RECRUITINGPhase 1INTERVENTIONAL
A Study of XMT-2056 in Advanced/Recurrent 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
About This Trial
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- • 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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).
Treatments Being Tested
DRUG
XMT-2056
XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)
Locations (14)
University of South California
Los Angeles, California, United States
University of California Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
AdventHealth Celebration
Celebration, Florida, United States
Emory Healthcare, Emory Clinic
Atlanta, Georgia, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
New York University Medical Oncology Associates
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States