STELLAR-001: This phase I study is evaluating how safe, tolerable and effective a new drug (XL092) is alone, or combined with immunotherapy (Atezolizumab or Avelumab) in people with inoperable, locally advanced or metastatic solid cancersA Dose-Escalation and Expansion Study of the Safety and Pharmacokinetics of XL092 as Single-Agent and Combination Therapy in Subjects With Inoperable Locally Advanced or Metastatic Solid Tumors

Summary

This is a dose escalation and cohort expansion study assessing XL092 alone, in combination with Atezolizumab, and in combination with Avelumab. In Experimental Arm 1, XL092 Single-Agent Dose-Escalation, participants will accrue in cohorts of 3-6 in a standard 3+3 design, and will receive oral doses of XL092. In Experimental Arm 2, XL092 Single-Agent Expansion Cohort, the maximum tolerated dose (MTD) or recommended dose of XL092 from the dose-escalation stage (Arm 1) may be further explored in clear cell renal cell carcinoma (ccRCC), non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), and metastatic castration-resistant prostate cancer (mMRPC). In Experimental Arm 3, XL092 + Atezolizumab Dose-Escalation, participants will accrue in cohorts of 2-6 in a "rolling 6" design. Participants will receive oral doses of XL092 in combination with Atezolizumab, administered as a 1200mg intravenous (IV) infusion once every 3 weeks. In Experimental Arm 4, XL092 + Atezolizumab Expansion, the MTD or recommended dose of XL092 from the dose-escalation stage (Arm 3) may be further explored in non-clear cell renal cell carcinoma (nccRCC), hormone receptor-positive breast cancer (HR+ BC), metastatic castration-resistant prostate cancer (mCRPC), and colorectal cancer (CRC). Atezolizumab will be administered the same as in Arm 3. In Experimental Arm 5, XL092 + Avelumab Dose-Expansion, participants will accrue in cohorts of 2-6 in a "rolling 6" design. Participants will receive XL092 in combination with Avelumab, administered as an 800mg IV infusion once every 2 weeks. In Experimental Arm 6, XL092 + Avelumab Expansion, the MTD or recommended dose of XL092 from the dose-escalation stage (Arm 5) may be further explored in advanced urothelial carcinoma (UC). Avelumab will be administered the same as in Arm 5.