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

The proposed first-in-human study of XMT-2056 will be a 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 agent(s) may be explored (see Section 2.4.2 and Section 4.1.2) and will be specified in a future amendment.


Clinical Study Identifier: s22-00338
ClinicalTrials.gov Identifier: NCT05514717
Principal Investigator: Kristen Spencer.
Other Investigators: Nila Theresa De La Rosa, Scot Niglio, Samantha VanMaanen, Carol M Lee, Salman Rafi Punekar, Jessica Wang, Kathleen M Madden, Elaine Shum, Jeffrey S. Weber, Jonathan B Kahn, Joshua K Sabari, Keriann M Scavone, Cosmin Adrian Tegla, Kirby Rodriguez, Nina Beri, Nancy Chan, David R. Wise, Eneil De La Pena, Janice Mehnert, Douglas K Marks.


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