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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

Phase
Phase 1
Sponsor
Mersana Therapeutics
Enrollment
162
Timeline
Jan 2023 → Apr 2027
About This Study

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

Eligibility Criteria

Inclusion Criteria

  • 1Participant 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.
  • 2Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • 3Participant must have measurable disease as defined by RECIST version 1.1.
  • 4Participant 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

  • 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.
  • 2Participant has received prior treatment targeting STING pathway.
  • 3Diagnosis 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.
  • 4Participants have untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis, or carcinomatous meningitis.
  • 5Participants are eligible if CNS metastases are adequately treated and participants are neurologically stable for at least 2 weeks prior to enrollment.
  • 6In addition, participants must be either off corticosteroids, or on a stable/decreasing dose of ≤ 10 mg prednisone daily (or equivalent).

Locations

14 sites participating in this study

Emory Healthcare, Emory Clinic

Atlanta, Georgia 30322

Recruiting

Manali Bhave, MD

University of South California

Los Angeles, California 90033

Recruiting

Anthony El-Khoueiry, MD

University of California Los Angeles

Los Angeles, California 90095

Recruiting

Nicholas McAndrew, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →