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PSCI 21-148 A 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

This is a Phase 1, first-in-human open-label, dose-escalation and expansion study, evaluating the safety, tolerability, PK, preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination with atezolizumab, and in combination with avelumab to subjects with advanced solid tumors.
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Cytologically or histologically confirmed solid tumor that is inoperable, locally advanced, metastatic, or recurrent:
Subjects with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective.
Subjects with metastatic CRPC (adenocarcinoma of the prostate). Neuroendocrine differentiation and other features permitted if adenocarcinoma is the primary histology.
Exclusion Criteria:
Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment
Prior treatment with XL092 (all cohorts), prior treatment with PD-L1/PD-1 targeting immune checkpoint inhibitor
Receipt of any type of anticancer antibody (including investigational antibody), systemic chemotherapy, or hormonal anticancer therapy.
Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
Kidney & Urinary System
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Hershey, PA