RECRUITING

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

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Conditions

HER2-positive Breast CancerHER2-positive Gastric CancerHER2-positive Non-Small Cell Lung CancerHER2-positive Colorectal CancerHER2-positive TumorsHER2 Low Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

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

Quick Facts

Study Start:2023-01-24
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05514717

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  3. * Participant must have measurable disease as defined by RECIST version 1.1.
  4. * 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.
  1. * • 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.
  2. * Participant has received prior treatment targeting STING pathway.
  3. * 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.
  4. * Participants have untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
  5. 1. Participants are eligible if CNS metastases are adequately treated and participants are neurologically stable for at least 2 weeks prior to enrollment.
  6. 2. In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).

Contacts and Locations

Study Contact

June Buchanan
CONTACT
617-844-8613
medicalinformation@mersana.com

Principal Investigator

Brad Sumrow, MD
STUDY_DIRECTOR
Mersana Therapeutics

Study Locations (Sites)

University of South California
Los Angeles, California, 90033
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
New York University Medical Oncology Associates
New York, New York, 10016
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Mersana Therapeutics

  • Brad Sumrow, MD, STUDY_DIRECTOR, Mersana Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-24
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-01-24
Study Completion Date2027-04

Terms related to this study

Additional Relevant MeSH Terms

  • 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