When Kristen Spencer, DO, MPH, was 8 years old, she lost her mother to metastatic colorectal cancer. Access to clinical trials, Dr. Spencer says, was a cornerstone of her mother’s treatment.

“Early-phase research has the potential to find answers where there may not have been any before,” says Dr. Spencer, who joined NYU Langone Health’s Perlmutter Cancer Center in June 2022 as director of the Phase 1 Developmental Therapeutics Program. “Clinical trials offered my mother hope, and I strive to give that to our patients at Perlmutter Cancer Center.”

Phase 1 clinical trials—the earliest stage of clinical research—assess a new treatment, or combination of treatments, for the first time in human subjects. At Perlmutter Cancer Center, early-phase cancer trials involve immune therapies, including novel checkpoint inhibitors, molecularly targeted agents involving DNA damage and repair pathways, and cytotoxic agents, including antibody–drug conjugates with cytotoxic effects that cause cell death or prevent cell growth.

From her time as a medical student at the University of Medicine and Dentistry of New Jersey, Dr. Spencer was drawn to clinical research. This attraction was solidified during her residency and fellowship at Rutgers Robert Wood Johnson Medical School, where she trained with Janice Mehnert, MD, who is now a professor in the Department of Medicine at NYU Grossman School of Medicine and associate director of clinical research at Perlmutter Cancer Center.

“While I was training with Dr. Mehnert in the phase 1 clinic at Rutgers, I fell in love with the idea of taking a concept to the lab and developing it into a rational idea that could be taken back to the bedside to help patients,” says Dr. Spencer, also an assistant professor in the Department of Medicine at NYU Grossman School of Medicine.

Dr. Spencer’s road to directing Perlmutter Cancer Center’s Phase 1 Developmental Therapeutics Program continued at Rutgers Robert Wood Johnson Medical School, where she became an assistant professor and worked with pancreas surgeon Darren R. Carpizo, MD, PhD. With Dr. Carpizo, her research focused on difficult-to-treat gastrointestinal tumors, specifically hepatobiliary and pancreatic cancers, and turning so-called cold tumors—tumors that are not likely to trigger a strong immune response—into hot tumors to make gastrointestinal cancers responsive to immunotherapy in the same way that malignancies such as lung cancer and melanoma have benefited.

Early-Phase Research and the National Cancer Institute’s Experimental Therapeutics Clinical Trials Network

Early-phase studies of chemotherapy combined with immunotherapy became an early focus of Dr. Spencer’s research. During her career at Rutgers Robert Wood Johnson Medical School, she was involved with large multicenter studies conducted through the Hoosier Cancer Research Network and the ECOG-ACRIN Cancer Research Group, where she currently chairs the group’s Genomics Subcommittee and Hepato-Pancreato-Biliary Working Group.

In July 2022, Perlmutter Cancer Center joined the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) Experimental Therapeutics Clinical Trials Network (ETCTN) as part of the Dana-Farber/Harvard Cancer Center Lead Academic Organization. As a member of the ETCTN, Perlmutter Cancer Center early-phase investigators can participate in project teams, which work to develop a portfolio of trials for particular compounds.

As she takes over leadership of the Phase 1 Developmental Therapeutics Program, Dr. Spencer envisions the program to function as a bridge to engage Perlmutter Cancer Center investigators interested in developing their own early-phase studies and assist with navigating barriers that they might face. Among her goals is to leverage her experience developing early-phase studies to mentor Perlmutter Cancer Center faculty who are interested in working with the ETCTN to develop concepts and move ideas into clinical trials. Among the early-phase studies that Dr. Spencer is looking to develop are more immunotherapy-based approaches and novel biomarker-informed studies, in addition to targeted therapies, a field in which she says Perlmutter Cancer Center has already established itself as a national player.

A major effort to achieve this goal involves expanding access to clinical trials. Dr. Spencer cites the need for early-phase solid tumor studies in people who do not respond to treatment. She also plans to implement a parallel effort to continue Perlmutter Cancer Center’s endeavor to expand clinical trial access to New York City’s minority and underserved populations.

“Early-phase clinical trials are an area where minority and underserved populations don’t often get the chance to participate,” Dr. Spencer says. “We have submitted a number of grants that are focusing on social determinants of health and barriers to early-phase trial enrollment for these patients so that we can gather data to develop initiatives that can help change that.”

Recently, Dr. Spencer was awarded a grant from the The Robert A. Winn Diversity in Clinical Trials Award Program to better understand how financial toxicity affects adherence to early-phase studies and influences patient outcomes. Using the COmprehensive Score for financial Toxicity (COST) analysis tool, Dr. Spencer aims to identify ways to reduce costs for patients, which could have an impact on their success on early-phase studies.

Dr. Spencer also plans to strengthen the presence of the Phase 1 Developmental Therapeutics Program at Perlmutter Cancer Center’s network sites in Brooklyn and on Long Island. The program has dedicated investigators at Perlmutter Cancer Center at NYU Langone Hospital—Long Island who participate in all phase 1 meetings and have access to the entire menu of phase 1 trials that are open in Manhattan. The program also has a manual pre-screening program at NYC Health + Hospitals/Bellevue in which a dedicated staff member pre-screens patients and identifies clinical trials for which they might be eligible. Patients are either referred to a trial at Perlmutter Cancer Center—34th Street or treated in phase 1 trials that are available on-site at Bellevue. Both of these initiatives, Dr. Spencer says, could serve as models for establishing a presence for the Phase 1 Developmental Therapeutics Program at Perlmutter Cancer Center—Sunset Park.

The Phase 1 Developmental Therapeutics Program, Dr. Spencer notes, is a premier center for early-phase clinical trials with the most novel compounds. Pharmaceutical companies, she says, are eager to partner on new studies because of the reputation of Perlmutter Cancer Center investigators as experts in conducting early-phase studies.

“I inherited a strong, connected, and motivated team that was built during the time that Dr. Mehnert was the interim director of the program,” Dr. Spencer says. “The role that I see myself playing is, first and foremost, to continue to leverage the enthusiasm that the team has to help them understand how they are part of the overall mission for the Phase 1 Developmental Therapeutics Program and how that offers hope to patients.”