About the study
A Phase 1/2, Multicentre, Open-Label Study of Modi-1 in patients with head and neck cancer, renal cancer, and triple negative breast cancer
The study proposes a trial of a new vaccine, Modi-1, that consists of a combination of specific peptides. The Modi-1 peptides are combined with an adjuvant, which is designed to increase the activity of the vaccine.
The aim of this study is to investigate the safety and effectiveness of the Modi-1 vaccine(s) in participants with head and neck cancer, renal cancer, and triple negative breast cancer.
In this trial, Modi-1 will be administered, either on its own (monotherapy) or in combination with a Checkpoint Inhibitor (which is given as standard of care).
In addition, a randomized cohort is included in this study. This cohort is available to patients with head and neck cancer who are scheduled to have their tumour removed, intending to cure their cancer. In this cohort the local impact of Modi-1 (with or without pembrolizumab) will be assessed by looking at the removed tumour.
Modi-1 will be administered intradermally (just under the top layer of skin). The MicronJet600™ micro-needle device will be used to administer the vaccine and contains three very small needles.
Locations
Information about the ModiFY Study
Sample size
How many patients will be included?
Up to 138 patients
Investigational Product
What drug are we testing?
Modi-1 vaccine
Study Sponsor
Scancell Ltd
Scancell is focused on developing novel immunotherapies for the treatment of cancer and infectious disease
Study Design
A Phase 1/2 study to assess the safety, tolerability (if there are any side effects, are they bearable?), immunological activity (does it trigger the bodies immune systems defences?) and preliminary efficacy (how well does it work?) of the Modi-1 vaccine in patients with head and neck cancer, renal cancer, and triple negative breast cancer
Primary outcomes
What is the study Measuring?
- Does Modi-1 trigger an immune response?
- Safety of Modi-1: The number of Modi-1 related side effects
Study Population
What types of cancer is this study targeting?
1. Head and Neck Cancer
2. Renal Cancer
3. Triple Negative Breast Cancer
Study Team
Christian Ottensmeier
Chief Investigator
Christian is a medical oncologist with a sub-specialty in thoracic malignancies, skin cancer, and immunotherapy.
Fayaz Master
Head of Clinical Operations at Scancell
Fayaz has over 20 years of clinical operations experience in early and late-stage global oncology clinical development.
Robert Miller
Medical Director at Scancell
Robert has over 32 years of experience in drug development. He is a Fellow of the Royal College of Surgeons and Fellow of the Faculty of Pharmaceutical Medicine and Royal Society of Medicine.
Joe Thornton
Clinical Project Manager
Joe has over 6 years of clinical operations experience in early and late-stage global oncology clinical development.