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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
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 or immunotherapy.


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

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

Site-responsible Investigators:

Dana-Farber Cancer Institute: Andrew Wolanski, 617-632-6623,

Eligibility Criteria

Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), 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 Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: - Tumors with all histological diagnosis or tissue origin may be enrolled - Patients must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which AM0010 is added represents an acceptable standard treatment for their disease. - 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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