Actively Recruiting
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
Led by Mersana Therapeutics · Updated on 2025-07-11
162
Participants Needed
14
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating XMT-2056, a new drug, in patients with advanced or recurrent solid tumors that express the HER2 protein. This Phase 1, first-in-human study is designed to assess the safety, tolerability, and preliminary anti-tumor effects of XMT-2056 in patients who have already received prior treatments. The study includes patients with various HER2-positive cancers, such as breast, gastric, non-small cell lung, and colorectal cancers, as well as HER2 low breast cancer. The study consists of two parts: dose escalation and dose expansion. During the dose escalation phase, researchers will find the highest dose of XMT-2056 that can be safely given and determine the recommended dose for further studies. XMT-2056 is given by intravenous infusion through a vein or port catheter. After this, the dose expansion phase will further evaluate safety and anti-tumor activity at the recommended dose. Treatment and assessments will continue throughout these phases. Participants will undergo tumor biopsies, physical exams, and laboratory tests, including blood sampling for drug levels and antibody analysis. Researchers will monitor side effects, tumor response, and drug behavior in the body over several years. The primary outcomes include measuring dose-limiting toxicities and adverse events, as well as the objective response rate to treatment. Participants will be closely followed to understand how XMT-2056 works and its safety profile during and after treatment.
CONDITIONS
Brief Title
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant has recurrent or metastatic solid tumors with HER2 expression and disease progression after treatment, intolerance, or contraindication to available anti-cancer therapies based on investigator judgment
- HER2 positivity confirmed by IHC 3+ or IHC 2+ combined with ISH+ tumor tissue testing
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Measurable disease as defined by RECIST version 1.1
- Availability of fresh tumor biopsy tissue for central lab submission, or archival tissue if fresh biopsy is medically contraindicated with approval
You will not qualify if you...
- Receiving immunosuppressive systemic medications above 10 mg/day prednisone or equivalent that cannot be stopped at least 2 weeks before and during study treatment (physiologic hormone replacement allowed)
- Prior treatment targeting the STING pathway
- Additional active malignancy requiring treatment within the last 2 years, except treated basal or squamous cell skin cancer or carcinoma in situ of breast or cervix
- Untreated central nervous system metastases, history of leptomeningeal metastasis, or carcinomatous meningitis
- CNS metastases must be adequately treated, neurologically stable for 2 weeks, and corticosteroid use must be stable or 10 mg prednisone daily or less
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive XMT-2056 administered intravenously to assess safety, tolerability, and preliminary anti-tumor effects.
1 visit per cycle (in-person)
Trial Site Locations
Total: 14 locations
1
University of South California
Los Angeles, California, United States, 90033
Actively Recruiting
2
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
3
Stanford University Medical Center
Stanford, California, United States, 94305
Actively Recruiting
4
AdventHealth Celebration
Celebration, Florida, United States, 34747
Actively Recruiting
5
Emory Healthcare, Emory Clinic
Atlanta, Georgia, United States, 30322
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
8
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
9
New York University Medical Oncology Associates
New York, New York, United States, 10016
Actively Recruiting
10
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
12
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43212
Actively Recruiting
13
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
14
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
June Buchanan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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