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A Phase 1 Study of AM0010 in Patients With Advanced Solid Tumors

Status: Recruiting
Phase: Phase 1
Diagnosis: Solid Tumor/Phase I
NCT ID: NCT02009449 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of AM0010 in patients with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute

Overall PI:
Patrick Ott, MD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623, andrew_wolanski@dfci.harvard.edu

Eligibility Criteria

Inclusion Criteria: - Advanced solid tumor, limited to melanoma, hormone refractory prostate cancer, ovarian cancer, renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the patient refuses existing therapies - Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) - At least 18 years of age - Performance Status of 0 or 1 - Adequate organ function Exclusion Criteria: - Hematologic malignancies - Pregnant or lactating - Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders - Myocardial infarction within the last 6 months - Unstable angina, or unstable cardiac arrhythmia requiring medication - Surgery within the last 28 days - Systemic fungal, bacterial, viral, or other infection - History of bleeding diathesis within the last 6 months - Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
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