Phase I study of MEDI0680 (AMP-514) in Advanced Malignancies
A Phase 1, Open-label Study to Evaluate the Safety and Tolerability of MEDI0680 (AMP-514) in Combination with MEDI4736 in Subjects with Advanced Malignancies
The primary purpose of this research study is to determine how safe and tolerable MEDI0680 (AMP-514) and MEDI4736 are when given together in subjects with advanced cancers. MEDI0680 (AMP-514) and MEDI4736 are monoclonal antibodies that may prevent cancer growth and help the immune system eliminate the tumor. The idea behind developing these types of experimental drugs is that stimulating the immune system could be a different way of killing cancer cells, and by administering both antibodies, an important pathway can be targeted that may help your immune system eliminate tumors. The information learned from this study may be helpful in further development of MEDI0680 (AMP-514) and MEDI4736 for the treatment of cancer.
Are you Eligible? (Inclusion Criteria)
A Phase 1 study initially enrolling immunotherapy naive patients (18 years or older) with advanced solid tumor cancers to determine the maximum tolerated dose (dose escalation phase) for the combination. Advanced solid tumor patients with prior immunotherapy exposure will be recruited for the dose escalation phase once the maximum tolerated dose has been determined. Patients with hematologic malignancies who are immunotherapy naive will be recruited once the maximum tolerated dose has been determined for the immunotherapy naive solid tumor patients. Patients with prior immunotherapy exposure and immunotherapy naive will be recruited to the Dose Expansion phase.