Breast CancerPhase 1NCT07905001
A Phase 1/1b Study of PRT13722 in Participants With Advanced HR+/HER2- Breast Cancer
A Phase 1 study testing PRT13722, Fulvestrant and Abemaciclib in people with Breast Cancer and Hormone-receptor-positive Breast Cancer, run by Prelude Therapeutics Incorporated.
Trial summary
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- What is being tested?
- PRT13722, Fulvestrant and Abemaciclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2026to 31 Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 (including contraception requirements), and other study procedures.
- histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negative breast cancer
- Disease progression following prior standard therapy and eligible for the assigned study cohort
- Measurable or evaluable disease per RECIST v1.1
- Willingness to provide tumor tissue for biomarker analyses
- Eastern Cooperative Oncology Group performance status of 0-1
- Negative serum or urine pregnancy test and agree to use highly effective contraception or maintain true abstinence.
- Adequate organ function and bone marrow reserves (hematology, renal, and hepatic)
Who cannot join
- Untreated, symptomatic, or unstable brain metastases
- Symptomatic visceral disease at risk of imminent life-threatening complications
- Uncontrolled infection or significant concurrent medical conditions
- Clinically significant cardiovascular disease or prolonged QT syndrome
- Pregnancy or breastfeeding
- Prior treatment with a KAT6-targeting agent
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- Recent anticancer therapy, radiotherapy, or major surgery
- Use of prohibited concomitant medications, including strong CYP3A4 inhibitors or inducers, proton pump inhibitors, P-gp inhibitors or inducers, and breast cancer resistance protein inhibitors
- Participation in another interventional clinical study
- Any condition that would interfere with study participation or evaluation of study results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Study Contact (Please Do Not Disclose Personal Information) contact
About this study
Official title: A Phase 1/1b, First-in-Human, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PRT13722, a KAT6A Protein Degrader, as Monotherapy and in Combination With Endocrine and Targeted Therapy in Adults With Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. PRT13722 will be evaluated as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion (RDE) and evaluate preliminary clinical activity.
Read the detailed description
This is a first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of PRT13722, a selective oral KAT6A protein degrader, in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. The study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722 administered as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion and evaluate preliminary clinical activity.
The study is conducted in three parts:
Part 1: Monotherapy dose escalation and backfill cohorts. Part 2: Combination dose-escalation cohorts with fulvestrant, abemaciclib plus fulvestrant, and imlunestrant.
Part 3: Combination dose-expansion cohorts to further evaluate safety and preliminary efficacy at the selected dose levels.
Up to approximately 240 participants are planned for enrollment across the three parts of the study.
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer
- Being tested
- PRT13722, Fulvestrant, Abemaciclib, Imlunestrant
- Keywords
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer, Locally Advanced or Metastatic HR+/HER2- Breast Cancer, Metastatic Breast Cancer, PRT13722, Abemaciclib, Fulvestrant, Imlunestrant, KAT6A
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT13722Drug
PRT13722 is an investigational oral drug administered once daily at the assigned dose level.
FulvestrantDrug
Fulvestrant is an approved selective estrogen receptor degrader (SERD) administered on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, then once monthly as an intramuscular injection into the buttocks (gluteal muscle).
AbemaciclibDrug
Abemaciclib is an approved oral cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor administered twice daily and used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer.
ImlunestrantDrug
Imlunestrant is an approved oral SERD administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| PRT13722 Monotherapy | Experimental | Participants receive PRT13722 once daily as monotherapy. This arm includes dose-escalation (Part 1A) and backfill cohorts (Part 1B) evaluating PRT13722 in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer to support the selection of RDE. Receives: Drug: PRT13722 |
| PRT13722 + Fulvestrant | Experimental | Participants receive PRT13722 once daily in combination with fulvestrant. This study includes a dose-escalation (Part 2A) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3A) at the RDE. Receives: Drug: PRT13722; Drug: Fulvestrant |
| PRT13722 + Abemaciclib + Fulvestrant | Experimental | Participants receive PRT13722 once daily in combination with abemaciclib and fulvestrant. This study includes a dose-escalation (Part 2B) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3B) at the RDE. Receives: Drug: PRT13722; Drug: Fulvestrant; Drug: Abemaciclib |
| PRT13722 + Imlunestrant | Experimental | Participants receive PRT13722 once daily in combination with imlunestrant. This study includes a dose-escalation (Part 2C) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3C) at the RDE. Receives: Drug: PRT13722; Drug: Imlunestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Incidence of dose limiting toxicities, defined according to protocol-specified criteria
Measured: Through cycle 1 (28 days)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2)
Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Measured: Through study completion, an average of 2 years
Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3)
Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
Measured: Through study completion, an average of 2 years
Secondary outcomes (11)
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
Measured: Through study completion, an average of 2 years
Duration of Response
Time from first documented response to disease progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first.
Measured: Through study completion, an average of 2 years
Clinical Benefit Response
Proportion of patients with a best overall response of complete response, partial response, or durable stable disease (24 weeks or longer), as assessed by the investigator per RECIST v1.1
Measured: Through study completion, an average of 2 years
Progression-Free Survival
Time from the date of first dose of investigational product to the date of first documented disease progression, as assessed by the investigator per RECIST v1.1, or death due to any cause
Measured: Through study completion, an average of 2 years
Overall Survival
Time from the date of first dose of investigational product to death due to any cause
Measured: Through study completion, an average of 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] of PRT13722 as Monotherapy and in Combination (Parts 1B and 3)
Safety and tolerability will be evaluated by incidence of adverse events leading to dose modifications, treatment interruptions, treatment discontinuations, and clinically significant laboratory abnormalities graded according to NCI CTCAE, Version 6.0
Measured: Through study completion, an average of 2 years
Maximum Observed Plasma Concentration (Cmax)
Maximum observed plasma concentration will be calculated using non-compartmental analysis
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Time To Maximum Concentration (Tmax)
Time to maximum concentration will be calculated using non-compartmental analysis
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Terminal Elimination Half-life (T1/2)
Terminal elimination half-life will be calculated using non-compartmental analysis
Measured: Cycle 1 Day 1 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration-time curve will be calculated using non-compartmental analysis
Measured: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Steady State Trough Concentrations
Steady state trough concentrations will be calculated using non-compartmental analysis
Measured: Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2029 (estimated)
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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prelude Therapeutics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07905001
- Sponsor's protocol ID
- PRT13722-01
- Other IDs
- 2026-527825-37-00
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b, First-in-Human, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of PRT13722, a KAT6A Protein Degrader, as Monotherapy and in Combination With Endocrine and Targeted Therapy in Adults With Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07905001
- Acronym / sponsor ID
- PRT13722-01
- Conditions
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer
- Keywords
- Breast Cancer, Hormone-receptor-positive Breast Cancer, HER2-negative Breast Cancer, HR-positive Breast Cancer, HR+/HER2- Breast Cancer, Locally Advanced Breast Cancer, Locally Advanced or Metastatic HR+/HER2- Breast Cancer, Metastatic Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Prelude Therapeutics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 29 Oct 2026 (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 first-in-human, open-label, multicenter study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722, an oral KAT6A protein degrader, in adults with locally advanced or metastatic Hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) breast cancer. PRT13722 will be evaluated as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion (RDE) and evaluate preliminary clinical activity.
Detailed description
This is a first-in-human, open-label, multicenter, dose-escalation and dose-expansion study of PRT13722, a selective oral KAT6A protein degrader, in adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer. The study will evaluate the safety, tolerability, dose-limiting toxicities, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of PRT13722 administered as monotherapy and in combination with fulvestrant, abemaciclib plus fulvestrant, or imlunestrant to determine recommended dose(s) for expansion and evaluate preliminary clinical activity.
The study is conducted in three parts:
Part 1: Monotherapy dose escalation and backfill cohorts. Part 2: Combination dose-escalation cohorts with fulvestrant, abemaciclib plus fulvestrant, and imlunestrant.
Part 3: Combination dose-expansion cohorts to further evaluate safety and preliminary efficacy at the selected dose levels.
Up to approximately 240 participants are planned for enrollment across the three parts of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| PRT13722 Monotherapy | Experimental | Drug: PRT13722Participants receive PRT13722 once daily as monotherapy. This arm includes dose-escalation (Part 1A) and backfill cohorts (Part 1B) evaluating PRT13722 in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer to support the selection of RDE. |
| PRT13722 + Fulvestrant | Experimental | Drug: PRT13722, Drug: FulvestrantParticipants receive PRT13722 once daily in combination with fulvestrant. This study includes a dose-escalation (Part 2A) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3A) at the RDE. |
| PRT13722 + Abemaciclib + Fulvestrant | Experimental | Drug: PRT13722, Drug: Fulvestrant, Drug: AbemaciclibParticipants receive PRT13722 once daily in combination with abemaciclib and fulvestrant. This study includes a dose-escalation (Part 2B) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3B) at the RDE. |
| PRT13722 + Imlunestrant | Experimental | Drug: PRT13722, Drug: ImlunestrantParticipants receive PRT13722 once daily in combination with imlunestrant. This study includes a dose-escalation (Part 2C) in participants with locally advanced or metastatic HR-positive, HER2-negative breast cancer followed by dose-expansion (Part 3C) at the RDE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures.
- histological or cytological diagnosis of locally advanced or metastatic HR-positive/HER2-negative breast cancer
- Disease progression following prior standard therapy and eligible for the assigned study cohort
- Measurable or evaluable disease per RECIST v1.1
- Willingness to provide tumor tissue for biomarker analyses
Key exclusion criteria (10 listed)
- Untreated, symptomatic, or unstable brain metastases
- Symptomatic visceral disease at risk of imminent life-threatening complications
- Uncontrolled infection or significant concurrent medical conditions
- Clinically significant cardiovascular disease or prolonged QT syndrome
- Pregnancy or breastfeeding
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 |
|---|---|---|
| PRT13722PRT13722 is an investigational oral drug administered once daily at the assigned dose level. | Drug | PRT13722 + Abemaciclib + Fulvestrant, PRT13722 + Fulvestrant, PRT13722 + Imlunestrant, PRT13722 Monotherapy |
| FulvestrantFulvestrant is an approved selective estrogen receptor degrader (SERD) administered on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, then once monthly as an intramuscular injection into the buttocks (gluteal muscle). | Drug | PRT13722 + Abemaciclib + Fulvestrant, PRT13722 + Fulvestrant |
| AbemaciclibAbemaciclib is an approved oral cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor administered twice daily and used in combination with endocrine therapy for HR-positive, HER2-negative breast cancer. | Drug | PRT13722 + Abemaciclib + Fulvestrant |
| ImlunestrantImlunestrant is an approved oral SERD administered once daily. | Drug | PRT13722 + Imlunestrant |
Primary outcome
Dose limiting toxicity of PRT13722 (Parts 1A and 2)
Time frame: Through cycle 1 (28 days)
Incidence of dose limiting toxicities, defined according to protocol-specified criteria
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of PRT13722 as monotherapy and in combination (Parts 1A and 2)
Time frame: Through study completion, an average of 2 years
Safety and tolerability assessed by the number of participants with treatment-emergent adverse events, serious adverse events, adverse events leading to dose modification, treatment interruption, or treatment discontinuation, and clinically significant laboratory abnormalities. Adverse events and selected laboratory abnormalities will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 6.0
Preliminary Antitumor Activity: Objective Response Rate (Parts 1B and 3)
Time frame: Through study completion, an average of 2 years
Proportion of patients with best overall response of either complete response or partial response, as assessed by the investigator per RECIST v1.1
11 secondary outcomes
Preliminary Antitumor Activity: Objective Response Rate (Parts 1A and 2)
Time frame: Through study completion, an average of 2 years
Duration of Response
Time frame: Through study completion, an average of 2 years
Clinical Benefit Response
Time frame: Through study completion, an average of 2 years
Progression-Free Survival
Time frame: Through study completion, an average of 2 years
Overall Survival
Time frame: Through study completion, an average of 2 years
Incidence of Treatment-Emergent Adverse Events [Safety and tolerability] of PRT13722 as Monotherapy and in Combination (Parts 1B and 3)
Time frame: Through study completion, an average of 2 years
Maximum Observed Plasma Concentration (Cmax)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Time To Maximum Concentration (Tmax)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Terminal Elimination Half-life (T1/2)
Time frame: Cycle 1 Day 1 (each cycle is 28 days)
Area under the plasma concentration versus time curve (AUC)
Time frame: Cycle 1 Day 1, Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Steady State Trough Concentrations
Time frame: Cycle 1 Day 15, and Cycle 2 Day 1 (each cycle is 28 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 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.
Study Contact (Please Do Not Disclose Personal Information) contact
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT13722, Fulvestrant and Abemaciclib in people with Breast Cancer and Hormone-receptor-positive Breast Cancer, run by Prelude Therapeutics Incorporated.
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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Contact (Please Do Not Disclose Personal Information) (See Email, clinicaltrials@preludetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicity of PRT13722 (Parts 1A and 2) (time frame: Through cycle 1 (28 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 29 Oct 2026.