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
Mersana Therapeutics
Summary
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
Description
The first-in-human (FIH) study of XMT-2056 is 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 portion 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 biom…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participant has recurrent or metastatic solid tumors with HER2 expression and has disease progression after treatment, is intolerant to treatment, or is contraindicated with available anti-cancer therapies known to confer benefit, based on investigator's judgement. Note: Participants must have HER2 positivity per the results of their most recent tumor tissue testing, defined as IHC 3+ or IHC 2+ in combination with in situ hybridization (ISH)+. Participants with ERBB2-activating mutations or ERBB2 gene amplification in the absence of HER2 positivity are considered ineligi…
Interventions
- DrugXMT-2056
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
Locations (14)
- University of South CaliforniaLos Angeles, California
- University of California Los AngelesLos Angeles, California
- Stanford University Medical CenterStanford, California
- AdventHealth CelebrationCelebration, Florida
- Emory Healthcare, Emory ClinicAtlanta, Georgia
- Massachusetts General HospitalBoston, Massachusetts