A Study of FT-7051 in Men With MCRPC

Inclusion Criteria:

Signed informed consent
Diagnosis of progressive metastatic castration-resistant prostate cancer (mCRPC)
Previously failed at least one potent anti-androgen therapy
Castrate levels of serum testosterone
ECOG performance status 0-2
Adequate bone marrow function
Adequate kidney, heart and liver function

Exclusion Criteria:

Prior solid organ transplant
Prior treatment with small molecules including chemotherapy, antibody, or other experimental anticancer therapeutic within 4 weeks of first dose of study treatment
Prior radiation therapy within 4 weeks prior to initiation of study treatment (including radiofrequency ablation)
Prior androgen antagonist therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide) within 2 weeks
Prior radium-223 therapy within 6 weeks
Symptomatic, untreated or actively progressing central nervous system (CNS) metastasis
Unstable or severe, uncontrolled medical condition (e.g., unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes, active or uncontrolled infection requiring systemic therapy) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgement, increase the risk to the patient associated with participation in the study
Concomitant medications that cause Torsades de Pointes that have not reached steady state before first dose of the study drug
Concomitant medications that are strong inhibitors or inducers of CYP3A4 or an inhibitor of P-gp
History of infection with human immunodeficiency virus (HIV)
Active infection with hepatitis B, or hepatitis C virus