Conditions

Advanced Solid Tumors

Purpose of the study

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. NCT05086692  

Official Title

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.

Who is eligible to participate?

• Aged at least 18 years (inclusive at the time of informed consent). 

• Eastern Cooperative Oncology 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 screening and within 72 hours before the first dose 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. 

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane