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Recruiting Phase 1 NCT05514717

NCT05514717 A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

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Clinical Trial Summary
NCT ID NCT05514717
Status Recruiting
Phase Phase 1
Sponsor Mersana Therapeutics
Condition HER2-positive Breast Cancer
Study Type INTERVENTIONAL
Enrollment 162 participants
Start Date 2023-01-24
Primary Completion 2027-04

Trial Parameters

Condition HER2-positive Breast Cancer
Sponsor Mersana Therapeutics
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 162
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-01-24
Completion 2027-04
Interventions
XMT-2056

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Brief Summary

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.

Eligibility Criteria

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 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

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