Dose-escalation Study to Assess Safety, Tolerability and Pharmacokinetics of MEDI-573 in Japanese Subjects

A Phase 1, Open-label, Single-arm, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-573, a Fully Human Monoclonal Antibody Directed Against Insulin-like Growth Factors I and II, in Japanese Subjects With Advanced Solid Tumours Refractory to Standard Therapy or for Which No Standard Therapy Exists

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01340040

Enrollment

Registered

2011-04-21

Start date

2011-07-31

Completion date

2012-05-31

Last updated

2014-12-11

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

Conditions

Advanced Solid Malignancies, Cancer

Keywords

Phase I, cancer, solid tumours, advanced solid malignancies, dose escalation, Insulin like growth factor, Japanese

Brief summary

The primary purpose of this study is to explore the safety and tolerability of MEDI-573 in Japanese subjects with advanced solid tumours refractory to standard therapy or for which no standard therapy exists.

Interventions

DRUGMEDI-573

MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Japanese men or women at least 20 years of age * Histological or cytological confirmation of a solid, malignant tumour excluding lymphoma that is refractory to standard therapies or for which no standard therapies exist * WHO performance status 0-2 with no deterioration over the previous 2 weeks

Exclusion criteria

* Previous therapy with medication against IGF (ie, monoclonal antibodies with IGF-1R or IGF-targeting tyrosine kinase inhibitors) * Inadequate bone marrow reserve or organ function * Poorly controlled diabetes mellitus as defined by the investigator's assessment and/or glycosylated hemoglobin (HbA1c) reading \> 6.5% within 28 days prior to the first dose of MEDI-573 * History of allergy or reaction to any component of the MEDI-573 formulation or drugs with a similar chemical structure or class to MEDI-573

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events (based on CTCAE version 4.0), laboratory values, vital sign measurements, ECG, Physical Examination	All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Secondary

Measure	Time frame	Description
Anti-tumor activity of MEDI-573 using Response Evaluation Criteria in Solid Tumors(RECIST)	Tumor assessment by RECIST 1.1 every 2 cycles	subjects who discontinue the study treatment for reasons other than disease progression or initiation of alternative anticancer therapy will undergo tumor assessment 3 months after the last dose of MEDI-573). The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics, - Cmax	For Cohorts 1, 2 and 3:Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics,- Cmax at steady state (Cmax, ss)	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - time to maximum concentration (tmax)	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Immunogenicity of MEDI-573 (by measuring anti-MEDI-573 antibodies)	For Cohorts 1, 2 and 3:day 1 (pre-dose) of every cycle; 30 days after the last dose; 3 months after the last dose	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - (AUC(0-t))	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics - total clearance and terminal phase (Vz) of MEDI-573	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacodynamics: - Insulin-like growth factor (IGF)-I and IGF-II on circulating plasma levels of MEDI-573	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
Pharmacokinetics, - terminal elimination rate constant (λz)	For Cohorts 1, 2 and 3: Multiple timepoints taken, begining at Day 1 and until 30 days after last dose.	The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026