Brief Summary
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 advancedat a late stage, far along solid tumors.
Intervention / Treatment
- Drug: MDNA11
- Drug: Pembrolizumab (KEYTRUDA®)
Inclusion Criteria
- 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.