This study is investigating how safe, tolerable and effective a new treatment (called DF6215) is in people with advanced solid cancersA Phase 1/1b, First-In-Human, Multi-Part, Open-Label Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of DF6215 in Patients With Advanced (Unresectable, Recurrent, or Metastatic) Solid Tumors

Exclusion

Key Exclusion Criteria - General (applies to all cohorts)

• Patients receiving chemotherapy, radiotherapy (other than palliative bone-directed radiotherapy), major surgery, or receiving another therapeutic agent within 28 days before the start of study drug or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter

• Concurrent anticancer treatment (eg, cytoreductive therapy, radiotherapy [except for palliative bone-directed radiotherapy], immune therapy, or cytokine therapy [except for erythropoietin]), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of treatment or within 5 half-lives of the previous therapeutic agent (if known), whichever is shorter. Short-term administration of systemic steroids (eg, for allergic reactions or the management of immune-related adverse events [irAEs]) is allowed.

  • Note: Patients receiving bisphosphonate or denosumab are eligible, provided treatment was initiated at least 14 days before the first dose of DF6215
• Previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, low-grade prostate cancer (Gleason score ≤ 6 and must be Stage I or II), or cervical carcinoma in situ
• Life expectancy of less than 3 months

• Patients with brain metastases are excluded, unless all of the following criteria are met:

  • Central nervous system (CNS) lesions are asymptomatic and previously treated
  • Patient does not require ongoing daily steroid treatment for replacement for adrenal insufficiency (except ≤ 10 mg prednisone [or equivalent])
  • Imaging demonstrates stable disease 28 days after last treatment
• Receipt of any organ transplant, including autologous or allogeneic stem-cell transplantation
• Pregnancy or lactation during the study