Study on WTX-330 for Adults with Advanced or Metastatic Solid Tumors or Lymphoma

Inclusion Criteria

• Must be 18 years or older.
• For the first part of the study, patients must have advanced or metastatic solid tumors that have not responded to standard treatments or for which no standard treatment exists. Patients with certain types of prostate cancer or brain cancer are not eligible.
• For the second part of the study, patients must have advanced melanoma, colorectal cancer, or non-Hodgkin lymphoma that has not responded to standard treatments.
  • Group A: Patients with melanoma resistant to previous treatments.
  • Group B: Patients with colorectal cancer who have not had immunotherapy.
  • Group C: Patients with certain types of non-Hodgkin lymphoma who have had at least two previous treatments.
• Must be in good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Must have at least one measurable tumor.
• Must agree to have tumor biopsies before and during treatment.
• HIV-positive patients must be on treatment and have well-controlled disease.
• Must have adequate organ and bone marrow function.
• Must agree to use effective birth control during the study and for four months after the last dose.

Exclusion Criteria

• Have had another active cancer within the last two years, except for certain localized cancers.
• Have received previous treatment with IL-12.
• Have certain types of prostate or brain cancer.
• Have brain metastases requiring steroids.
• Have significant heart disease or abnormal heart tests.
• Have active autoimmune disease needing treatment in the last two years.
• Have a diagnosis of immunodeficiency or are on immunosuppressive therapy.
• Have had major surgery within two weeks before starting the study.
• Have received other cancer treatments recently.
• Have unresolved side effects from previous treatments.
• Have active infections, including hepatitis B, hepatitis C, or HIV with certain conditions.
• Are pregnant or breastfeeding.
• Have allergies to the study drug components.
• Have received a live vaccine recently.
• Have any condition that might interfere with the study or its results.