tumors
Conditions
Interventions
Two doses 89Zr labeled GSK2849330 and unlabelled GSK2849330.
Sponsors
GlaxoSmithKline
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Males and females, 18 years and above. • Tumors with HER3 expression. • No standard therapeutic alternatives. • ECOG Performance Status 0-1. • Measurable disease suitable for PET imaging. • Females of childbearing potential: adequate method of contraception during study. • Men must use adequate contraception during study.
Exclusion criteria
Exclusion criteria: • Active central nervous system metastases. • Prior HER3- directed treatment. • Recent anti-cancer therapy or major surgery. • Allergic reaction to previous biological therapy. • Prohibited medications during study including immunesuppressants. • Significant CV risk, see protocol page 42 for details. • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Quantitative parameters derived from PET-CT images to assess uptake in tumor tissue and normal tissues. • SUV (peak, mean) for each region of interest and Volume of region of interest | — |
Secondary
| Measure | Time frame |
|---|---|
| • PET-CT images showing anatomical localization of radiolabel • Blood radioactivity concentration • PK parameters • Organ dose and total effective dose • Adverse events • Antibodies to GSK2849330 in serum | — |
Countries
Netherlands
Outcome results
None listed