A Phase I Open-label Multi-center Clinical Study to Evaluate Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Anti-Tumor Activity of AC176 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) Who Have Progressed on at Least Two Prior Systemic Therapies
Brief description of study
This study is designed for patients diagnosed with metastatic castration resistant prostate cancer (mCRPC).
This is a Phase I, first-in-human, open-label, multi-center dose-escalation study of AC176, a novel androgen receptor (AR) degrader, given as a single agent. Up to 36 patients are expected to be enrolled in this study.
In this study, AC176 will be given orally (PO) once daily on a 28-day schedule. The starting dose will be 30 mg and will follow a 3+3 design (see Study Schema below). If suggested by emerging safety or PK findings, or as appropriate based on other data from previous cohorts, an alternative dosing level and/or dosing schedule may be considered. The study will identify a maximum tolerated dose (MTD) if possible, with safety and tolerability data. The totality of data collected on AC176 treatment may be used to suggest a recommended Phase II dose.
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