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A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients with Advanced Solid Tumors
The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors.
Phase 1 (Dose-Escalation Phase) Objectives: Primary: To define the safety profile, including dose limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), of BA3011 administered every 21 days in patients with advanced solid tumors. Ssecondary: To assess the safety of BA3011. To assess the pharmacokinetics (PK) of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Phase 2 (Dose-Expansion Phase) Objectives: Primary: To assess antitumor activity of BA3011 in patients with specified tumor types. To assess the safety of BA3011. Secondary: To assess the PK of BA3011 in patients with advanced solid tumors. To evaluate the immunogenicity of BA3011. Exploratory: To explore the relationship between tumor AXL status and clinical response to BA3011 in patients with specified tumors. To evaluate potential candidate tumor and blood-based biomarkers for patient selection or correlation with antitumor activity of BA3011.