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 (ABILITY-1 STUDY)
Clinical Trial Information
Trial Contact: Donaldson, Karin M; Frankos, Marie; Djuro, Victor
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
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.
Key Inclusion Criteria:
1. Aged at least 18 years (inclusive at the time of informed consent).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
3. 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.
4. Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
5. Demonstrated adequate organ function
6. Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
7. Life expectancy of ≥ 12 weeks.
8. 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.
9. Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control.