This is a Phase 1 and 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.
Advanced Solid Tumors:
Unresectable Solid Tumor
Clear Cell Renal Cell Carcinoma
Triple Negative Breast Cancer
Non-Small Cell Lung Cancer Squamous
Non-Small Cell Lung Cancer Non-squamous
Colorectal Cancer (MSI-H)
Basal Cell Carcinoma
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma
Solid Tumor, Adult
MSI-H Solid Malignant Tumor
Cancer With A High Tumor Mutational Burden
Epithelial Ovarian Carcinoma
Primary Peritoneal Cancer
Gastroesophageal Junction (GEJ) Cancer
DMMR Solid Malignant Tumor
Fallopian Tube Cancer
Approximately 115 patients will be enrolled.
Inclusions/Exclusions: Aged at least 18 years (inclusive at the time of informed consent). Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1. Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study must be discussed on a case-by-case basis with the MM for approval.