A Study in Adult Subjects With Select Advanced Solid Tumors

NCT ID: NCT02583165

Last Updated: 2019-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-09

Study Completion Date

2018-12-19

Brief Summary

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To evaluate the safety and tolerability of MEDI1873 in adult subjects with selected advanced solid tumors.

Detailed Description

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This is a first-time-in-human, Phase 1, multicenter, open-label, single-arm dose-escalation study of MEDI1873 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and anti-tumor activity in adult subjects with advanced solid tumor malignancies

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy arm

MEDI1873

Group Type EXPERIMENTAL

MEDI1873

Intervention Type BIOLOGICAL

Subjects will receive MEDI1873 by intravenous administration

Interventions

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MEDI1873

Subjects will receive MEDI1873 by intravenous administration

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* All subjects must consent to provide archived tumor specimen
* Subjects must have histologically or cytologically confirmed advanced solid tumor for recurrent or metastatic disease.
* At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated and must be asymptomatic
* Willingness to provide pretreatment and on-treatment biopsies.
* Adequate organ function
* Females of childbearing potential and nonsterilized males who are sexually active must use effective methods of contraception

Exclusion Criteria

* Known allergic reaction to any component of MEDI1873
* Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
* Receipt of any anticancer therapy within 4 weeks prior to the first dose of MEDI1873; in the case of mAbs, 6 weeks prior to the first dose of MEDI1873
* Any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment.
* Receipt of live, attenuated vaccine within 28 days prior to the first dose of investigational product
* Unresolved toxicities from prior anticancer therapy
* Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medimmune LLC

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

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Research Site

Phoenix, Arizona, United States

Site Status

Research Site

Scottsdale, Arizona, United States

Site Status

Research Site

Los Angeles, California, United States

Site Status

Research Site

Tampa, Florida, United States

Site Status

Research Site

Rochester, Minnesota, United States

Site Status

Research Site

New York, New York, United States

Site Status

Research Site

Oklahoma City, Oklahoma, United States

Site Status

Research Site

Philadelphia, Pennsylvania, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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D6150C00001

Identifier Type: -

Identifier Source: org_study_id

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