A Study of MEDI-575 in Patients With Advanced Solid Malignancies

A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01102400

Enrollment

Registered

2010-04-13

Start date

2010-03-31

Completion date

2012-11-30

Last updated

2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Solid Malignancies

Keywords

cancer, tumor, hepatocellular carcinoma

Brief summary

The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).

Interventions

DRUGMEDI-575

MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Having advanced solid malignancy for which no curative or standard therapies exist * Karnofsky performance status of ≥60 * Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)

Exclusion criteria

* Inadequate bone marrow reserve or organ function * Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures * History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody

Design outcomes

Primary

Measure	Time frame
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign	30 days after the last dose of MEDI-575

Secondary

Measure	Time frame
Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion	30 days after last dose of study drug
To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies	3 months after last dose of study drug
Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)	3 months after last dose of study drug

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026