Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma

IPI-549 is an oral, selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma). It is an orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day to patients in both cohorts A and B depending on the results of the safety run-in phase for each cohort.

Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). 840 mg of the drug will be administered intravenously (IV) on days 1 and 15 in combination of each 28-day cycle for patients with TNBC. 1200mg will be administered IV on day 1 of each 21-day cycle to patients with RCC.

Nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel (Taxol), a mitotic inhibitor chemotherapy, with less toxicity than solvent-based (sb) paclitaxel and achieves a 33% higher tumor uptake in preclinical models. Nab-paclitaxel will be administered intravenously (IV) at 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle for patients with TNBC.

Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) recombinant monoclonal antibody that is approved by the FDA for the treatment of multiple solid tumors in combination with chemotherapy. It will be administered at 15 mg/kg IV on day 1 of each 21-day cycle to patients with RCC.