A Study of AIP-303 in HER2 Positive Breast Cancer and/or Metastatic Breast Cancer Patients

Summary

Participation Requirements

Description

This is a prospective, Phase I/II, multi-center, open-label study in a total of 150 subjects with HER2 Positive Breast cancer tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 ...

This is a prospective, Phase I/II, multi-center, open-label study in a total of 150 subjects with HER2 Positive Breast cancer tumors. Eligible participants will undergo baseline assessments at enrollment. Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 weeks apart and a CT scan immediately after. An AIP 301 Ga-68 PET/CT scan will be performed four weeks before and four weeks after the initial dose of the AIP-303. An IEC will review the protocol and any amendments and advertisements used for recruitment. The IEC will review the patient information sheet and the informed consent form, their updates (if any), and any written materials given to the patients. A list of all IECs to which the protocol has been submitted and the name of the committee chairmen will be included in the clinical trial report.

Tracking Information