Testing XMT-2056 for advanced solid tumors that express HER2

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

This study is testing a new drug called XMT-2056 to see if it can safely help people with advanced solid tumors that have HER2 and who have already been treated.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mersana Therapeutics (Industry-sponsored)
• Drugs / interventions: radiation, prednisone
• Locations: 14 sites (Los Angeles, California and 13 other locations)
• Trial ID: NCT05514717 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label study evaluates the safety and tolerability of XMT-2056 in patients with advanced or recurrent solid tumors that express HER2. The trial includes a dose escalation phase to determine the maximum tolerated dose and a dose expansion phase to assess preliminary anti-tumor effects. Participants must have previously treated HER2-positive tumors and measurable disease. The study aims to gather data on the drug's pharmacokinetics and relevant biomarkers.

Who should consider this trial

Good fit: Ideal candidates are patients with recurrent or metastatic solid tumors expressing HER2 who have progressed after prior treatments.

Not a fit: Patients with HER2-negative tumors or those who have not progressed after standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HER2-positive advanced solid tumors.

How similar studies have performed: Other studies targeting HER2-positive tumors have shown promising results, indicating potential for success with this approach.

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).

Where this trial is running

Los Angeles, California and 13 other locations

• University of South California — Los Angeles, California, United States (Recruiting)
• University of California Los Angeles — Los Angeles, California, United States (Recruiting)
• Stanford University Medical Center — Stanford, California, United States (Recruiting)
• AdventHealth Celebration — Celebration, Florida, United States (Recruiting)
• Emory Healthcare, Emory Clinic — Atlanta, Georgia, United States (Recruiting)
• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
• Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
• Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
• New York University Medical Oncology Associates — New York, New York, United States (Recruiting)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• The Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States (Recruiting)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Study coordinator: June Buchanan

Conditions HER2-positive Breast Cancer; HER2-positive Gastric Cancer; HER2-positive Non-Small Cell Lung Cancer; HER2-positive Colorectal Cancer; HER2-positive Tumors; HER2 Low Breast Cancer