Trial Outcomes & Findings for 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 (NCT NCT02683083)

NCT ID: NCT02683083

Last Updated: 2019-08-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 9 participants
• Primary outcome timeframe: 1 day
• Results posted on: 2019-08-07

Participant Flow

Participant milestones

Measure	[131I]-SGMIB Anti-HER2 VHH1 All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1).
Overall Study STARTED	9
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	[131I]-SGMIB Anti-HER2 VHH1 n=9 Participants All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1).
Age, Continuous	39.78 years STANDARD_DEVIATION 18.97 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Outcome measures

Measure	[131I]-SGMIB Anti-HER2 VHH1 n=9 Participants All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1).
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	[131I]-SGMIB Anti-HER2 VHH1 n=3 Participants All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1).
The Tumor Targeting Potential Will be Visually Scored on the Planar Total Body Scan	2 Participants

Adverse Events

[131I]-SGMIB Anti-HER2 VHH1

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	[131I]-SGMIB Anti-HER2 VHH1 n=9 participants at risk All subjects received one single intravenous injection of the investigational medical product (\[131I\]-SGMIB Anti-HER2 VHH1).
Gastrointestinal disorders Abdominal discomfort	11.1% 1/9 • Number of events 1 • 1 day
Skin and subcutaneous tissue disorders Adhesive plaster sensitivity	11.1% 1/9 • Number of events 1 • 1 day
Skin and subcutaneous tissue disorders Ecchymosis	22.2% 2/9 • Number of events 2 • 1 day

Additional Information

Tony Lahoutte

Camel-IDS

Phone: 0032 24799360

Email: tony.lahoutte@camel-ids.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place