Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients (CAM-VHH1)
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|ClinicalTrials.gov Identifier: NCT02683083|
Recruitment Status : Completed
First Posted : February 17, 2016
Results First Posted : July 18, 2019
Last Update Posted : August 7, 2019
Primary purpose of the clinical study is to evaluate the safety, biodistribution and radiation dosimetry of [131I]-SGMIB Anti-HER2 VHH1 in healthy volunteers and patients with HER2+ breast cancer.
Secondary purpose of the clinical study is to evaluate the tumor uptake of [131I]-SGMIB Anti-HER2 VHH1 in patients with HER2+ breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers Breast Cancer||Biological: [131I]-SGMIB Anti-HER2 VHH1||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study to Evaluate the Safety, Biodistribution, Radiation Dosimetry and Tumor Imaging Potential of [131I]-SGMIB Anti-HER2 VHH1 in Healthy Volunteers and Breast Cancer Patients: CAM-VHH1 Study|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||February 5, 2018|
|Actual Study Completion Date :||February 5, 2018|
|Experimental: [131I]-SGMIB Anti-HER2 VHH1||
Biological: [131I]-SGMIB Anti-HER2 VHH1
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: 1 day ]
- The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan [ Time Frame: 1 day ]Cancer lesions above 3 cm will be visually interpreted by an experienced nuclear medicine physician. Lesions will be scored positive if CAM-H2 uptake in the lesion is higher than surrounding background.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683083
|Brussels, Choose A State, Belgium, 1090|