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A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b
This is a multi-center study of XMT-1536 in patients with tumors likely to express NaPi2b.
Primary in Dose Escalation (DES): Determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of XMT-1536 administered intravenously once every four weeks Assess the safety and tolerability of XMT-1536 Primary in Expansion (EXP): Assess further the safety and tolerability of XMT-1536 administered at the MTD/RP2D identified in the DES Assess the preliminary anti-neoplastic activity of XMT-1536 Secondary in DES: Assess the preliminary anti-neoplastic activity of XMT-1536 Secondary in DES and EXP: Assess the pharmacokinetics (PK) of XMT-1536, its release product, and selected metabolites Assess the development of anti-drug antibodies to XMT-1536 Assess the association of tumor expression of NaPi2b and objective tumor response to XMT-1536 Assess safety and efficacy in ovarian cancer subpopulations, including patients previously treated and failed therapy with bevacizumab and patients with and without BRCA mutation who were previously treated and failed therapy with PARP inhibitors Exploratory in DES and EXP: Retrospectively evaluate the association of objective response with tumor expression of genes other than NaPi2b, or other tumor molecular and histologic features