A Beta-only IL-2 Immunotherapy Study (ABILITY-1)

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)
Gastric Cancer
Cervical Cancer
Basal Cell Carcinoma
Bladder Cancer
Merkel Cell Carcinoma
Squamous Cell Carcinoma of Head and Neck
Cutaneous Squamous Cell Carcinoma
Pleural Mesothelioma
Esophageal Cancer
Hepatocellular Carcinoma
Endometrial Carcinoma
Solid Tumor
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
Acral Melanoma
Mucosal Melanoma
Cutaneous Melanoma
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.

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