A Study of TNB-585 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma
Status:
Recruiting
Trial end date:
2023-03-01
Target enrollment:
Participant gender:
Summary
This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical
activity of TNB-585, a PSMA x CD3 T-cell engaging bispecific antibody, in subjects with
metastatic castrate-resistant prostate cancer (mCRPC) who have received 2 or more prior lines
of therapy. The study consists of 2 parts, a monotherapy dose escalation (Arm A) and a
monotherapy dose expansion (Arm B). Once the maximum tolerated dose (MTD) or recommended
phase 2 dose (RP2D) is identified in Arm A, Arm B will be initiated to further characterize
the safety, tolerability and pharmacokinetic (PK) profile of the MTD/RP2D dose of TNB-585
monotherapy in subjects with mCRPC.