This is a first in human, open-label, multi-center Phase 1 / 2 study to evaluate the safety, tolerability, and initial efficacy of AU-007, also known as imneskibart, in patients with advanced solid tumors. AU-007 will be administered either as a monotherapy, or in combination with a single loading dose of aldesleukin, or with both AU-007 and aldesleukin given every 2 weeks (Q2w). Once the recommended phase 2 dose (RP2D) of AU-007 plus aldesleukin was determined, (AU-007 Q2w plus a single loading dose of aldesleukin), AU-007 plus aldesleukin is also being administered with avelumab or nivolumab.
Patients must have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI
BRAF wild type: progressed after receiving PD-1 containing therapy with or without an anti-CTLA-4
BRAF mutation: patients who refused BRAF+MEK inhibitor
Must have objective progression after receiving at least two cycles of prior doublet therapy (anti-PD-1/anti-CTLA-4 or anti-PD-1/anti-LAG-3)
Patients with a history of known autoimmune disease with exceptions of
Vitiligo
Psoriasis, atopic dermatitis, or other autoimmune skin condition not requiring systemic treatment
History of Graves' disease in patients now euthyroid for > 4 weeks