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Phase I trials establish foundational safety data for new agents or combinations. The principal aims are to characterize pharmacokinetics/pharmacodynamics, identify dose-limiting toxicities (DLTs), and determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) and schedule. While signals of antitumor activity may be observed, efficacy is not the primary endpoint. Phase II then explores activity in defined populations, and phase III tests comparative effectiveness against standard therapies. The APRN’s role includes meticulous adverse event assessment and grading (e.g., CTCAE), timely reporting, protocol-directed management of toxicities, patient education on risks/benefits, and rigorous consent processes that communicate uncertainties inherent to early-phase research. Understanding eligibility criteria, washout periods, and concomitant medication restrictions prevents protocol deviations. Close collaboration with research coordinators, pharmacists, and investigators ensures data integrity and participant safety, supporting ethical conduct and scientific validity of trial outcomes.