A Phase 1b/2 Multisite Dose-finding and Expansion Study of WTX-330 in Adult Patients With Selected Advanced or Metastatic Solid Tumors or Lymphoma

Exclusion Criteria

• •1. A history of another active malignancy (a second cancer) within the previous 2 years, except for localized cancers that are not related to the current cancer being treated, is considered cured, and, in the opinion of the Investigator, presents a low risk of recurrence. These exceptions include, but are not limited to, basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
• •2. Received prior treatment with IL-12 by any route of administration (including intratumoral injection).
• •3. Patients with primary CNS malignancies and CRPC
• •4. Have known symptomatic brain metastases requiring steroids.
• •5. Significant cardiovascular disease
• •6. Significant electrocardiogram (ECG) abnormalities
• •7. Active autoimmune disease requiring systemic treatment in the past 2 years
• •8. Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic systemic or enteric steroid therapy (dose \> 10 mg/day of prednisone or equivalent)
• •9. Major surgery (excluding placement of vascular access) within 2 weeks prior to the first dose of study drug.
• •10. Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine, or other anticancer herbal remedy) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug.
• •11. Radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
• •12. Any unresolved toxicities from prior therapy greater than National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia Grade 2 platinum therapy-related neuropathy and Grade 2 endocrine immune-related AEs managed with a stable dose of hormone replacement therapy.
• •13. Use of sensitive substrates of major CYP450 isozymes.
• •14. Any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent form (ICF), adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
• •15. Received a live vaccine within 30 days of the first dose of study drug.
• •16. Active systemic bacterial, viral, or fungal infection.
• •17. HIV-infected participants with a history of Kaposi sarcoma and/or multicentric Castleman Disease.
• •18. Active infection as determined by hepatitis B surface antigen and hepatitis B core antibody, or hepatitis B virus deoxyribonucleic acid (DNA) by quantitative polymerase chain reaction (qPCR) testing.
• •19. Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR testing.
• •20. Pregnant or lactating.
• •21. History of hypersensitivity to any of the study drug components.
• •22. Additional criteria may apply