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SarcomaPhase 1NCT05159518

A Study of PRT2527 in Participants With Advanced Solid Tumors

A Phase 1 study testing PRT2527 in people with Sarcoma and Castrate Resistant Prostate Cancer, run by Prelude Therapeutics Incorporated at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PRT2527
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
8 sitesUnited States
Study dates
14 Feb 2022to 6 Dec 2023
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

  • Tumor types under study
  • Selected sarcomas with a documented gene fusion
  • Castrate resistant prostate cancer (CRPC)
  • Hormone receptor positive (HR+), HER2 negative (HER2-) breast cancer
  • Non-small cell lung cancer (NSCLC)
  • MYC amplified solid tumors
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  • Must have measurable disease per RECIST 1.1; participants with CRPC or sarcoma may have nonmeasurable but evaluable disease
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
  • Adequate organ function
  • Must provide tumor tissue sample to the central laboratory for biomarker analysis
  • Participants must have recovered from the effects of prior cancer-related therapy, radiotherapy, or surgery to ≤ Grade 1

Who cannot join

  • Primary malignancies of the CNS, or uncontrolled CNS metastases, including impending spinal cord compression
  • have a corrected QT interval >480 msec from prior or baseline
  • have impaired cardiac function or clinically significant cardiac disease
  • Treatment with strong inhibitors or inducers of CYP3A4
  • Prior exposure to a CDK9 inhibitor
  • History of another malignancy except for:
Show all 11Show fewer
  • Curatively treated malignancy with no known active disease
  • Curatively treated non-melanoma skin cancer without evidence of disease
  • Curatively treated carcinoma in situ without evidence of disease
  • have undergone major surgery within 2 weeks prior to Week 1 Day 1
  • have had chemotherapy, biologic therapy, targeted therapy, immunotherapy, extended-field radiotherapy, or investigational agents within 5 half-lives or 28 days (whichever is shorter) prior to administration of the first dose of study drug on Week 1 Day 1.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Investigational Drug Services, AdventHealth Celebration

    Celebration, Florida, 34747

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multicenter, Dose Escalation and Confirmation Study of PRT2527 in Participants With Advanced Solid Tumors

This is a Phase 1 dose-escalation and confirmation study of PRT2527, a Cyclin-dependent Kinase 9 (CDK9) inhibitor, in participants with advanced solid tumors. The purpose of this study is to define the dosing schedule, and maximally tolerated dose to be used in subsequent development of PRT2527.

Read the detailed description

This is a multicenter, open-label, dose-escalation and confirmation Phase 1 study of PRT2527, a CDK9 inhibitor, evaluating participants with selected advanced/metastatic sarcomas displaying a documented gene fusion, castrate resistant prostate cancer, hormone receptor positive HER2-negative breast cancer, advanced/metastatic non-small cell lung cancer, and solid tumors displaying MYC amplification. The study plan expects to evaluate approximately six dose levels of approximately 1-6 participants per dose level; however additional and/or intermediate dose levels may be explored. Taking into account pharmacokinetic and pharmacodynamic data from the preceding dose levels, the dose may be escalated until a dose limiting toxicity is identified. The total sample size will be approximately 30 patients for MTD and RP2D determination.

Being tested
PRT2527
Keywords
Breast Cancer, Castrate Resistant Prostate Cancer, CDK9 Inhibitor, CRPC, Cyclin-dependent Kinase 9, Hormone Receptor Positive HER2 Negative Breast Cancer, HR+/HER2- Breast Cancer, Non-small Cell Lung Cancer, NSCLC, Prostate Cancer, PRT2527, Refractory Solid Tumors, Relapsed Solid Tumors, Sarcoma
Medical subject headings
Sarcoma, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Prostatic Neoplasms

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

Study groups in NCT05159518
Study groupRoleWhat they receive
PRT2527ExperimentalPRT2527 will be administered by intravenous infusion
Receives: Drug: PRT2527

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose limiting toxicities (DLT) of PRT2527

    Dose limiting toxicities will be evaluated over the 21-day observation period

    Measured: Baseline through Day 21

  2. Maximally tolerated dose (MTD) of PRT2527

    The MTD will be established for further investigation in participants with advanced solid tumors

    Measured: Baseline through approximately 1 year

  3. Recommended phase 2 dose (RP2D) and schedule of PRT2527

    The RP2D will be established for further investigation in participants with advanced solid tumors

    Measured: Baseline through approximately 1 year

Secondary outcomes (4)

  1. Safety and tolerability of PRT2527: AEs, SAEs, CTCAE assessments

    Safety and tolerability will be assessed by recording adverse events (AEs) and serious adverse events (SAEs) according to Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: Baseline through approximately 2 years

  2. Pharmacokinetic profile of PRT2527: maximum observed plasma concentration

    PRT2527 pharmacokinetics will be calculated including the maximum observed plasma concentration

    Measured: Baseline through approximately 1 year

  3. Anti-tumor activity of PRT2527: measurement of objective responses

    Anti-tumor activity of PRT2527 based on the measurement of objective responses to PRT2527 according to the disease-specific response criteria for patients with advanced solid tumors

    Measured: Baseline through approximately 2 years

  4. Duration of response to PRT2527: Objective responses

    Duration of response will be calculated for all patients eligible for response determination from the time that a response is first observed until progression or death, whichever occurs first

    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.

  1. First posted16 Dec 2021
  2. Study start14 Feb 2022
  3. Primary completion6 Dec 2023
  4. Study completion6 Dec 2023

Resources

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05159518
Sponsor's protocol ID
PRT2527-01
Status last verified
Dec 2023
First submitted
2 Dec 2021
Last updated
11 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRT2527 in people with Sarcoma and Castrate Resistant Prostate Cancer, run by Prelude Therapeutics Incorporated at 8 sites in United States.

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 11 inclusion and 11 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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 toxicities (DLT) of PRT2527 (time frame: Baseline through Day 21). 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?

On the ClinicalTrials.gov record for NCT05159518.

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 11 Dec 2023.

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