A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Solid Tumor
Unknown Primary
18 Years and older, Male and Female
MER-XMT-2056-1 (primary)
NCI-2022-11090
Summary
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
Objectives
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 biomarker data.
Eligibility
- 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 ineligible.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Participant must have measurable disease as defined by RECIST version 1.1.
- Participant has fresh tumor biopsy tissue available for submission to central laboratory. If obtaining fresh tumor tissue is medically contraindicated, archival tumor tissue can be submitted following written approval of the request by the study Medical Monitor. Samples must be obtained after the participant's most recent HER2-targeting therapy unless determined to be medically contraindicated after discussion with the medical monitor.
Treatment Sites in Georgia
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