting AMG 510 selectively targets the KRAS p.G12C mutant, at either the DNA, RNA or protein level, and prevents, through an as of yet not elucidated manner, expression of and/or tumor cell signaling through the KRAS p.G12C mutant.  This may inhibit growth in KRAS p.G12C-expressing tumor cells.  The KRAS p.G12C mutation is seen in some tumor cell types and plays a key role in tumor cell proliferation.

Purpose

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

Inclusion Criteria

AMG 510 Monotherapy and in Combination With Other Anti-cancer Therapies including a MEKi and PD1 inhibitor

  • Men or women greater than or equal to 18 years old
  • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through molecular testing
Exclusion Criteria

AMG 510 Monotherapy and in Combination With Other Anti-cancer Therapies including a MEKi and PD1 inhibitor

  • Primary brain tumor
  • 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

Location

  • Dallas, TX - Mary Crowley Cancer Research - Medical City
More Info: https://clinicaltrials.gov/ct2/show/NCT04185883

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Re: MC# 19-37