Stopped: Strategic decision made following an assessment of preliminary PK data from the Part 1 portion of the trial showing a lack of dose proportional exposure and the increasing complexity and associated development costs in this landscape.
BBI-825 is a potent, selective, oral, small molecule inhibitor of ribonucleotide reductase (RNR). This is a first-in-human, open-label, non-randomized, 3-part, Phase 1/2 study to determine the safety profile and identify the maximum tolerated dose and recommended Phase 2 dose of BBI-825 administered as a single agent and in combination with select targeted therapies.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Frequency and severity of treatment emergent adverse events (TEAEs) of BBI-825
Timeframe: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of BBI-825
Timeframe: Start of Cycle 1 until 30 days following last dose (each cycle is 28 days)