Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)Phase 1NCT05665530
A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies
A Phase 1 study testing PRT2527, Zanubrutinib and Venetoclax in people with Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Prelude Therapeutics Incorporated at 24 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL)
- What is being tested?
- PRT2527, Zanubrutinib and Venetoclax
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 24 sitesin 10 countries
- Study dates
- 12 Sep 2023to 21 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, MZL, or CLL/SLL (including Richter's syndrome) based on local testing, or TCL (monotherapy only), AML, CMML, MDS, or MDS/MPN overlap syndrome that have relapsed or become refractory to or be ineligible for standard-of-care therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2.
- Adequate organ function (hematology, renal, and hepatic)
- Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%
Who cannot join
- 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
- 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
- Prior exposure to a CDK9 inhibitor
Show all 9Show fewer
- 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
Trial locations and contacts
24 sites in 10 countries.
24 sites in 10 countries
United States5 sites
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
City of Hope
Duarte, California, 91010
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Australia4 sites
Austin Health
Heidelberg, Victoria, 3084
Alfred Health
Melbourne, Victoria, 3004
Monash Health
Melbourne, Victoria, 3168
Linear Clinical Research Ltd
Perth, Western Australia, 6009
France4 sites
Hopital Henri Mondor
Créteil, 94010
Claude Huriez Hospital
Lille, 59000
Centre Léon Bérard
Lyon, 69373 Cedex 08
Institut Curie
Saint-Cloud, 92210
Italy3 sites
IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant'Orsola
Bologna, 40138
lstituto Romagnolo per lo Studio dei Tumori "Dino Amadori" IRST
Meldola, FC, 47014
Ospedale Santa Maria delle Croci - AUSL della Romagna
Ravenna, 48121
South Korea3 sites
lnje University Busan Paik Hospital
Busan, 47392
Keimyung_University Dongsan Hospital
Daegu, 42601
Samsung Medical Center
Seoul, 06351
Germany1 site
Universitatsklinikum Koln, Klinik I fur lnnere Medizin
Cologne, North Rhine-Westphalia, 50937
Switzerland1 site
Ente Ospedaliero Cantonale (EOC) lstituto Oncologico della Svizzera italiana (IOSl)- Ospedale San Giovanni (ORBV)
Bellinzona, Canton Ticino, 6500
United Kingdom1 site
The Leeds Teaching Hospitals NHS Trust, St James University Hospital
Leeds, West Yorkshire, LS9 7TF
About this study
Official title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies
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 or venetoclax.
Read the detailed description
This is an open-label, multi-center, dose-escalation, Phase 1 study of PRT2527, a CDK9 inhibitor, as monotherapy for participants with relapsed and refractory lymphoid and myeloid malignancies, in combination with zanubrutinib, a Bruton tyrosine kinase inhibitor (BTKi) for participants with lymphoid malignancies, or in combination with venetoclax, a B-cell lymphoma 2 inhibitor (BCL-2i) in participants with myeloid malignancies. The study will be conducted in two parts, the dose escalation phase and the dose confirmation phase for both monotherapy and combination therapy. The dose escalation phase will evaluate escalating doses of PRT2527 as a monotherapy and in combination with zanubrutinib or venetoclax until MTD is identified or when the RP2D is determined. The dose confirmation phase will evaluate indication-specific cohorts at the RP2D to confirm the dose.
Approximately 274 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.
- Conditions
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Richter's Syndrome, T-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL)
- Being tested
- PRT2527, Zanubrutinib, Venetoclax
- Keywords
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, CDK9, Cyclin-Dependent Kinase 9, Hematologic Malignancies, Mantle Cell Lymphoma (MCL), PRT2527, Relapse/Refractory, Richter's Syndrome, T-cell Lymphoma (TCL), Zanubrutinib, Diffuse Large B-cell lymphoma (DLBCL), Venetoclax, Marginal Zone Lymphoma (MZL), Myeloid Malignancies, Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML), Myelodysplastic Syndrome (MDS), MDS/Myeloproliferative Neoplasm (MPN) Overlap Syndrome
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell, Lymphoma, T-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, B-Cell, Marginal Zone, Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT2527Drug
PRT2527 will be administered by intravenous infusion once weekly.
ZanubrutinibDrug
Zanubrutinib will be provided in capsules for oral administration once or twice daily.
VenetoclaxDrug
Venetoclax will be provided in tablet for oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| PRT2527 Monotherapy in Lymphoid Malignancies | Experimental | PRT2527 will be administered by intravenous infusion once weekly 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. Receives: Drug: PRT2527 |
| PRT2527/Zanubrutinib Combination in Lymphoid Malignancies | Experimental | PRT2527 will be administered by intravenous infusion once weekly 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 or twice daily. Receives: Drug: PRT2527; Drug: Zanubrutinib |
| PRT2527 Monotherapy in Myeloid Malignancies | Experimental | PRT2527 will be administered by intravenous infusion once weekly 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. Receives: Drug: PRT2527 |
| PRT2527/Venetoclax Combination in Myeloid Malignancies | Experimental | PRT2527 will be administered by intravenous infusion once weekly 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.
Venetoclax will be administered orally as a combination therapy once daily. Receives: Drug: PRT2527; Drug: Venetoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) of PRT2527
Dose limiting toxicities will be evaluated during Cycle 1 depending on the treatment arm and intrapatient ramp-up.
Measured: Baseline through Day 21, 28, or 35 days.
Safety and tolerability of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: AEs, CTCAE Assessments
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)
Measured: Baseline through approximately 2 years
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax
The MTD/RP2D will be established for further investigation in participants with relapsed or refractory hematologic malignancies
Measured: Baseline through approximately 2 years
Secondary outcomes (5)
Anti-tumor activity of PRT2527 as monotherapy and in combination with zanubrutinib or venetoclax: Objective response rate (ORR)
Best overall response as assessed by the investigator in accordance with standard disease-specific criteria for the hematologic malignancies under study
Measured: Baseline through approximately 2 years
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Duration of response/Complete Response (DOR/DoCR)
Duration from time of first observed response 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
Measured: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Maximum observed plasma concentration
PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration (Cmax)
Measured: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Area under the curve
PRT2527 pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
Measured: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Time of maximum concentration
PRT2527 pharmacokinetics will be calculated including the time of maximum concentration (Tmax)
Measured: Baseline through approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start12 Sep 2023
- Primary completion12 Jun 2025
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prelude Therapeutics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BeiGene
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665530
- Sponsor's protocol ID
- PRT2527-02
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With Relapsed/Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05665530
- Acronym / sponsor ID
- PRT2527-02
- Conditions
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL), Richter's Syndrome, T-cell Lymphoma, Diffuse Large B-cell Lymphoma (DLBCL)
- Keywords
- Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, CDK9, Cyclin-Dependent Kinase 9, Hematologic Malignancies, Mantle Cell Lymphoma (MCL), PRT2527, Relapse/Refractory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Prelude Therapeutics IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- BeiGene
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 or venetoclax.
Detailed description
This is an open-label, multi-center, dose-escalation, Phase 1 study of PRT2527, a CDK9 inhibitor, as monotherapy for participants with relapsed and refractory lymphoid and myeloid malignancies, in combination with zanubrutinib, a Bruton tyrosine kinase inhibitor (BTKi) for participants with lymphoid malignancies, or in combination with venetoclax, a B-cell lymphoma 2 inhibitor (BCL-2i) in participants with myeloid malignancies. The study will be conducted in two parts, the dose escalation phase and the dose confirmation phase for both monotherapy and combination therapy. The dose escalation phase will evaluate escalating doses of PRT2527 as a monotherapy and in combination with zanubrutinib or venetoclax until MTD is identified or when the RP2D is determined. The dose confirmation phase will evaluate indication-specific cohorts at the RP2D to confirm the dose.
Approximately 274 participants will be enrolled in the dose escalation and indication-specific, dose confirmation cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PRT2527 Monotherapy in Lymphoid Malignancies | Experimental | Drug: PRT2527PRT2527 will be administered by intravenous infusion once weekly 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. |
| PRT2527/Zanubrutinib Combination in Lymphoid Malignancies | Experimental | Drug: PRT2527, Drug: ZanubrutinibPRT2527 will be administered by intravenous infusion once weekly 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 or twice daily. |
| PRT2527 Monotherapy in Myeloid Malignancies | Experimental | Drug: PRT2527PRT2527 will be administered by intravenous infusion once weekly 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. |
| PRT2527/Venetoclax Combination in Myeloid Malignancies | Experimental | Drug: PRT2527, Drug: VenetoclaxPRT2527 will be administered by intravenous infusion once weekly 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. Venetoclax will be administered orally as a combination therapy once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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, MZL, or CLL/SLL (including Richter's syndrome) based on local testing, or TCL (monotherapy only), AML, CMML, MDS, or MDS/MPN overlap syndrome that have relapsed or become refractory to or be ineligible for standard-of-care therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2.
- Adequate organ function (hematology, renal, and hepatic)
- Echocardiogram (or multigated acquisition [MUGA] scan) indicating a left ventricular ejection fraction of ≥ 50%
Key exclusion criteria (9 listed)
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT2527PRT2527 will be administered by intravenous infusion once weekly. | Drug | PRT2527 Monotherapy in Lymphoid Malignancies, PRT2527 Monotherapy in Myeloid Malignancies, PRT2527/Venetoclax Combination in Myeloid Malignancies, PRT2527/Zanubrutinib Combination in Lymphoid Malignancies |
| ZanubrutinibZanubrutinib will be provided in capsules for oral administration once or twice daily. | Drug | PRT2527/Zanubrutinib Combination in Lymphoid Malignancies |
| VenetoclaxVenetoclax will be provided in tablet for oral administration once daily | Drug | PRT2527/Venetoclax Combination in Myeloid Malignancies |
Primary outcome
Dose limiting toxicity (DLT) of PRT2527
Time frame: Baseline through Day 21, 28, or 35 days.
Dose limiting toxicities will be evaluated during Cycle 1 depending on the treatment arm and intrapatient ramp-up.
Safety and tolerability of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: AEs, CTCAE Assessments
Time frame: Baseline through approximately 2 years
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)
Maximum tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax
Time frame: Baseline through approximately 2 years
The MTD/RP2D will be established for further investigation in participants with relapsed or refractory hematologic malignancies
5 secondary outcomes
Anti-tumor activity of PRT2527 as monotherapy and in combination with zanubrutinib or venetoclax: Objective response rate (ORR)
Time frame: Baseline through approximately 2 years
Anti-tumor activity of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Duration of response/Complete Response (DOR/DoCR)
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Maximum observed plasma concentration
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Area under the curve
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT2527 monotherapy and in combination with zanubrutinib or venetoclax: Time of maximum concentration
Time frame: Baseline through approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT2527, Zanubrutinib and Venetoclax in people with Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Prelude Therapeutics Incorporated at 24 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Australia, France, Italy, South Korea and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity (DLT) of PRT2527 (time frame: Baseline through Day 21, 28, or 35 days.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.