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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05665530
Registration number
NCT05665530
Ethics application status
Date submitted
16/12/2022
Date registered
27/12/2022
Date last updated
2/05/2024
Titles & IDs
Public title
A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib in Participants With R/R Hematologic Malignancies
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Scientific title
A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib in Participants With Relapsed/Refractory Hematologic Malignancies
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Secondary ID [1]
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PRT2527-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Aggressive B-Cell Non-Hodgkin's Lymphoma
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Aggressive B-Cell NHL
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Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Mantle Cell Lymphoma (MCL)
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Richter's Syndrome
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T-cell Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - PRT2527
Treatment: Drugs - Zanubrutinib
Experimental: PRT2527 Monotherapy - 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.
Experimental: PRT2527/Zanubrutinib Combination - 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.
Treatment: Drugs: PRT2527
PRT2527 will be administered by intravenous infusion once weekly.
Treatment: Drugs: Zanubrutinib
Zanubrutinib will be provided in capsules for oral administration once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose limiting toxicity (DLT) of PRT2527
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Assessment method [1]
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Dose limiting toxicities will be evaluated over the 21-day observation period for monotherapy and 35-day observation period for combination therapy.
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Timepoint [1]
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Baseline through Day 21 for monotherapy, and baseline through Day 35 for combination therapy.
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Primary outcome [2]
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Safety and tolerability of PRT2527 monotherapy and in combination with zanubrutinib: AEs, CTCAE Assessments
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Assessment method [2]
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Safety and tolerability will be evaluated by incidence of DLTs, dose interruption, modification, and discontinuation due to adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
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Timepoint [2]
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Baseline through approximately 2 years
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Primary outcome [3]
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Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 monotherapy and in combination with zanubrutinib
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Assessment method [3]
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The MTD/RP2D will be established for further investigation in participants with relapsed or refractory hematologic malignancies
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Timepoint [3]
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Baseline through approximately 2 years
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Secondary outcome [1]
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Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Objective response rate (ORR)
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Assessment method [1]
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Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator in accordance with standard disease-specific criteria for the hematologic malignancies under study
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Timepoint [1]
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Baseline through approximately 2 years
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Secondary outcome [2]
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Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib: Duration of response/Complete Response (DOR/DoCR)
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Assessment method [2]
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Duration from time of first observed response (CR or PR) to the earliest date of disease progression, as assessed by the investigator in accordance with standard disease-specific criteria for the hematologic malignancies under study, or death due to any cause, whichever occurs first
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Timepoint [2]
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Baseline through approximately 2 years
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Secondary outcome [3]
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Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib: Maximum observed plasma concentration
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Assessment method [3]
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PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration (Cmax)
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Timepoint [3]
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Baseline through approximately 2 years
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Secondary outcome [4]
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Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib: Area under the curve
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Assessment method [4]
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PRT2527 pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
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Timepoint [4]
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Baseline through approximately 2 years
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Secondary outcome [5]
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Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib: Time of maximum concentration
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Assessment method [5]
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PRT2527 pharmacokinetics will be calculated including the time of maximum concentration (Tmax)
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Timepoint [5]
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Baseline through approximately 2 years
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Eligibility
Key inclusion criteria
- Willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, lifestyle considerations, and other study procedures
- Histologically or cytologically confirmed diagnosis of aggressive B-cell lymphoma
subtypes, MCL, CLL/SLL, including Richter's syndrome, based on local testing , or TCL
(monotherapy only) that have relapsed or become refractory to or be ineligible for
standard-of-care therapy
- Must provide either an archival or fresh tumor tissue sample from a core or
excisional/surgical biopsy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate organ function (hematology, renal, and hepatic)
- Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular
ejection fraction of = 50%
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Have active central nervous system involvement by malignancy, uncontrolled
intercurrent illnesses, and active infections requiring systemic therapy
- Have undergone HSCT within the last 90 days or have graft versus host disease (GvHD)
Grade > 1 at study entry
- Mean corrected QT interval of > 470 msec following triplicate ECG measurements or a
history of long QT Syndrome
- Have severe pulmonary disease with hypoxemia
- History of another malignancy except for adequately treated non-melanoma skin cancer
or lentigo maligna, superficial bladder cancer, and carcinoma in situ of the cervix
without evidence of disease, and asymptomatic prostate cancer without known metastatic
disease and no requirement for therapy
- Concurrent treatment or within 15 days of starting study treatment with strong CYP3A4
inhibitors or inducers or use of moderate CYP3A4 inducers (for combination therapy
only)
- Prior exposure to a CDK9 inhibitor
- Wait at least 5 half-lives of the agent or 14 days after their investigational or
approved therapies before start of study treatment, whichever is shorter
- Mean corrected QT interval of > 470 msec following triplicate ECG measurement or
history of long QT syndrome
- T-Cell leukemias
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/09/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2025
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Actual
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Sample size
Target
104
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment hospital [2]
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Alfred Health - Melbourne
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Recruitment hospital [3]
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Monash Health - Melbourne
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Recruitment hospital [4]
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Linear Clinical Research Ltd - Perth
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3168 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Maryland
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United States of America
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State/province [3]
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Massachusetts
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Virginia
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Country [6]
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Canada
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State/province [6]
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Quebec
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Country [7]
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France
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State/province [7]
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Creteil
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Country [8]
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France
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State/province [8]
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Lille
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Country [9]
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France
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State/province [9]
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Lyon
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Country [10]
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France
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State/province [10]
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Saint-Cloud
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Germany
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State/province [11]
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North Rhine-Westphalia
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Country [12]
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Italy
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State/province [12]
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FC
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Italy
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State/province [13]
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Bologna
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Italy
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State/province [14]
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Ravenna
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Country [15]
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Korea, Republic of
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State/province [15]
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Seoul
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Country [18]
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Poland
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State/province [18]
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Malopolskie
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Country [19]
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Switzerland
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State/province [19]
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Ticino
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United Kingdom
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State/province [20]
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West Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Prelude Therapeutics
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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BeiGene
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective
cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory
(R/R) hematologic malignancies. The purpose of this study is to evaluate the safety,
tolerability, recommended phase 2 dose (PR2D), and preliminary efficacy of PRT2527 as a
monotherapy and in combination with zanubrutinib.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05665530
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Study Contact (Please Do Not Disclose Personal Information)
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Address
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Phone
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See Email
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05665530
Download to PDF