Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Study Drug
ZN-d5 · 2 trials · 4 indications
Incidence and severity of adverse events (AEs), graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects
Observed Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects.
Safety profile of ZN-d5.
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Subjects will receive ZN-d5 orally (PO), once (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
| ZN-d5 Single Agent Dose Escalation - NHL | EXPERIMENTAL | Non-Hodgkin Lymphoma |
| ZN-d5 Single Agent Dose Escalation - AML | EXPERIMENTAL | Acute Myeloid Leukemia |
| Name | Type | Description |
|---|---|---|
| ZN-d5 | DRUG | ZN-d5 will be administered orally |
Key Inclusion Criteria: 1. Diagnosis of AL amyloidosis based on histopathology, the presence of characteristic appearance on electron microscopy, or mass spectrometry typing of amyloid. 2. Prior AL amyloidosis treatment and has received at least one, but no more than three lines of prior therapy; 3...
ZN-d5 is an investigational small molecule developed by Zentalis Pharmaceuticals, Inc. (ticker ZNTL) for oncology indications. It has been studied in acute myeloid leukemia, non-Hodgkin lymphoma, and light chain (AL) amyloidosis. ZN-d5 remains in clinical development and is not approved for any indication.
ZN-d5 was studied as a single agent in a Phase 1 first-in-human trial in adults with acute myeloid leukemia and non-Hodgkin lymphoma. That study, NCT04500587, enrolled 39 patients and is completed. ZN-d5 is investigational and has not been approved for the treatment of acute myeloid leukemia or any other condition.
Zentalis Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ZNTL, is the developer of ZN-d5. The company sponsored the clinical studies of the compound, including the Phase 1 first-in-human trial and the Phase 1/2 study in relapsed or refractory light chain (AL) amyloidosis.
ZN-d5 has been evaluated in Phase 1 clinical development. Two Phase 1 studies have been conducted: a first-in-human monotherapy trial and a Phase 1/2 study in relapsed or refractory light chain (AL) amyloidosis. Both trials are completed, and ZN-d5 is not approved by the FDA.
ZN-d5 has been studied in two completed trials. NCT04500587 was a Phase 1 first-in-human study of ZN-d5 as a single agent in acute myeloid leukemia and non-Hodgkin lymphoma, enrolling 39 patients. NCT05199337 was a Phase 1/2 study of ZN-d5 in relapsed or refractory light chain (AL) amyloidosis, enrolling 18 patients across the United States, Australia, Cyprus, Greece, Israel, Italy, and Spain.
ZN-d5 was evaluated in a Phase 1/2 study for the treatment of relapsed or refractory light chain (AL) amyloidosis. That trial, NCT05199337, enrolled 18 adults and is completed. ZN-d5 is investigational in this setting and has not received regulatory approval for AL amyloidosis.