Early Phase Clinical Research Support

Olivier Rixe, MD, PhD

Early Phase Clinical Research Support (EPCRS) at the University of New Mexico Comprehensive Cancer Center (UNMCCC) prioritizes, promotes, and supports the development of early phase human clinical trials based on scientific merit and/or clinical relevance to the unique populations of cancer patients in our catchment area.

EPCRS develops hypothesis- or technology-driven studies that translate diagnostic or therapeutic concepts developed in the four UNMCCC Research Programs into clinical investigations. The EPCRS focuses on:

  • first-in-human clinical trials testing novel therapeutic cancer agents discovered at UNMCCC,
  • phase I/II trials testing agents identified from our drug repurposing strategy,
  • evaluation of new biomarkers, and
  • evaluation of challenges related to participation of racial/ethnic and socioeconomically underserved populations in collaboration with the Cancer Control Program.

This objective is supported by the vigor of our four Research Programs, the active partnerships with our consortium members, the robustness of the infrastructure developed over the past 5 years (clinical trials office, shared core facilities, New Mexico Cancer Care Alliance), and the increasing and unmet needs for the population of New Mexico to access innovative early phase trials.

EPCRS funds laboratory-based studies. The maximum award for these pilot grants is $50,000 for one year. Applications are accepted on a rolling basis and are reviewed monthly by a UNMCCC scientific committee.

The Experimental Therapeutics Unit at UNMCCC (Director: Olivier Rixe, MD, PhD) is a unique resource for the State of New Mexico and our multi-ethnic population. It is the only program in the State that can make available to cancer patients new therapeutics that are in the early phase of their development.

The program:

  • develops and conducts first-in-human clinical trials,
  • tests novel therapeutic cancer agents (including nanoparticles, virus-like particles, small molecules, or monoclonal antibodies)
  • translates novel scientific discoveries into clinical trials,
  • evaluates agents from the consortium of drug repurposing, and
  • investigates new biomarkers including genomic, epigenetic, and imaging systems.

The Phase 1 unit staff currently includes 1 oncology research nurse, 3 research coordinators, a nurse practitioner, a patient navigator, three specimen coordinators, one regulatory coordinator and one data entry staff.

The clinical trials offered through the Phase 1 unit do not compete with clinical trials in the community but rather fit in a unique niche offering treatments to patients who have exhausted other avenues of therapy or have a rare type of disease for which treatments are difficult to find. This unit attracts referrals from a wide catchment area that includes more than 100 oncologists in New Mexico, Western Texas, and Eastern Arizona.

In 2017, the first full year in which the UNMCCC Phase 1 unit was in operational, 35 patients were enrolled in phase 1 clinical trials, mostly first-in-human studies.

To address the specific needs of our population related to early drug development in oncology (racial and socioeconomic disparities), a working group was launched in 2017 to develop projects related to these specific needs (Rixe, Ginossar, Sussman, Mishra). UNMCCC funded 2 new projects submitted in the last funding period.