A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 Alone and in Combination with Nivolumab in Patients with Advanced Solid Tumors
Phase 1 (Dose-Escalation Phase) Objectives Primary: To define the safety profile, including DLT, and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and other safety parameters of BA3021 administered every 21 days in patients with advanced solid tumors. Secondary: To assess the pharmacokinetics (PK) of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Phase 2 (Dose-Expansion Phase) Objectives Primary: To assess antitumor activity of BA3021 in patients with specified tumor types. To assess the safety of BA3021. Secondary: To assess the PK of BA3021 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3021. Exploratory: To explore the relationship between tumor ROR2 status and clinical response to BA3021 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3021.
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