An Open-label Phase I Dose Escalation Trial of Methionine Aminopeptidase 2 Inhibitor M8891 in Subjects With Advanced Solid Tumors
Bert O'Neil, MD
Primary Investigator
Overview
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic and antitumor activity of M8891 as single agent in subjects with solid tumors.
Description
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, Pharmacokinetic and antitumor activity of M8891 as single agent in subjects with solid tumors.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Solid Tumor,Cancer,Advanced Solid Tumors
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Age: Between 18 Years - 100 Years
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Gender: All
Inclusion Criteria
Subjects must be refractory to or intolerant of existing cancer therapy(ies) known to provide clinical benefit
Histologically confirmed advanced solid tumors with no clear curative treatment options available after at least 1 prior systemic anticancer therapy
Tumor accessible for biopsies and agreement to conduct pre-dose and post-dose fresh tumor biopsies.
Exclusion Criteria
ECOG PS >= 2
Extensive prior radiotherapy on more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation within 5 years of study start
Severe bone marrow, renal or liver impairment
Presence of deep vein thrombosis based on screening lower extremity Doppler ultrasonography, or elevated D-dimer (> 0.5 microgram per millilter (?g/mL))
