Breast CancerPhase 1NCT05538572
A Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
A Phase 1 study testing PRT3645 in people with Breast Cancer and Glioblastoma, run by Prelude Therapeutics Incorporated at 13 sites in 2 countries.
Trial summary
This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and recommended phase 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Glioblastoma, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- PRT3645
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 27 Dec 2022to 26 Jun 2024
- 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
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:
- HR+ and HER2- or HR+ and HER2+ breast cancer
- Recurrent GBM (IDH wild type) or CDKN2A/B homozygous deleted IDH-mutant astrocytoma
- KRAS-mutant or SMARCA4 loss NSCLC
- CDK pathway alternation in any of the following tumor types: malignant mesothelioma, HPV-negative HNSCC (including oral cavity, oropharynx, hypopharynx, and larynx), sarcoma, or NSCLC
- Estrogen receptor positive with TP53 wild type endometrial cancer
Show all 12Show fewer
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- Must have measurable or non-measureable (but evaluable) disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) ≥80% (KPS is for GBM only)
- Adequate organ function.
- Able to swallow and retain oral medication.
- Must provide either archival or fresh tumor tissue sample during screening.
Who cannot join
- Participants with advanced, symptomatic, extensive visceral disease.
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, any upper gastrointestinal surgery including gastric resection, known malabsorption syndrome, or other condition that may impair absorption of PRT3645.
- Treatment with strong inhibitors of CYP3A4.
- History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study.
- Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM.
- Endometrial cancer patients who had received prior treatment with a CDK 4/6 inhibitor.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
AdventHealth Medical Group Oncology Research at Celebration
Celebration, Florida, 34747
Cleveland Clinic
Cleveland, Ohio, 44195
NEXT Virginia
Fairfax, Virginia, 22031
Miami Cancer Institute
Miami, Florida, 33176
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
Laura and Isaac Perlmutter Cancer Center/ NYU Langone Health
New York, New York, 10016
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, 78229
Florida Cancer Specialists
Sarasota, Florida, 34232
About this study
Official title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
This is a Phase 1 dose-escalation study of PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and recommended phase 2 dose to be used in subsequent development of PRT3645.
Read the detailed description
This is an open-label, multicenter, dose-escalation Phase 1 study of PRT3645, a CDK4/6 inhibitor, evaluating patients with selected advanced or metastatic solid tumors including breast cancer (BC), glioblastoma (GBM), non-small cell lung cancer (NSCLC), sarcomas, head and neck squamous cell carcinoma (HNSCC), malignant mesothelioma, and endometrial cancer. The study plan expects to evaluate approximately eight dose levels however additional 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. Up to 15 patients may be enrolled at a dose shown to be tolerated for confirmation of the MTD and/or RP2D.
- Conditions
- Breast Cancer, Glioblastoma, Head and Neck Squamous Cell Carcinoma, Malignant Mesothelioma, Non-small Cell Lung Cancers, Sarcoma
- Being tested
- PRT3645
- Keywords
- Advanced Solid Tumors, Breast Cancer, CDK4/6, Cyclin-dependent Kinase 4, Cyclin-dependent Kinase 6, Glioblastoma, Head and Neck Squamous Cell Carcinoma, HNSCC, Malignant Mesothelioma, Metastatic Solid Tumors, Non-small Cell Lung Cancers, NSCLC, PRT3645, Sarcoma, Endometrial Cancer
- Medical subject headings
- Breast Neoplasms, Glioblastoma, Squamous Cell Carcinoma of Head and Neck, Mesothelioma, Malignant, Sarcoma, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT3645Drug
PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned
| Study group | Role | What they receive |
|---|---|---|
| PRT3645 | Experimental | PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned Receives: Drug: PRT3645 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity (DLT) of PRT3645
Dose limiting toxicity will be evaluated over the 28-day observation period
Measured: Baseline through Day 28
Safety and tolerability of PRT3645: AEs, CTCAE Assessments
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Baseline through approximately 2 years
Maximally tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT3645
The MTD/RP2D will be established for further investigation in participants with advanced solid tumors
Measured: Baseline through approximately 2 years
Secondary outcomes (3)
Efficacy of PRT3645: Tumor assessment and responses
Objective response rate (ORR), Progression-free survival (PFS), Disease control rate (DCR) and Duration of response (DOR) will use RECIST v1.1, mRECIST v1.1, and/or RANO as primary measure for tumor assessment and response.
Measured: Baseline through approximately 2 years
Pharmacokinetic profile of PRT3645: Minimum and maximum observed plasma concentration
PRT3645 pharmacokinetics will be calculated including the minimum and maximum observed plasma concentration.
Measured: Baseline through approximately 2 years
Pharmacodynamic effect of PRT3645: Target engagement
Pharmacodynamic effect of PRT3645 demonstrating target engagement by assessment of phosphorylation of Rb.
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 posted14 Sep 2022
- Study start27 Dec 2022
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prelude Therapeutics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538572
- Sponsor's protocol ID
- PRT3645-01
- Status last verified
- Jun 2024
- First submitted
- 9 Sep 2022
- Last updated
- 1 Jul 2024
- 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 1 Jul 2024. 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 PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05538572
- Acronym / sponsor ID
- PRT3645-01
- Conditions
- Breast Cancer, Glioblastoma, Head and Neck Squamous Cell Carcinoma, Malignant Mesothelioma, Non-small Cell Lung Cancers, Sarcoma
- Keywords
- Advanced Solid Tumors, Breast Cancer, CDK4/6, Cyclin-dependent Kinase 4, Cyclin-dependent Kinase 6, Glioblastoma, Head and Neck Squamous Cell Carcinoma, HNSCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Prelude Therapeutics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 14 Sep 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 PRT3645, a Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, in patients with advanced or metastatic solid tumors. The purpose of this study is to investigate the safety, tolerability, dose limiting toxicity, and to determine maximally tolerated dose and recommended phase 2 dose to be used in subsequent development of PRT3645.
Detailed description
This is an open-label, multicenter, dose-escalation Phase 1 study of PRT3645, a CDK4/6 inhibitor, evaluating patients with selected advanced or metastatic solid tumors including breast cancer (BC), glioblastoma (GBM), non-small cell lung cancer (NSCLC), sarcomas, head and neck squamous cell carcinoma (HNSCC), malignant mesothelioma, and endometrial cancer. The study plan expects to evaluate approximately eight dose levels however additional 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. Up to 15 patients may be enrolled at a dose shown to be tolerated for confirmation of the MTD and/or RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRT3645 | Experimental | Drug: PRT3645PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy that have either progress or ineligible for standard of care therapy:
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
- Must have measurable or non-measureable (but evaluable) disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 or Karnofsky Performance Status (KPS) ≥80% (KPS is for GBM only)
- Adequate organ function.
Key exclusion criteria (6 listed)
- Participants with advanced, symptomatic, extensive visceral disease.
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, any upper gastrointestinal surgery including gastric resection, known malabsorption syndrome, or other condition that may impair absorption of PRT3645.
- Treatment with strong inhibitors of CYP3A4.
- History of another malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancies, or malignancies previously treated with curative intent and not on active therapy or expected to require treatment or recurrence during the study.
- Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic CNS metastases or leptomeningeal disease except for GBM.
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 |
|---|---|---|
| PRT3645PRT3645 capsules will be self-administered once daily, continuously, at the dose-level assigned | Drug | PRT3645 |
Primary outcome
Dose limiting toxicity (DLT) of PRT3645
Time frame: Baseline through Day 28
Dose limiting toxicity will be evaluated over the 28-day observation period
Safety and tolerability of PRT3645: AEs, CTCAE Assessments
Time frame: Baseline through approximately 2 years
Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Maximally tolerated dose (MTD)/Recommended phase 2 dose (RP2D) of PRT3645
Time frame: Baseline through approximately 2 years
The MTD/RP2D will be established for further investigation in participants with advanced solid tumors
3 secondary outcomes
Efficacy of PRT3645: Tumor assessment and responses
Time frame: Baseline through approximately 2 years
Pharmacokinetic profile of PRT3645: Minimum and maximum observed plasma concentration
Time frame: Baseline through approximately 2 years
Pharmacodynamic effect of PRT3645: Target engagement
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 1 Jul 2024.
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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.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT3645 in people with Breast Cancer and Glioblastoma, run by Prelude Therapeutics Incorporated at 13 sites in 2 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 12 inclusion and 6 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 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Singapore. 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 PRT3645 (time frame: Baseline through Day 28). 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 1 Jul 2024.