1. First-in-Human, open-label Phase I
2. Weekly 1-hour IV infusion, 28-day cycles
3. Standard 3+3 dose escalation (up to 36 patients)
4. 6-patient expansion cohort at MTD/RP2D

Objectives

1. Primary: MTD / RP2D
2. Secondary:
   1. Safety profile (CTCAE v5.0)
   2. PK characterization

• Pharmacodynamic target engagement

1. Preliminary antitumor activity (RECIST 1.1 / RECIL 2017)

Translational Strength

1. Mandatory paired biopsies in expansion cohort
2. PBMC and tumor metabolomics (301 metabolites)
3. IHC confirmation of bioenergetic stress markers

This design maximizes learning per patient, increasing downstream Phase II confidence.