A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate Carcinoma

Summary

This is a phase 1, open-label study evaluating the safety, clinical pharmacology and clinical activity of AMG 340, 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 AMG 340 monotherapy in subjects with mCRPC.

Timeline

Start

2021-04-29

Primary completion

2024-06-24

Completion

2024-06-24

Outcome

Outcome not reported

Stopped (Business): “Sponsor strategic decision”

Drugs

Indications