M8891 First in Human in Solid Tumors



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/17/2019
Start Date:August 8, 2017
End Date:October 9, 2019
Contact:US Medical Information
Email:service@emdgroup.com
Phone:888-275-7376

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An Open-label, Phase I Dose Escalation Trial of Methionine Aminopeptidase 2 Inhibitor M8891 in Subjects With Advanced Solid Tumors

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.


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.

- Male or female subjects at least 18 years of age.

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.
We found this trial at
6
sites
New Haven, Connecticut 06510
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Baltimore, MD
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Detroit, Michigan 48202
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Detroit, MI
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Indianapolis, Indiana 46202
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Indianapolis, IN
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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New Brunswick, New Jersey 08903
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New Brunswick, NJ
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