A Phase 1 Study to Evaluate AMP-514

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Amplimmune
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
Amplimmune
ClinicalTrials.gov Identifier:
NCT02013804
First received: December 12, 2013
Last updated: December 18, 2013
Last verified: December 2013

December 12, 2013
December 18, 2013
December 2013
August 2015   (final data collection date for primary outcome measure)
Number of subjects experiencing dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs) [ Time Frame: Through 90 days after last dose of AMP-514 ] [ Designated as safety issue: Yes ]
Maximum tolerated dose (MTD) or optimal biological dose (OBD) will be determined by the number of subjects experiencing DLTs. Safety profile will be assessed through the number of subjects experiencing AEs, SAEs, abnormal laboratory evaluations, vital signs, and physical examinations.
Same as current
Complete list of historical versions of study NCT02013804 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic profile of AMP-514 [ Time Frame: Through 90 days after the last dose of AMP-514 ] [ Designated as safety issue: No ]
    AMP-514 concentrations in serum and PK parameters including peak concentration, area under the concentration-time curve, clearance, and half-life.
  • Assess preliminary antitumor activity of AMP-514 [ Time Frame: Approximately every 3 months through 12 months following last cycle of AMP-514 ] [ Designated as safety issue: No ]
    Disease status evaluated via RECIST 1.1.
  • Evaluate pharmacodynamic effects of AMP-514 on its target receptor, PD-1, as well as effects on immune system function [ Time Frame: Approximately every 3 months through 12 months following last cycle of AMP-514 ] [ Designated as safety issue: No ]
    Includes assessment of receptor occupancy, reduction in PD-1 expression levels, and increase in T cells producing effector cytokines and lytic markers
Same as current
Not Provided
Not Provided
 
A Phase 1 Study to Evaluate AMP-514
A Phase 1, Multi-Center, Open-label, Multi-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AMP-514 in Subjects With Advanced Solid Malignancies

This is a multi-center, open-label, multi-dose, first-time-in-human study with a standard 3+3 dose-escalation phase in subjects with advanced solid malignancies.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Malignancies
Drug: AMP-514
AMP-514 will be administered by IV infusion every 21 days
Other Name: MEDI0680
Experimental: AMP-514
Escalating doses of AMP-514
Intervention: Drug: AMP-514
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
July 2016
August 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • ≥18 years of age at time of study entry
  • Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA]) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
  • Life Expectancy of ≥ 12 weeks
  • Histologically- or cytologically-confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists
  • At least 1 measurable lesion per RECIST 1.1; subjects whose only measurable lesion is a lymph node will be excluded
  • ECOG Performance Score of 0 or 1
  • Adequate organ and marrow function
  • Prior treatment toxicities must be ≤ Grade 1
  • Willingness to provide consent for biopsy samples
  • Females of childbearing and unsterilized males must use 2 methods of effective contraception from screening, and must agree to continue using such precautions for 90 days after the final dose of AMP-514

Exclusion Criteria:

  • Concurrent enrollment in another clinical study, unless it is an observational (non interventional) clinical study or the follow-up period of an interventional study
  • Receipt of any immunotherapy, BRAF inhibitor (in metastatic melanoma), or investigational anticancer therapy within 4 weeks prior to the first dose of AMP-514; in the case of monoclonal antibodies, 6 weeks prior to the first dose of AMP-514
  • Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
  • Any prior Grade ≥3 immune-related adverse event (irAE) while receiving immunotherapy or any unresolved irAE > Grade 1
  • Major surgery (as defined by the investigator) within 4 weeks prior to first dose of AMP-514 or still recovering from prior surgery
  • Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured
  • Prior allogeneic or autologous bone marrow or organ transplantation that requires use of immunosuppressives
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to National Cancer Institute's (NCI's) Common Terminology Criteria for Adverse Events (CTCAE) (NCI CTCAE v4.03) Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria with the exception of alopecia. Subjects with irreversible toxicity that is not reasonably expected to be exacerbated by AMP-514 may be included (eg, hearing loss) after consultation with the MedImmune medical monitor.
  • Active or prior documented autoimmune disease within the past 2 years NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
  • History of primary immunodeficiency
  • Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions (eg, insulin for diabetes and hormone replacement therapy) is acceptable. NOTE: Local treatment of isolated lesions for palliative intent is acceptable (eg, by local surgery or radiotherapy)
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of AMP-514, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent
  • Uncontrolled intercurrent illness
  • Symptomatic or untreated central nervous system metastases requiring concurrent treatment
  • Known history of tuberculosis
  • Subjects who are known to be human immunodeficiency virus positive
  • Subjects who are known to be hepatitis B or C positive
  • Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving AMP-514
  • Pregnant or breastfeeding women
Both
18 Years and older
No
United States
 
NCT02013804
AMP-514-01, MEDI0680
Yes
Amplimmune
Amplimmune
MedImmune LLC
Study Director: Solomon Langermann, PhD Amplimmune
Amplimmune
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP