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Cyclin-dependent kinase 9 inhibitor
PRT2527 + Zanubrutinib for Blood Cancers
Phase 1
Recruiting
Research Sponsored by Prelude Therapeutics
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 baseline through approximately 2 years
Awards & highlights
Study Summary
This trial studies a new drug for cancer treatment to see if it's safe, effective and what the best dose is.
Who is the study for?
This trial is for adults with certain aggressive blood cancers like B-cell lymphoma, mantle cell lymphoma, or chronic leukemia that have stopped responding to standard treatments. Participants must be in good physical condition (ECOG 0 or 1), able to follow the study plan, and have proper organ function. They can't join if they've had recent cancer treatment that conflicts with the study drugs, severe heart issues, lung disease with low oxygen levels, or a history of other cancers except some skin and localized cancers.Check my eligibility
What is being tested?
The trial is testing PRT2527 alone and combined with Zanubrutinib in patients who have relapsed or refractory hematologic malignancies. It's a Phase 1 study focusing on finding the safest dose that works (PR2D) while checking how well these treatments work against these types of blood cancers.See study design
What are the potential side effects?
Possible side effects include those common to cancer therapies such as fatigue, nausea, diarrhea; specific risks related to PRT2527 might involve changes in liver enzymes indicating liver stress. Zanubrutinib may cause bleeding problems, infections due to low white blood cell counts, high blood pressure and second primary malignancies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through approximately 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity (DLT) of PRT2527
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 monotherapy and in combination with zanubrutinib
Safety and tolerability of PRT2527 monotherapy and in combination with zanubrutinib: AEs, CTCAE Assessments
Secondary outcome measures
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Duration of response/Complete Response (DOR/DoCR)
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Objective response rate (ORR)
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib: Area under the curve
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: PRT2527/Zanubrutinib CombinationExperimental Treatment2 Interventions
PRT2527 will be administered by intravenous infusion once weekly on a 35-day treatment cycle for Cycle 1 followed by 21-day treatment for subsequent treatment cycles at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication specific cohort during the dose confirmation phase.
Zanubrutinib will be administered orally as combination therapy once daily.
Group II: PRT2527 MonotherapyExperimental Treatment1 Intervention
PRT2527 will be administered by intravenous infusion once weekly on a 21-day treatment cycle at the dose level assigned during the dose escalation phase and at the defined RP2D dose for indication-specific cohorts during the dose confirmation phase.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRT2527
2022
Completed Phase 1
~30
Zanubrutinib
2017
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Prelude TherapeuticsLead Sponsor
8 Previous Clinical Trials
551 Total Patients Enrolled
BeiGeneIndustry Sponsor
175 Previous Clinical Trials
28,710 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I have been treated with a CDK9 inhibitor before.I have a severe lung condition that causes low oxygen levels.My condition is T-Cell leukemia.I do not have cancer in my brain, serious illnesses, or infections needing strong medication.I can provide a recent or past tissue sample from my tumor.My blood, kidney, and liver functions are all within normal ranges.I am not taking strong or moderate drugs that affect liver enzymes within 15 days of starting the study.I have waited the required time after my last cancer therapy before starting a new treatment.My heart's electrical activity takes longer than normal to recharge.I had a stem cell transplant within the last 3 months or have moderate to severe GvHD.I have had cancer before, but it was either skin cancer, superficial bladder cancer, cervical carcinoma in situ without current disease, or asymptomatic prostate cancer without spread and no need for treatment.My aggressive B-cell lymphoma or TCL has not responded to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: PRT2527 Monotherapy
- Group 2: PRT2527/Zanubrutinib Combination
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.
Has PRT2527 been ratified by the Food & Drug Administration?
"Taking into account the fact that PRT2527 is in Phase 1 of its trial, our team at Power ascertained a score of 1 for safety due to limited evidence supporting both efficacy and security."
Answered by AI
To what extent is the participant pool expanding for this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this study opened up on March 1st 2023 and was last edited on February 21st 2023. As of now the trial is looking for 51 participants at a single medical centre."
Answered by AI
Is this medical research actively recruiting participants?
"Affirmative. Clinicaltrials.gov reveals that this study is presently enrolling participants and was initially posted on March 1st 2023, with the most recent update taking place February 21st of the same year. Specifically, 51 patients are needed from a single medical centre."
Answered by AI
What is the ultimate objective of this research endeavor?
"As per the trial funder, Prelude Therapeutics, primary outcome will be assessed over a Baseline period of two years and is classified as Dose Limiting Toxicity (DLT) in relation to PRT2527. Moreover, this investigation will measure secondary objectives such as Pharmacokinetic profile of PRT2527: Area under Curve (AUC), Time of Maximum Concentration (Tmax), and Anti-tumor Activity: Duration of Response/Complete Response (DOR/DoCR)."
Answered by AI
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