UCSF Cancer Center
PROJECT
Executing a High-Stakes Phase 1 Trial in Advanced Cancer
ROLE
Clinical Research Coordinator
TIMELINE
Aug 2024 - Jul 2025
TEAM
Early Phase Experimental Therapeutics Team (Data Coordinator, Nurse Practitioner, Oncology Nurse), Medical Oncology Physicians, Sponsors, CROs
Sponsor
Repare Therapeutics
Investigational Agent
Lunresertib
Study Design
Phase 1/1b, multi-center, open-label, dose-escalation
Disease Area
Advanced solid tumors
NCT04855656
01 Summary
I supported a Phase 1 trial evaluating lunresertib alone and in combination in patients with advanced solid tumors, assessing safety, determining the maximum tolerated dose, and evaluating early signs of anti-tumor activity.
Early-phase oncology trials carry long pharmacokinetic days, frequent safety assessments, and complex dosing schedules, and the patients enrolled often have few options left. Getting the execution right mattered as much for them as it did for the data.
CORE COMPETENCIES:
Federal Drug Safety Reporting, Patient Screening, EHR Review, Protocol Execution, Sponsor Communication, Study Visit Coordination, Data Submissions
02 Approach
I led patient screening and enrollment across a high volume of solid tumor cases, spanning ovarian, prostate, colorectal, and brain cancers, and coordinated every standard-of-care procedure tied to the protocol, including scans, biopsies, and infusions. I managed day-to-day sponsor communications and wrote serious adverse event reports for regulatory safety review, translating a complex, biomarker-informed protocol into consistent clinical activity at the site level.
03 Impact
MYTHIC results contributed to Repare's public reports of positive safety and tolerability findings and to the subsequent licensing of lunresertib. Licensing it to Debiopharm means the drug now has the resources to move through later-phase development and toward patients who need it. Beyond that, I was able to help 12 patients and their families navigate what was often their last remaining treatment option.
