MD-01 included patients with which disease stages?

• A. Stage I-III, all subtypes
• B. Stage IV only
• C. Stage 0 only
• D. All stages

Answer: (B)

In clinical trials, the stage of disease is a key factor for determining who can join and how outcomes are interpreted. MD-01 is described as including patients with Stage IV disease only, which means it enrolled individuals with metastatic cancer. This choice creates a homogeneous group where systemic therapy effects can be meaningfully evaluated, since all participants have advanced disease and typically measurable tumors.

Why this matters: Stage IV patients often need systemic treatment rather than local, curative approaches, so the trial can assess the drug’s activity, safety, and endpoints like objective response or progression-free survival in a consistent setting. Including earlier stages would mix populations with very different treatment goals and endpoints (for example, potential cure with surgery or radiation), making it harder to detect a true drug effect and potentially obscuring safety signals.

Stage 0 (carcinoma in situ) and stages I–III represent localized disease with different management and prognosis, so they’re not aligned with a trial designed to test a systemic therapy in metastatic disease. Enrolling all stages would dilute the findings and compromise the study’s ability to evaluate efficacy in the intended population.

Thus, Stage IV only is the best-fit inclusion for this study.