A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors
This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.
• Aged at least 18 years (inclusive at the time of informed consent).
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
• Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
• Demonstrated adequate organ function
• Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
• Life expectancy of ≥ 12 weeks.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
• Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.