A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination With Immune Checkpoint Inhibitor in Patients With Advanced Solid Tumors
A Phase 1/2 Open Label, Dose Escalation and Expansion Study of MDNA11, IL-2 Superkine, Administered Alone or in Combination with an Immune Checkpoint Inhibitor in Patients with Advanced Solid Tumors
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Clinical Trial Information
Trial Contact: Donaldson, Karin M; Grofsik, Kiera; Frankos, Marie; Djuro, Victor; Walton, Sherri
Trial Phone: 321.841.9821 ; 321.841.6626 ; 321.841.7303 ; 321.841.7477 ; 321.841.1907
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IRB No: 22.011.01
Protocol Abbrev: MDNA11-01
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase I
Age Group: Adult
Secondary Protocol No: ABILITY STUDY
Treatment: Drug: MDNA11 Monotherapy Drug: MDNA11 in combination with checkpoint inhibitor
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT05086692
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Objective
The aim of this study is to evaluate safety, tolerability, pharmacokinetic properties, pharmacodynamic effects, and preliminary anti-tumor activity of MDNA11 [both as a monotherapy and in combination with checkpoint inhibitor (pembrolizumab)] in patients with selected advanced solid tumors. Results from this study will be used to determine a recommended phase 2 dose (RP2D) and/or maximum tolerable dose (MTD) for MDNA11 and detect early signals of clinical activity in the single agent setting as well as in combination with pembrolizumab.
