- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05682170
Study of the ZN-d5 and ZN-c3 in Subjects With Acute Myeloid Leukemia (AML)
February 29, 2024 updated by: K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
A Phase 1/2 Dose Escalation Study of the BCL-2 Inhibitor ZN-d5 and the WEE1 Inhibitor ZN-c3 in Subjects With Acute Myeloid Leukemia
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is an open-label multicenter Phase 1/2 dose escalation study, evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of the novel BCL-2 inhibitor ZN-d5 and Wee1 inhibitor ZN-c3 in subjects with AML.
Study Type
Interventional
Enrollment (Estimated)
95
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
- Email: medicalaffairs@zentalis.com
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Pankit Vachhani, MD
- Phone Number: 205-975-7850
- Email: pvachhani@uabmc.edu
-
-
California
-
San Francisco, California, United States, 94110
- Recruiting
- University of California San Francisco
-
Contact:
- Catherine Smith, MD
- Phone Number: 415-353-2421
- Email: Catherine.Smith@ucsf.edu
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-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Dana Farber Cancer Institute
-
Contact:
- Eric Winer, MD
- Phone Number: 877-442-3324
- Email: EricS_Winer@DFCI.HARVARD.EDU
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-
New York
-
Bronx, New York, United States, 10467
- Recruiting
- Albert Einstein College of Medicine - Montefiore Medical Center
-
Contact:
- Ioannis Mantzaris, MD
- Phone Number: 718-920-4826
- Email: IMANTZAR@montefiore.org
-
New York, New York, United States, 10016
- Recruiting
- NYU Langone Health
-
Contact:
- Mohammad Abdul Hay, MD
- Phone Number: 646-501-4818
- Email: maher.abdulhay@nyulangone.org
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New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Raajit Rampal, MD
- Phone Number: 212-639-2194
- Email: rampalr@mskcc.org
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-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- University of North Carolina at Chapel Hill
-
Contact:
- Joshua Zeidner, MD
- Phone Number: 919-966-4432
- Email: joshua_zeidner@med.unc.edu
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- James Cancer Hospital and Solove Research Institute
-
Contact:
- Grieselhuber Grieselhuber, MD
- Phone Number: 614-366-1164
- Email: Nicole.Grieselhuber@osumc.edu
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health and Science University
-
Contact:
- Ronan Swords, MD
- Phone Number: 503-494-9014
- Email: swords@ohsu.com
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Tennessee
-
Nashville, Tennessee, United States, 37203
- Recruiting
- TriStar Bone Marrow Transplant
-
Contact:
- Stephen Strickland, MD
- Phone Number: 615-329-7274
- Email: XOResearchCentralScreening@USONCOLOGY.COM
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-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- University of Texas MD Anderson Cancer Center
-
Contact:
- Guillermo Garcia-Manero, MD
- Phone Number: 713-745-3428
- Email: ggarciam@mdanderson.org
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-
Wisconsin
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Madison, Wisconsin, United States, 53792
- Recruiting
- University of Minnesota
-
Contact:
- Mark Juckett, MD
- Phone Number: 612-676-4200
- Email: juck0001@umn.edu
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- The Medical College of Wisconsin
-
Contact:
- Guru Subramanian Guru Murthy, MD
- Phone Number: 414-805-8900
- Email: cccto@mcw.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults with AML (including secondary or therapy-related), relapsed from or refractory to one or more prior lines of therapy, which may include venetoclax except in Expansion Cohort A
- ECOG performance status score ≤2.
- Projected life expectancy of at least 12 weeks.
- Estimated glomerular filtration rate ≥60 mL/min
- Women of childbearing potential must not be pregnant and must use effective birth control during the study and for 6 months after the last dose of study drugs.
- Men must agree to use a condom when having intercourse during the study and for 3 months after the last dose of study drugs.
Exclusion Criteria:
- Known active CNS involvement
- Diagnosis of acute promyelocytic leukemia.
- Peripheral blast count of >25 × 109/L (cytoreduction permitted).
- Adequate washout from prior therapy including hematopoietic stem cell transplant and recovery from prior treatment-related toxicities to Grade 2 or lower
- Significant cardiovascular disease
- Corrected QT interval (QTc) of >480 msec
- Active hepatitis B or hepatitis C infection
- Concurrent treatment with strong CYP3A inhibitors or strong or moderate CYP3A inducers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute Myeloid Leukemia
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination Phase 2: Dose Expansion |
Oral agent
Other Names:
Oral agent
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Observed dose limiting toxicities
Time Frame: At the end of Cycle 1 (each cycle is 28 days)
|
Observed Dose Limiting Toxicities (DLTs) in DLT evaluable subjects.
|
At the end of Cycle 1 (each cycle is 28 days)
|
Incidence, severity, and relatedness of adverse events( AEs)
Time Frame: Through study completion, typically < 12 months
|
Through study completion, typically < 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1. To investigate the plasma PK of ZN-c3 when given as monotherapy - Maximum Plasma Concentration
Time Frame: Through study completion, typically <12 months
|
The maximum plasma concentration (Cmax) of ZN-c3 (and its potential metabolites, as applicable) will be determined
|
Through study completion, typically <12 months
|
2. To investigate the plasma PK of ZN-c3 when given as monotherapy - Area under the plasma concentration-time curve from 0 to 24h
Time Frame: Through study completion, typically < 12 months
|
Area under the plasma concentration-time curve from 0 to 24h [AUC0-24h] of ZN-c3 (and its potential metabolites, as applicable) will be determined
|
Through study completion, typically < 12 months
|
5. To investigate the plasma PK of ZN-c3 and ZN-d5 when given in combination - Maximum Plasma Concentration
Time Frame: Through study completion, typically < 12 months
|
The maximum plasma concentration (Cmax) of ZN-c3 (and its potential metabolites, as applicable) and ZN-d5 (and its potential metabolites, as applicable) will be determined
|
Through study completion, typically < 12 months
|
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
Time Frame: Through study completion, typically < 12 months
|
Area under the plasma concentration-time curve from 0 to 24h [AUC0-24h] of ZN-c3 (and its potential metabolites, as applicable) and ZN-d5 (and its potential metabolites, as applicable) will be determined
|
Through study completion, typically < 12 months
|
Rate and duration or remission according to the European LeukemiaNet 2017 criteria
Time Frame: Through study completion, typically < 12 months
|
Through study completion, typically < 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc., K-Group Alpha
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
February 1, 2026
Study Registration Dates
First Submitted
December 19, 2022
First Submitted That Met QC Criteria
January 3, 2023
First Posted (Actual)
January 12, 2023
Study Record Updates
Last Update Posted (Actual)
March 1, 2024
Last Update Submitted That Met QC Criteria
February 29, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ZN-d5-004C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on ZN-d5 ZN-c3
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OHSU Knight Cancer InstituteOregon Health and Science UniversityWithdrawnAnatomic Stage IV Breast Cancer AJCC v8 | Metastatic Triple-Negative Breast Carcinoma | Stage III Fallopian Tube Cancer AJCC v8 | Stage III Ovarian Cancer AJCC v8 | Stage III Primary Peritoneal Cancer AJCC v8 | Stage IV Fallopian Tube Cancer AJCC v8 | Stage IV Ovarian Cancer AJCC v8 | Stage IV Primary... and other conditionsUnited States
-
Zentera Therapeutics HK LimitedTerminated
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K-Group Alpha, Inc., a wholly owned subsidiary...Not yet recruiting
-
K-Group, Beta, Inc., a wholly owned subsidiary...RecruitingHigh-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal CancerUnited States, Australia, France
-
Zentera Therapeutics HK LimitedRecruiting
-
K-Group, Beta, Inc., a wholly owned subsidiary...Recruiting
-
K-Group Alpha, Inc., a wholly owned subsidiary...RecruitingAcute Myeloid Leukemia | Non Hodgkin LymphomaCroatia, Australia, Bulgaria, Korea, Republic of, Ukraine, Poland, Spain
-
K-Group Alpha, Inc., a wholly owned subsidiary...Active, not recruitingAL Amyloidosis | AmyloidosisSpain, Australia, Israel, United States, Greece, Italy, Cyprus
-
Joyce Liu, MDNational Cancer Institute (NCI); ZentalisNot yet recruitingUterine Cancer | Uterine Serous Carcinoma | Uterine CarcinomaUnited States
-
K-Group, Beta, Inc., a wholly owned subsidiary...RecruitingUterine Serous CarcinomaUnited States, Australia, Canada, Georgia