Pathos AI has initiated a Phase 1b/2a clinical trial for its CBP/p300 inhibitor, pocenbrodib, in patients with metastatic castration-resistant prostate cancer (mCRPC). The trial will evaluate pocenbrodib as a monotherapy and in combination with existing treatments like abiraterone acetate, olaparib, or 177Lu-PSMA-617. This marks the first clinical-stage asset for Pathos AI.
This trial is significant because it addresses a critical unmet need in mCRPC treatment. Many patients develop resistance to standard anti-androgen therapies, leaving them with limited options. Pocenbrodib’s mechanism of action, inhibiting CBP/p300 proteins that drive cancer cell growth, offers a novel approach to combatting this resistance. Moreover, Pathos AI utilizes a sophisticated biomarker strategy to identify patients most likely to respond, potentially optimizing treatment outcomes.
The P300-02-001 study is a multicenter, open-label trial aiming to enroll approximately 203 mCRPC patients who have progressed after prior therapies. The study’s primary objectives are to evaluate the safety, objective response rate, PSA decline, and pharmacokinetic/pharmacodynamic profile of pocenbrodib, both alone and in combination regimens. This data will inform the recommended Phase 2 dose for future studies.
The commencement of this trial represents a pivotal step for Pathos AI and the development of pocenbrodib. Positive results could validate their precision medicine approach and establish pocenbrodib as a valuable new therapy for mCRPC patients who have exhausted other treatment avenues. Furthermore, it could pave the way for exploring pocenbrodib’s efficacy in other cancer types, solidifying its potential as a versatile therapeutic agent.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
