A Phase 1, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.



Status:Recruiting
Healthy:No
Age Range:18 - 100
Updated:4/6/2019
Start Date:August 27, 2018
End Date:April 29, 2024
Contact:Amgen Call Center
Email:medinfo@amgen.com
Phone:866-572-6436

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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

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.


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.

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)
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