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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.).
- Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening and within 72 hours before the first dosethe amount of medication taken 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.