A PHASE 1 FIRST IN HUMAN DOSE ESCALATION AND EXPANSION MULTICENTER STUDY OF XMT- 2056 IN PARTICIPANTS WITH ADVANCED/RECURRENT SOLID TUMORS THAT EXPRESS HER2

Brief description of study

This study is designed for patients diagnosed with adanced/recurrent solid tumors expressing HER2.

This study is the first-in-human Phase 1, open-label study of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2. The XMT-2056 monotherapy trial will consist of dose escalation (DES) and expansion (EXP) parts. DES will be the dose-finding proportion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D).

The RP2D will be determined based on the totality of the clinical data, including safety and preliminary anti-tumor effect, PK, and relevant biomarker data. Upon determination of the RP2D observed in monotherapy, XMT-2056 in combination with other approved agents may be explored in the future.




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