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A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
NCT05514717 · Mersana Therapeutics
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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 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 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.
Exclusion Criteria:
* • Participant is receiving immunosuppressive doses of systemic medications, (doses \>10 mg/day prednisone or equivalent) that cannot be discontinued for at least 2 weeks before the first dose and during study drug treatment administration. Note: physiologic hormone replacement therapy is an exception.
* Participant has received prior treatment targeting STING pathway.
* Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within the last 2 years, expect for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the breast or the cervix. Participants with an additional malignancy that has a low risk for recurrence may be eligible after discussion with the study Medical Monitor.
* Participants have untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
1. Participants are eligible if CNS metastases are adequately treated and participants are neurologically stable for at least 2 weeks prior to enrollment.
2. In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).
Study design
Enrollment target: 162 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-01-24
Estimated completion: 2027-04
Last updated: 2025-07-11
Interventions
Drug: XMT-2056
Primary outcomes
- • Frequency of dose-limiting toxicities (DLTs) associated with XMT-2056 during the first cycle of treatment (Dose Escalation) (15 months)
- • Incidence of adverse events (Dose Escalation and Dose Expansion) (3 years)
- • Objective Response Rate (ORR) (Dose Expansion) (3 years)
Sponsor
Mersana Therapeutics · industry
Contacts & investigators
ContactJune Buchanan · contact · medicalinformation@mersana.com · 617-844-8613
InvestigatorBrad Sumrow, MD · study_director, Mersana Therapeutics
All locations (14)
University of South CaliforniaRecruiting
Los Angeles, California, United States
University of California Los AngelesRecruiting
Los Angeles, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
AdventHealth CelebrationRecruiting
Celebration, Florida, United States
Emory Healthcare, Emory ClinicRecruiting
Atlanta, Georgia, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
New York University Medical Oncology AssociatesRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
The Ohio State University Comprehensive Cancer CenterRecruiting
Columbus, Ohio, United States
Tennessee Oncology, PLLCRecruiting
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer CenterRecruiting
Houston, Texas, United States