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A Phase 2, Multi-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of IPI-549 Administered in Combination with Front-line Treatment Regimens in Patients with Locally Advanced and/or Metastatic Triple-Negative Breast Cancer or Renal Cell Carcinoma
This is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC).
Primary Objectives: To evaluate the complete response (CR) rate per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1(1) following combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. Secondary Objectives: To evaluate the safety of combination treatment with IPI-549 and front-line treatment in patients with TNBC and RCC. To evaluate objective response rate (ORR), time to CR (TTCR), time to response (TTR), duration of CR (DOCR), duration of response (DOR), and progression-free survival (PFS) following combination treatment with IPI-549 and front-line treatment. To evaluate the pharmacokinetics (PK) of IPI-549 administered in combination with front-line treatment.