Study Sponsor: Amgen Inc.

Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center

Phase of Study: Phase I

Purpose of study: The purpose of the study is to determine the maximum tolerated dose of study drug AMG193 given as a single drug, or in combination with other anti-cancer drugs in patients with metastatic or locally advanced MTAP-deleted lung cancer. The study drug AMG193 works by preferentially targeting tumor cells that lack the MTAP gene.

Inclusion Criteria:

– Must be at least 18 years or older at time of consent.

– Confirmed metastatic non small cell lung cancer without prior therapy for metastatic disease.

– MTAP-deletion per local NGS testing, OR MTAP protein loss per local IHC testing (discussed in greater detail with physician).

– Must have archival tumor tissue to submit to the study (tumor sample must be collected within the last 5 years).

– Must be able to swallow oral study drug.

– ECOG status of 0-1.

– Must have adequate organ function as determined by local lab tests

– Minimum life expectancy of at least 12 weeks in the opinion of the treating physician.

Additional inclusion criteria may apply, and will be discussed with the research team and physician.

 

Exclusion Criteria:

– Has had prior treatment for metastatic non small cell lung cancer. (Exception for patients that started standard platinum chemo or immunotherapy that receive their first dose within 28 days of signing the informed consent. Discuss with research team and physician for more detailed information)

– Has had a major surgery within 28 days prior to the first dose of the study drug (a fresh biopsy to fulfil the inclusion criteria is allowed)

– Side effects from prior treatments that have not resolved (some exceptions apply – such as hair loss or side effects that are well controlled)

– Has received radiation therapy within 28 days of the first dose of study drug.

– Has received a live vaccine within 4 week prior to first dose.

– Has untreated symptomatic brain metastasis, or asymptomatic brain metastasis lesions bigger than 2cm.

– Has Leptomeningeal disease.

– Ascites requiring drainage more than 1 time per month. Patients with PleurX catheters may be considered eligible after discussion and study medical monitor approval.

– Significant heart condition(s) (to be discussed in greater detail with research team and physician).

– Gastrointestinal disease causing inability to swallow oral study drug, or other significant gastrointestinal issues (to be discussed in greater detail with research team and physician).

– Has had a solid organ transplant.

– Known positive HIV (Subject may be eligible if they have no detectable viral load).

– Positive for hepatitis B or C.

– Female patients of childbearing potential, or male patients with partners that are of childbearing potential that are unwilling to use highly effective methods of contraception while on study are considered ineligible. Additionally, if patients agree to contraceptives, they must not donate eggs or sperm for a period of time from the first dose to 6 months after the last dose of study drug(s).

Additional exclusionary criteria may apply and are to be discussed in greater detail with the research team and physician.

 

Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com  

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