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Acute Myeloid Leukemia for Acute Myeloid Leukemia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Acute Myeloid LeukemiaZN-d5 ZN-c3 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

A Phase 1/2 dose escalation study of BCL-2 Inhibitor ZN-d5 and the Wee1 Inhibitor ZN-c3 in Subjects with Acute Myeloid Leukemia (AML).

Eligible Conditions
  • Acute Myeloid Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
ZN-c3
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1
Minnelide

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Through study completion, typically <12 months

Day 28
Observed dose limiting toxicities
Month 12
2. To investigate the plasma PK of ZN-c3 when given as monotherapy - Area under the plasma concentration-time curve from 0 to 24h
5. To investigate the plasma PK of ZN-c3 and ZN-d5 when given in combination - Maximum Plasma Concentration
6. To investigate the plasma PK of ZN-c3 and ZN-d5 when given in combination - Area under the plasma concentration-time curve from 0 to 24h
Incidence, severity, and relatedness of adverse events( AEs)
Rate and duration or remission according to the European LeukemiaNet 2017 criteria
Month 12
1. To investigate the plasma PK of ZN-c3 when given as monotherapy - Maximum Plasma Concentration

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
ZN-c3
1
ZN-c3
1
Minnelide

Trial Design

1 Treatment Group

Acute Myeloid Leukemia
1 of 1

Experimental Treatment

95 Total Participants · 1 Treatment Group

Primary Treatment: Acute Myeloid Leukemia · No Placebo Group · Phase 1 & 2

Acute Myeloid LeukemiaExperimental Group · 2 Interventions: ZN-d5 ZN-c3, ZN-c3 · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, typically <12 months

Who is running the clinical trial?

K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
236 Total Patients Enrolled
K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.Study DirectorK-Group Alpha

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are an adult with Acute Myeloid Leukemia (AML) that has either relapsed or is resistant to one or more previous treatments, possibly including venetoclax (not applicable for Expansion Cohort A).
You have an ECOG performance status score of 2 or less.
Male participants must commit to condom utilization while taking part in the study and for a three month period following completion of dosing.
You have a projected life expectancy of at least three months.
Your estimated glomerular filtration rate is at least 60 mL/min.
Female participants of reproductive age must not be pregnant and must use dependable contraception during the study duration as well as for 6 months after the final dose of investigational treatment.
References

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