Study to Assess the Safety, Tolerability, and Pharmacokinetics of AMP-224 in Patients With Advanced Cancer
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 11/18/2012 |
Start Date: | March 2011 |
Contact: | Margaret Fleming |
Email: | clinicaltrials@amplimmune.com |
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
malignancy)
- Regular use of illicit drugs or a recent history of substance abuse
- Pregnant or breastfeeding women
We found this trial at
3
sites
3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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