Perlmutter Cancer Center

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Advanced/recurrent Solid Tumors That Express Her2
• Age: Between 18 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  In order to participate in this study the following criteria must be met:

  1. Participant must have HER2+ disease determined by institutional practice (e.g., IHC, ISH, or NGS). HER2 activating mutations or HER2 gene amplification are considered as qualifying for HER2+ disease for all participants. After dose escalation, 2 dose levels from DES will enroll additional participants to determine the RP2D of XMT-2056. HER2 low participants may be included in this enrollment. Participant must have fresh tumor biopsy tissue available for submission to central laboratory. If obtaining fresh tumor tissue is not medically feasible, 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 infeasible and is discussed with the medical monitor.
  2. Participant must have measurable disease as defined by RECIST version 1.1. Participant must have cardiac left ventricular ejection fraction (LVEF) =50% or = the institution’s lower limit of normal by either ECHO or MUGA scan.
  3. During the study, women of childbearing potential (WOCBP) must use a contraceptive method that is highly effective during study treatment and for at least 6 months after the last dose of study treatment. WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 72 hours before the first dose of study treatment. Testing may be done more frequently where required by local institutional guidelines or regulations, e.g., prior to administration of each dose. Male study participants must use barrier contraception (condoms) and refrain from donating sperm for the duration of study drug treatment and for at least 6 months after the last dose of study drug. Partners of male study participants considered to be WOCBP must use a highly effective contraceptive method for the same duration.

  
  

You may not be eligible for this study if the following are true:

• You will not be able to participate in this study if you have had:

  1. Participant has current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could interfere with per-protocol evaluations. Further, participants are excluded with the following characteristics: • A marked baseline prolongation of QT/QTcF interval CTCAE Grade >1: repeated demonstration of a QTcF interval > 450 milliseconds (ms) using Fridericia's QT correction formula. • A history of additional risk factors for Torsades de Pointes (e.g., family history of Long QT Syndrome).
  2. Diagnosis of additional malignancy that progressed or required active treatment within the last 2 years, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the breast or of the cervix or HBV/HCV. Participant has untreated hepatitis B virus (HBV) or hepatitis C virus (HCV). Negative serology for HBV and HCV is required during screening.
  3. 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. Participant has received prior treatment targeting STING pathway. Participant has either active or documented history of autoimmune disease that required systemic steroids or immunosuppressive medications within 1 year of starting study treatment, with the exception of treatment for vitiligo or resolved childhood asthma/atopy. Participant has had major surgery within 28 days before starting study treatment, systemic anticancer therapy within 28 days before starting study treatment, or palliative radiation therapy within 14 days of starting study treatment. Participant is receiving concurrent anti-cancer therapy (e.g., chemotherapy, radiation therapy, biologic therapy, immunotherapy, hormonal therapy, investigational therapy).