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ZN-d5

Phase 1

Acute Myeloid Leukemia | Small molecule | Oncology |Zentalis Pharmaceuticals, Inc.|Last Updated: Sep 19, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

ZN-d5 · 3 trials · 5 indications

Phase 1 3
NCT05199337Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) AmyloidosisAmyloidosis
COMPLETED18 Analytics
NCT04854174A Food Effect Study of ZN-d5 in Healthy Female VolunteersHealthy Volunteers
COMPLETED16 Analytics
NCT04500587Phase 1 First in Human Study of ZN-d5 as a Single AgentAcute Myeloid Leukemia
COMPLETED39 Analytics
PHASE1COMPLETED
Phase 1/2 Study of ZN-d5 for the Treatment of Relapsed or Refractory Light Chain (AL) Amyloidosis
AmyloidosisUnlock trial analytics
PHASE1COMPLETED
A Food Effect Study of ZN-d5 in Healthy Female Volunteers
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Phase 1 First in Human Study of ZN-d5 as a Single Agent
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
18 Months

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

Dose limiting toxicities
18 Months

Incidence of Dose-limiting toxicities (DLTs) observed in DLT evaluable subjects

ZN-d5 Bioavailability
2 months

Maximum concentration (Cmax)

Observed Dose Limiting Toxicities
Through completion of Cycle 1; 1 to 2 months.

Observed Dose Limiting Toxicities (DLTs) in DLT-evaluable subjects.

Incidence and severity of AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v 5.0
Through study completion, typically < 12 months

Safety profile of ZN-d5.

Secondary Endpoints

PK Parameter: Finding max concentration (Cmax) of ZN-d5
48 months
PK Parameter: Finding time to maximum concentration (Tmax) of ZN-d5
48 months
PK Parameter: Finding half-life of ZN-d5
48 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment ArmEXPERIMENTALSubjects 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.
Healthy VolunteerEXPERIMENTALHealthy Volunteer
ZN-d5 Single Agent Dose Escalation - NHLEXPERIMENTALNon-Hodgkin Lymphoma
ZN-d5 Single Agent Dose Escalation - AMLEXPERIMENTALAcute Myeloid Leukemia

Interventions

NameTypeDescription
ZN-d5DRUGZN-d5 will be administered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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...

Countries:United StatesAustraliaCyprusGreeceIsraelItalySpainNew ZealandBulgariaCroatiaPolandSouth KoreaUkraine
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Frequently asked questions about ZN-d5

What is ZN-d5 used for?

ZN-d5 is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia, Non Hodgkin Lymphoma, and AL Amyloidosis. It has also been evaluated in healthy volunteers in food effect studies. The drug is in clinical development by Zentalis Pharmaceuticals.

What does ZN-d5 target?

ZN-d5 is a small molecule therapeutic developed by Zentalis Pharmaceuticals. The specific molecular target of ZN-d5 has not been disclosed in available clinical trial information. The drug is being investigated for its potential activity in hematologic malignancies and amyloidosis.

Who makes ZN-d5?

ZN-d5 is being developed by Zentalis Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol ZNTL. The company is conducting clinical trials to evaluate the safety and efficacy of ZN-d5 in patients with certain cancers and amyloidosis.

What phase is ZN-d5 in?

ZN-d5 is in Phase 1 clinical development. All three clinical trials listed for ZN-d5 are Phase 1 studies and have been completed. The drug remains investigational and has not been approved by regulatory authorities for any indication.

What clinical trials is ZN-d5 in?

ZN-d5 has been studied in three completed Phase 1 clinical trials: NCT04500587, a first-in-human study in Acute Myeloid Leukemia and Non Hodgkin Lymphoma; NCT04854174, a food effect study in healthy female volunteers; and NCT05199337, a Phase 1/2 study in relapsed or refractory AL Amyloidosis.

Is ZN-d5 the same as other drugs?

ZN-d5 is the investigational name used by Zentalis Pharmaceuticals for this drug candidate. No alternative names have been disclosed in the clinical trial records. The drug is identified solely as ZN-d5 in the studies registered on ClinicalTrials.gov.