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Wee1 Inhibitor
ZN-d5 + ZN-c3 for Acute Myeloid Leukemia
Phase 1 & 2
Recruiting
Research Sponsored by K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, typically <12 months
Awards & highlights
Study Summary
This trial is testing new drugs to treat AML, a type of blood cancer.
Who is the study for?
Adults with Acute Myeloid Leukemia (AML) who have not responded well to previous treatments can join this trial. They should be relatively stable (ECOG ≤2), expected to live at least 12 weeks, and have good kidney function. Women must use birth control, and men must use condoms during the study and for some time after.Check my eligibility
What is being tested?
The trial is testing two drugs: ZN-d5, a BCL-2 inhibitor, and ZN-c3, a Wee1 inhibitor. It's in phases 1/2 which means they're looking at what doses are safe (phase 1) and how effective these drugs are (phase 2) in treating AML.See study design
What are the potential side effects?
Possible side effects of ZN-d5 and ZN-c3 may include changes in blood counts leading to increased risk of infections or bleeding, fatigue, nausea or vomiting. There might also be liver-related issues or reactions related to drug infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, typically <12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, typically <12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence, severity, and relatedness of adverse events( AEs)
Observed dose limiting toxicities
Secondary outcome measures
1. To investigate the plasma PK of ZN-c3 when given as monotherapy - Maximum Plasma Concentration
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
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Acute Myeloid LeukemiaExperimental Treatment2 Interventions
Phase 1: Dose Escalation- c3 monotherapy and d5+c3 combination
Phase 2: Dose Expansion
Find a Location
Who is running the clinical trial?
K-Group Alpha, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.Lead Sponsor
3 Previous Clinical Trials
266 Total Patients Enrolled
K-Group Alpha, Inc. a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc.Study DirectorK-Group Alpha
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an active hepatitis B or C infection.My kidneys are functioning well.I can take care of myself but might not be able to do heavy physical work.I have been diagnosed with acute promyelocytic leukemia.I have a serious heart condition.I have recovered from previous cancer treatments with mild side effects.I am not taking strong medication that affects liver enzyme activity.I agree to use a condom during the study and for 3 months after.I have AML and my previous treatments, except venetoclax, didn't work.My cancer has spread to my brain or spinal cord.I am not pregnant and will use birth control during and 6 months after the study.
Research Study Groups:
This trial has the following groups:- Group 1: Acute Myeloid Leukemia
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total enrollment of this medical experiment?
"Affirmative. The clinicaltrials.gov portal verifies that the trial, whose initial posting was on December 1st 2022, is presently recruiting participants. 95 volunteers need to be enrolled from 3 distinct medical departments."
Answered by AI
Are there any openings left for individuals to join this research endeavor?
"Affirmative. According to the information accessible on clinicaltrials.gov, this medical experiment is actively enrolling participants from its initial posting date of December 1st 2022 and most recent update of January 3rd 2023. The trial necessitates 95 patients over three different sites."
Answered by AI
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