Early Drug Development Service: Phase I Clinical Trials Program

Early Drug Development Service: Phase I Clinical Trials Program


At Memorial Sloan Kettering Cancer Center (MSK), we strive to lead the way in every stage of the research process. Nearly every treatment available today for people with cancer is the result of a clinical trial that started with a phase I study.

The Early Drug Development (EDD) Service conducts phase I trials of promising new drugs in adult patients and pediatric patients with solid tumors in the body or brain. We run broad phase I clinical trials across disease types and molecular targets.

The goals of the Early Drug Development Service are:

  • To provide MSK patients with the earliest opportunities to access the latest drugs against a specific cancer or cancer mutation
  • To advance the research and development of new treatments by determining the optimal safe doses, paving the way for phase II and phase III studies
  • To facilitate the rapid evaluation of promising agents using advanced clinical trial designs, such as basket trials, which target a specific genetic mutation across a range of tumors from different cancer types
  • To educate and train clinical research fellows

Phase I Trials at Memorial Sloan Kettering Cancer Center

Experience. Memorial Sloan Kettering Cancer Center is a National Cancer Institute–designated Comprehensive Cancer Center and has been since 1971, when we were one of the first institutions to receive the designation. At MSK, we are currently conducting more than 600 clinical trials in all phases of research for many types of cancer. Of those, the EDD team is conducting more than 35 phase I studies.

Large Patient Pool. Many phase I trials require a certain number of volunteers. As a high-volume cancer center, MSK can fulfill recruitment objectives for many disease types, including rare cancers. Our expanded comprehensive care facilities at regional sites throughout the area are more convenient for participants and allow for faster study start-up and recruitment. For trials that need larger numbers of volunteers, we lead and participate in multisite trials across the country in collaboration with other cancer centers.

Advanced Technologies. Using our targeted tumor-sequencing test, MSK-IMPACT®, we can match people with any solid tumor, regardless of its origin, with targeted agents based on the molecular profile of the tumor. The test, which the U.S. Food and Drug Administration has authorized, provides investigators with the opportunity to see robust response rates among the participants who are most likely to benefit from experimental therapies. MSK-IMPACT supports the use of basket studies, which can include more participants than disease-specific trials. It can also detect microsatellite instability, so we can identify people who may benefit from immunotherapy.

Collaboration. MSK’s doctors and scientists work together to expand our drug development initiatives. The EDD Service supports theDepartment of Medicine, Human Oncology and Pathogenesis Program, and Sloan Kettering Institute. The EDD team also works closely with the Marie-Josée and Henry R. Kravis Center for Molecular Oncology, Precision Pathology Biobanking Center, Functional Genomics Initiative, Center for Epigenetics Research, and Brain Tumor Center.

Complete Study Support. The experienced primary investigators at MSK oversee the clinical trials at all of our study sites. PIs work with clinical research support teams. These include research program managers, clinical research managers and supervisors, clinical trial nurses, and protocol research study assistants.

Exceptional Patient Care. MSK provides a full range of programs to help people with cancer and their families throughout all phases of treatment. This includes genetic counseling, pain management, rehabilitation, integrative medicine services, and assistance in managing life after treatment. Cancer care teams are in close communication with trial participants.