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
Sequential
AU-007
DrugMonoclonal Antibody Targeting IL-2
Aldesleukin
DrugIL-2
Avelumab
DrugMonoclonal Antibody Targeting PD-L1
Nivolumab
DrugMonoclonal Antibody Targeting PD-1
Evaluate the safety and tolerability of AU-007
Measured by the frequency of DLTs (Dose limiting toxicity) and safety profile
Establish the maximum tolerated dose (MTD) and/or RP2D
With AU-007 alone or in combination with aldesleukin measured by pharmacokinetics (PK), pharmacodynamics (PD), and Biomarkers
Magnitude of PK changes in the blood after dosing determined by area under the curve (AUC) of AU-007
The AUC of AU-007 will be measured at different timepoints after AU-007 administration
Magnitude of PK changes in the blood after dosing determined by maximum concentration (Cmax) of AU-007
The Cmax of AU-007 will be measured at different timepoints after AU-007 administration
Magnitude of PK changes in the blood after dosing determined by time of maximum concentration (Tmax)
The Tmax of AU-007 will be measured at different timepoints after AU-007 administration
Magnitude of PK changes in the blood after dosing determined by Half-life (T1/2) of AU-007
The T1/2 of AU-007 will be measured at different timepoints after AU-007 administration
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