Education and Training
A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2
A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: XMT-2056
Eligibility
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).
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Feriel Buchholz
650-721-4090
Not Recruiting