A Phase 1 First in human Dose Escalation and Expansion Multicenter Study of XMT-1660 in Participants with Solid Tumors

Brief description of study

The proposed first-in-human study of XMT-1660 will be a Phase 1, open-label trial of XMT-1660 in previously treated participants with metastatic TNBC, HR+/HER2- or HER2+ breast cancer, endometrial cancer, or ovarian, fallopian tube, or primary peritoneal cancer. The study is composed of 2 parts: a dose escalation part (DES) and an expansion (EXP) part. The DES part of the study will be the dose finding cohort to assess tolerability and safety of XMT-1660 and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D). The EXP part of the study will further evaluate the preliminary efficacy and safety of XMT-1660 at the MTD and/or RP2D in participants with advanced/metastatic (1) TNBC; (2) HR+/HER2- breast cancer; and (3) endometrial or ovarian, fallopian tube, or primary peritoneal cancer.


Clinical Study Identifier: s22-00389
ClinicalTrials.gov Identifier: NCT05377996
Principal Investigator: Nancy Chan.
Other Investigators: Yelena Novik, Maryann J Kwa, Christina Grace Wilson, Leslie R Boyd, Marleen I Meyers, Marina Stasenko, Michelle Diane Swanson Lightfoot, Erin Annette Reese, Douglas K Marks, Caitlin Elizabeth Ryan, Ruth Oratz, Natalie Jill Klar, Gregory Edward Totero, Bhavana Pothuri, Whitfield B. Growdon, Kathleen M Lutz.


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