ZN-d5

P1/2, N=135, Active, not recruiting, K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. | Recruiting --> Active, not recruiting

P1, N=8, Terminated, Zentera Therapeutics HK Limited | N=30 --> 8 | Trial completion date: Mar 2024 --> May 2023 | Enrolling by invitation --> Terminated; Sponsor's decision

Recently, the addition of subcutaneous daratumumab to the standard first-line regimen of cyclophosphamide, bortezomib, and dexamethasone (CyBorD) was shown to significantly improve complete hematologic and organ response rates. This study will evaluate treatment of AL amyloidosis utilizing BCL-2 inhibition. Dose escalation cohorts arecurrently undergoing evaluation and the study is open to enrollment. Upon determination of the RP2D, the study will commence Phase 2.

P1, N=115, Recruiting, K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc. | N=85 --> 115 | Trial completion date: May 2023 --> Jan 2025 | Trial primary completion date: Oct 2022 --> Aug 2024

P1/2, N=95, Recruiting, K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.

These results justify testing the ZN-d5 and ZN-c3 combination or possibly the triple combination including azacitidine in AML patients independently of TP53 status. Due to synergism observed with these combination(s) and activity in samples from patients resistant to venetoclax, activity may be seen in patients with low sensitivity to Bcl-2 inhibitors or even in patients who progressed on venetoclax plus azacitidine.