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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

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