Phase I Clinical Trials Program
Our solid tumour Phase I program is the largest early phase cancer clinical trial program in Canada and is one of the top-rated programs of its kind worldwide. The program conducts investigator-initiated early-phase clinical trials and correlative studies with novel anti-cancer agents or combinations, including novel immuno-oncology drugs. Since its creation, the Phase I program has steadily enrolled about 250-270 solid tumour patients a year, offering many Canadian patients the opportunity to enrol on new anticancer drug studies without having to travel abroad.
The Phase I team includes 5 staff medical oncologists (Dr. Lillian Siu, Dr. Philippe Bedard, Dr. Albiruni Razak, Dr. Aaron Hansen, and Dr. Anna Spreafico), 4-6 clinical research fellows, 6 dedicated research nurses, 2 pharmacokinetic nurses, 1 investigational drug pharmacist, 1 program manager, 2 assistant program managers, 1 clinical trial specialist, 1 tissue coordinator for trial screening, 12 clinical study coordinators, 2 regulatory coordinators, 1 financial analyst and 1 grants and contracts specialist. In addition, the Phase I Program is operationally supported by the Correlative Science Program which handles, processes and ships biological samples collected in clinical trials. The Phase I Unit at the Princess Margaret Cancer Centre includes six inpatients beds for monitoring, seven outpatient assessment beds, and a designated room equipped for pharmacokinetic sample processing and storage.
Since 2008, the Phase I program continues to be supported by an award from the United States National Cancer Institute and is one of thirteen Consortia members of the Experimental Therapeutics Clinical Trials Network (ETCTN). Based on the high calibre of research the group is conducting, major pharmaceutical companies such as Novartis, BMS, Merck, GSK, Pfizer and Genentech/Roche have selected the program as a preferred partner. The Phase I program is known for its efficiency in activating new clinical trials. In 2017, it took an average of 66 days for the Phase I program to activate 18 new clinical trials and to enrol its first patients into these new trials after submission to the Institutional Review Board for regulatory approval.
The Phase I program is known for its expertise in conducting first-in-human clinical trials. In 2018, the types of novel anticancer agents evaluated by the Phase I program includes:
- Immune checkpoint inhibitors beyond anti-CTLA-4 and anti-PD1/L1 antibodies
- Co-stimulatory molecules
- Functional modification of immuno-suppressive enzymes
- Myeloid cell modulation
- Personalized cancer vaccines
- T cell bispecific antibodies
- Adoptive cell therapy
- Oncolytic viruses
- Intratumoural immunotherapy
- Novel molecularly targeted therapy
- Chemotherapy, radiotherapy or targeted therapy in combination with immunotherapy
Drug Development Fellowship Program
A very unique aspect of the Phase I program at the Princess Margaret Cancer Centre is that it is aligned with the Drug Development Program Fellowship training program. The goal of the Drug Development Program Fellowship Program is to train early career investigators in experimental therapeutics and translational research. The Drug Development Program Fellowship Program is directed by Dr. Philippe Bedard and includes 4-6 clinical research fellows annually.
The Drug Development Program Fellowship Program is a world class training program in experimental therapeutics and have consistently attracted trainees worldwide, including Europe, South America, Australia and Asia. Fellows accepted to the Program are expected to complete at least two years of additional training in early Drug Development following their board certification in Medical Oncology in Canada or another jurisdiction. There is a structured curriculum that includes active participation in the planning, coordination and implementation of selected clinical trial protocols mounted by the Drug Development Program. Many graduates of the Drug Development Program Fellowship have become world class leaders in experimental therapeutics upon return home with the knowledge base and skill set acquired. This unique program has trained over 40 young oncologists over the past two decades.