Ipilimumab (Immunotherapy) and MGN1703 (TLR Agonist) in Patients With Advanced Solid Malignancies
NCT02668770 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28
Last updated 2026-04-07
Summary
The goal of this clinical research study is to find the highest tolerable dose of MGN1703 that can be given in combination with ipilimumab to patients with advanced tumors. The safety of this drug combination will also be studied.
This is an investigational study. MGN1703 is not FDA approved or commercially available. It is currently being used for research purposes only. Ipilimumab is FDA approved and commercially available for the treatment of unresectable (cannot be removed with surgery) or metastatic (has spread) melanoma.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
Conditions
Interventions
- DRUG
-
MGN1703
Dose Escalation Group Starting Dose: 15 mg on Days 1, 8, and 15 of each 21 day cycle. Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group.
- DRUG
-
Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle.
Sponsors & Collaborators
-
Mologen AG
collaborator INDUSTRY -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
David S. Hong, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-05-11
- Primary Completion
- 2025-11-05
- Completion
- 2025-11-05
- FDA Drug
- Yes
Countries
- United States
Study Locations
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