Early-Phase Clinical Trials Unit

UCSF’s Helen Diller Family Comprehensive Cancer Center, funded by the National Cancer Institute (NIH), and the CTSI Clinical Research Services (CRS) program have joined forces to introduce novel agents for patients with incurable diseases through an early-phase clinical trials unit.

This unit has the capability to efficiently screen, assess, and treat patients interested in novel therapies. While currently focused mainly on cancer, support is not limited to cancer investigators or cancer patients and has expanded to non-cancer Phase I trials.

This joint effort has resulted in the opening of more than 40 new treatment studies over the last three years, testing 8 novel molecules.
Pamela N. Munster, MD, Professor of Medicine and Unit Director

The main objectives of this effort are to 1) leverage the expertise of UCSF investigators in multiple disciplines and 2) bring new scientific discoveries and first-in-human novel agents to patients with incurable disease. Studies of interests include novel treatment modalities sponsored by NIH, pharmaceutical sponsors, and the University of California drug discovery effort.

Team members are comprised of oncologists, translational scientists, disease dedicated surgeons and pathologists, translational pharmacologist, investigational pharmacists, and anthropologists, as well as a group of highly specialized high-tech imaging experts. The group meets regularly to oversee the patients’ welfare and discuss scientific progress.

A center-wide integrated business agreement allows for centralized treatment and assessment of all patient needs, integrating administration of standard therapies, intense medical and cardiac monitoring with administration of novel therapies, and pharmacodynamic and pharmacological endpoint assessments.

The formalized collaboration between CTSI's CRS and the Cancer Center has standardized the approach to early-phase treatment interventions at UCSF’s Mt. Zion and Parnassus campuses. The insights gained and the developed procedures have also vastly shortened the time lag for protocol activation, and increased patient enrollment.