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Advanced Solid Tumors w/ KRAS Mutation (AMG 820- 20150195)

A Phase 1, First-in-Human, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 in Subjects With Advanced Solid Tumors With a Specific KRAS Mutation

Objective

Overview

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose [RP2D]) within investigated subject population groups.

Key Inclusion Criteria

Inclusion Criteria:

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

    • Subjects must have received prior standard therapy appropriate for their tumor type and stage of disease, or in the opinion of the Investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy.

Key Exclusion Criteria

Exclusion Criteria:

  • Active brain metastases from non-brain tumors.

    -- History or presence of hematological malignancies unless curatively treated with no evidence of disease

  • Myocardial infarction within 6 months of study day 1.
  • Symptomatic congestive heart failure (New York Heart Association greater than class II)
  • Unstable angina
  • Cardiac arrhythmia requiring medication
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.
  • Active infection requiring intravenous (IV) antibiotics within 1 weeks of study enrollment (day 1)
  • Positive Hepatitis B Surface Antigen (HepBsAg) or positive Hepatitis total core antibody with negative HepBsAg
  • Detectable Hepatitis C virus
  • Known positive test for HIV
  • Unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (Grade 2 or 3 toxicities from prior anti-tumor therapy that are considered irreversible [defined as having been present and stable for greater than 6 months] may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor)

Phase: I

Learn More

ClinicalTrials.Gov

IRB Protocol Number
AMG 820- 20150195
Principal Investigator(s)
Vikas Dembla, M.D.

Clinical Trial Categories

  • Phase I
  • Precision Medicine & Rare Tumors
  • Oncology
Contact
Kenneth A. Kuenzli II, RN at 864-560-7579
or kkuenzli@gibbscc.org
How to Participate

Kenneth A. Kuenzli II, RN
864-560-7579
kkuenzli@gibbscc.org

Location

  • Gibbs Cancer Center & Research Institute – Spartanburg
    380 Serpentine Drive
    Spartanburg, SC 29303

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