To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
NCT ID:
NCT05514717
Condition:
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
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
XMT-2056
Description:
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
Arm group label:
XMT-2056
Summary:
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
Detailed description:
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of South California
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anthony El-Khoueiry, MD
Facility:
Name:
Stanford University Medical Center
Address:
City:
Stanford
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher Chen, MD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samuel Klempner, MD
Facility:
Name:
New York University Medical Oncology Associates
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kristen Spencer, MD
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Claire Friedman, MD
Facility:
Name:
Tennessee Oncology, PLLC
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Contact:
Last name:
Erika P Hamilton, MD
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ecaterina Dumbrava, MD
Start date:
January 24, 2023
Completion date:
April 2027
Lead sponsor:
Agency:
Mersana Therapeutics
Agency class:
Industry
Source:
Mersana Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05514717