drugset
drugset / Trial / NCT05086692

A Beta-only IL-2 ImmunoTherapY Study

NCT05086692 ↗

Phase 1/2 Recruiting 115 enrolled Medicenna Therapeutics, Inc. Merck Sharp & Dohme LLC · collab
NaSequentialOpen-labelTreatment

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 advanced solid tumors.

Timeline

Start
2021-08-27
Primary completion
2026-06-30
Completion
2026-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject MDNA11 Protein / enzyme biologic 0.003 mg/kg Intravenous
Subject MDNA11 Protein / enzyme biologic 0.6 mg/kg Intravenous
Subject Pembrolizumab Monoclonal antibody — Intravenous

Indications

acral lentiginous melanoma cervical cancer clear cell renal carcinoma colorectal cancer cutaneous neuroendocrine carcinoma endometrial carcinoma esophageal cancer fallopian tube cancer gastric cancer gastroesophageal cancer head and neck squamous cell carcinoma malignant epithelial tumor of ovary malignant pleural mesothelioma mucosal melanoma non-small cell squamous lung carcinoma pancreatic adenocarcinoma primary peritoneal carcinoma skin basal cell carcinoma skin squamous cell carcinoma triple-negative breast carcinoma urinary bladder cancer