64-Cu Labeled Brain PET/MRI for MM-302 in Advanced HER2+ Cancers With Brain Mets
Status:
Withdrawn
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
Summary
This is a single arm pilot study of 64Cu-MM-302 and unlabeled MM-302 in combination with
trastuzumab in 10 patients with advanced HER2+ cancer with new or progressive brain
metastases. Patients will receive standard imaging at baseline, including FDG-PET/CT plus MR
brain imaging. Patients will subsequently start protocol therapy with MM-302 and trastuzumab
given on day 1 of an every 21-day dosing cycle, at the recommended phase 2 dose of 30 mg/m2.
Patients will receive 64Cu-labeled MM-302 (3-5 mg/m2 doxorubicin) three hours after unlabeled
dose of MM-302. Integrated MR/PET imaging of the brain and whole body will be performed at
two time points following 64Cu-labeled MM-302 administration: (1) within 3 hours (+/- 1 hour)
of labeled drug injection, and (2) 24 hours (+/- 6 hours) post-injection. Patients will
continue to receive subsequent doses of unlabeled MM-302 plus trastuzumab every 3 weeks until
clinical or radiographic disease progression (either in the brain or systemically) or
unacceptable toxicity, whichever occurs soonest. MR brain imaging and FDG-PET/CT scans will
be performed every 9 weeks to monitor for treatment response and disease progression.
Phase:
Early Phase 1
Details
Lead Sponsor:
Pamela Munster University of California, San Francisco