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

MedImmune

Status and phase: Completed; Phase 1

Conditions: Cancer

Treatments: Drug: AMP-224

Study type: Interventional

Funder types: Industry

Identifiers

NCT01352884

AMP-224-01

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Stage 1

Experimental group

Description:

Stage 1 will identify the recommended Stage 2 dose using a dose-escalation process. Dose-escalation will continue until either a maximum tolerated dose is established, or a therapeutic dose is reached.

Treatment:

Drug: AMP-224

Drug: AMP-224

Stage 2

Experimental group

Description:

Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood specimens will be evaluated for pharmacodynamic markers/activity at specified timepoints throughout the study.

Treatment:

Drug: AMP-224

Drug: AMP-224