An open label positron emission tomography (PET) imaging study using 89Zirconium to investigate the biodistribution of anti-HER3 monoclonal antibody (mAb) GSK2849330 and characterize its dose receptor occupancy relationship in subjects with advanced HER3-positive solid tumors
Completed
- Conditions
- tumorsadvanced solid tumors10027655
- Registration Number
- NL-OMON44283
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Quantitative parameters derived from PET-CT images to assess uptake in tumor<br /><br>tissue and normal tissues.<br /><br>• SUV (peak, mean) for each region of interest and Volume of region of interest</p><br>
- Secondary Outcome Measures
Name Time Method <p>• PET-CT images showing anatomical localization of radiolabel<br /><br>• Blood radioactivity concentration<br /><br>• PK parameters<br /><br>• Organ dose and total effective dose<br /><br>• Adverse events<br /><br>• Antibodies to GSK2849330 in serum</p><br>