Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer

Therapuetic Areas:Oncology
Age Range:Any
Start Date:March 2011
Contact:Margaret Fleming

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This is a Phase 1, open-label, multi-center, first time in human study of AMP-224 in adult
patients with cancer that is not responding to standard therapy. This study will be
conducted in two stages consisting of a Dose-Escalation stage and an Expansion Stage.

Inclusion Criteria:

- Must be able to provide informed consent

- In Dose-Escalation: Must have solid tumor malignancy or cutaneous T-cell lymphoma
that has relapsed and is refractory to standard therapy, or for which no standard
therapy exists

- In Expansion Phase: Must have melanoma or ovarian cancer that is histologically or
cytologically confirmed

- Ovarian cancer patients must have recurrent of persistent non-mucinous disease, and
must not have received more than 2 prior chemotherapeutic regimens

- Melanoma patients must have recurrent or persistent non-ocular AJCC Stage IIIC or IV
disease that is surgically incurable and unresectable

- Melanoma patients with documented BRAF mutation that is known to be responsive to
BRAF inhibitors must have failed or be intolerant to such inhibitors

- Must have measurable disease

- Must be able to provide access to archival (Dose-Escalation Phase) and/or fresh tumor
tissue (Dose-Escalation and Expansion Phases) at Screening prior to study entry

- Must by at least 18 years old

- Must have adequate organ function

Exclusion Criteria:

- Prior cancer therapies must have completed at least 14 days or 5 half-lives
(whichever is longer) prior to first dose of AMP-224

- Prior treatment with an anti-PD1 antibody therapy

- Known antibody response against prior antibody therapy or fusion protein therapeutics

- Major surgery within 4 weeks prior to first dose of AMP-224

- Prior allogeneic or autologous bone marrow or organ transplantation

- Known and/or a history or evidence of autoimmune disease except vitiligo, resolved
childhood asthma and stable hypothyroidism

- Received an immunomodulatory drug within 2 weeks of first dose of AMP-224

- Active infections requiring antibiotics, physician monitoring, or recurrent fevers
>100.4 degrees fahrenheit associated with a clinical diagnosis of active infection

- Patients with cirrhosis

- Clinically significant cardiac or electrocardiogram abnormalities

- History or evidence of HIV

- Active viral disease (except when the viral infection is associated with the

- Regular use of illicit drugs or a recent history of substance abuse

- Pregnant or breastfeeding women
We found this trial at
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
Nashville, TN
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4100 John R
Detroit, Michigan 48201
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
Detroit, MI
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9801 W. Kincey Ave
Huntersville, North Carolina 28078
Huntersville, NC
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