Advanced Solid TumorPhase 1NCT06560645
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
A Phase 1 study testing PRT7732 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Prelude Therapeutics Incorporated at 28 sites in 6 countries.
Trial summary
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Carcinoma
- What is being tested?
- PRT7732
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 4 Nov 2024to 28 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 (including contraception requirements), and other study procedures
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 by local testing that has either progressed on or is ineligible for standard of care therapy
- Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing to provide either archival or fresh tumor tissue sample
- Adequate organ function (hematology, renal, and hepatic)
Who cannot join
- Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
- Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
- History of other malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, prostate adenocarcinoma with Gleason score of 3+3 or less, carcinoma in situ of the cervix, or other non-invasive 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
- Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States11 sites
UNC Hospitals, The University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
University of Virginia Comprehensive Cancer Center
Charlottesville, Virginia, 22903
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Brigitte Harris Cancer Pavilion
Detroit, Michigan, 48202
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
SCRI Oncology Partners
Nashville, Tennessee, 37203
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, 10065
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Oregon Health & Science University
Portland, Oregon, 97239
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94158
Australia5 sites
Border Medical Oncology Research Unit
Albury, New South Wales, 2640
Southern Highlands Cancer Centre
Bowral, New South Wales, 2576
Monash Health
Clayton, Victoria, 3168
Linear Clinical Research Ltd
Nedlands, Western Australia, 6009
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Japan4 sites
National Cancer Center Hospital
Chuo Ku, Tokyo, 104-0045
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, 135-8550
Kindai University Hospital
Sayama, Osaka, 589-8511
The Univerity of Osaka Hospital
Suita, Osaka, 565-0871
South Korea3 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Severance Hospital, Yonsei University Health System
Seoul, 03722
Samsung Medical Center
Seoul, 06351
Spain3 sites
Hospital Universitario Vall d'Hebron
Barcelona, 08035
Start Madrid-FJD, Hospital Universitario Fundacion Jimenez Diaz-Servicio de Oncologia
Madrid, 28040
Hospital Universitario HM Sanchinarro
Madrid, 28050
Germany2 sites
University Clinic Cologne, Clinic for Internal Medicine
Cologne, North Rhine-Westfalia, 50937
Technische Universitat Dresden, Medizinlsche Fakultat Carl Gustav Carus Nationales Centrum fur Tumorerkrankungen Dresden, Early Clinical Trial Unit (NCT/UCC ECTU)
Dresden, Saxony, 01307
About this study
Official title: A Phase 1 Open-Label, Multi-Center, Safety and Efficacy Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4
This is a Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.
Read the detailed description
This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Carcinoma, SMARCA4 Mutation, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- Being tested
- PRT7732
- Keywords
- Advanced Solid Tumors, BRG1, BRM, Degrader, Metastatic Solid Tumors, Non-Small Cell Lung Cancers, NSCLC, PRT7732, SMARCA2, SMARCA4, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma, Gastric Adenocarcinoma, Gastric Squamous Cell Carcinoma, Gastroesophageal Junction Adenocarcinoma, Gastroesophageal Junction Squamous Cell Carcinoma
- Medical subject headings
- Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT7732Drug
PRT7732 capsules will be self-administered once daily at the dose-level assigned
| Study group | Role | What they receive |
|---|---|---|
| PRT7732 | Experimental | PRT7732 is administered as an oral capsule once daily. Dose escalation/de-escalation decisions will be guided by the BLRM method until the RDE is determined. Receives: Drug: PRT7732 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting toxicity (DLT) of PRT7732
Incidence of dose limiting toxicities for patients in the dose escalation phase
Measured: Baseline through Day 21
Safety and tolerability of PRT7732 as measured by incidence of DLTs
Safety and tolerability will be evaluated by incidence of DLTs
Measured: Baseline through completion of study, an average of 2 years
Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations
Safety and tolerability will be evaluated by laboratory measurements
Measured: Baseline through study completion, an average of 2 years
Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE
Safety and tolerability will be evaluated by 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 study completion, an average of 2 years
Maximum tolerated dose (MTD) of PRT7732
Maximum tolerated dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Measured: Baseline through study completion, an average of 2 years
Recommended dose for expansion (RDE) of PRT7732
The RDE will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Measured: Baseline through study completion, an average of 2 years
Secondary outcomes (5)
Efficacy of PRT7732
Best overall response of either complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1
Measured: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration
Pharmacokinetics will be calculated including the maximum observed plasma concentration
Measured: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve
Pharmacokinetics will be calculated including the area under the plasma concentration versus time curve (AUC)
Measured: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2)
Pharmacokinetic parameters will be calculated using standard non-compartmental techniques
Measured: Baseline through study completion, an average of 2 years
Pharmacodynamic effects of PRT7732 as a single agent
The pharmacodynamic effect of PRT7732 demonstrating target engagement by assessment of SMARCA2 protein in peripheral blood mononuclear cells and tumor tissue as assessed by reduction in protein levels of SMARCA2 in peripheral blood mononuclear cells and/or tumor tissue
Measured: Baseline through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start4 Nov 2024
- Primary completion28 Jan 2026
- Study completion28 Jan 2026
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 42 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
- NCT06560645
- Sponsor's protocol ID
- PRT7732-01
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2024
- Last updated
- 2 Feb 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 2 Feb 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 PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4
- ClinicalTrials.gov ID
- NCT06560645
- Acronym / sponsor ID
- PRT7732-01
- Conditions
- Advanced Solid Tumor, Metastatic Solid Tumor, Non-small Cell Lung Carcinoma, SMARCA4 Mutation, Esophageal Adenocarcinoma, Esophageal Squamous Cell Carcinoma
- Keywords
- Advanced Solid Tumors, BRG1, BRM, Degrader, Metastatic Solid Tumors, Non-Small Cell Lung Cancers, NSCLC, PRT7732
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Prelude Therapeutics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 28 Jan 2026 (actual)
- Study completion
- 28 Jan 2026 (actual)
- First posted
- 19 Aug 2024 (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 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation.
Detailed description
This is an open-label, multi-center, first-in-human, Phase 1 study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PRT7732 an oral SMARCA degrader in patients with select advanced or metastatic solid tumors with a SMARCA4 mutation. Approximately 104 participants will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRT7732 | Experimental | Drug: PRT7732PRT7732 is administered as an oral capsule once daily. Dose escalation/de-escalation decisions will be guided by the BLRM method until the RDE is determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations (including contraception requirements), and other study procedures
- Histologically confirmed advanced, recurrent, or metastatic solid tumor malignancy with any mutation of SMARCA4 by local testing that has either progressed on or is ineligible for standard of care therapy
- Must have measurable or non-measurable (but evaluable) disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Willing to provide either archival or fresh tumor tissue sample
Key exclusion criteria (4 listed)
- Participants with solid tumors with known concomitant SMARCA2 mutation or loss of protein expression
- Clinically significant or uncontrolled cardiac disease, uncontrolled electrolyte disorders, uncontrolled or symptomatic central nervous system (CNS) metastases or leptomeningeal disease
- History of other malignancy within 3 years except for adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, prostate adenocarcinoma with Gleason score of 3+3 or less, carcinoma in situ of the cervix, or other non-invasive 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
- Receipt of any targeted therapy directed against BRM/BRG1 (SMARCA2/SMARCA4).
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 |
|---|---|---|
| PRT7732PRT7732 capsules will be self-administered once daily at the dose-level assigned | Drug | PRT7732 |
Primary outcome
Dose Limiting toxicity (DLT) of PRT7732
Time frame: Baseline through Day 21
Incidence of dose limiting toxicities for patients in the dose escalation phase
Safety and tolerability of PRT7732 as measured by incidence of DLTs
Time frame: Baseline through completion of study, an average of 2 years
Safety and tolerability will be evaluated by incidence of DLTs
Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations
Time frame: Baseline through study completion, an average of 2 years
Safety and tolerability will be evaluated by laboratory measurements
Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE
Time frame: Baseline through study completion, an average of 2 years
Safety and tolerability will be evaluated by 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) of PRT7732
Time frame: Baseline through study completion, an average of 2 years
Maximum tolerated dose will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
Recommended dose for expansion (RDE) of PRT7732
Time frame: Baseline through study completion, an average of 2 years
The RDE will be determined by the sponsor based on the Safety Review Committee's recommendation considering the totality of the available clinical safety, clinical efficacy, pharmacokinetics (PK), and pharmacodynamic data
5 secondary outcomes
Efficacy of PRT7732
Time frame: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration
Time frame: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve
Time frame: Baseline through study completion, an average of 2 years
Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2)
Time frame: Baseline through study completion, an average of 2 years
Pharmacodynamic effects of PRT7732 as a single agent
Time frame: Baseline through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 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.
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT7732 in people with Advanced Solid Tumor and Metastatic Solid Tumor, run by Prelude Therapeutics Incorporated at 28 sites in 6 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 6 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Australia, Japan, South Korea, Spain and 1 more country. 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 was stopped early (reason given: Sponsor decision). Results are not available in the source record.
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 PRT7732 (time frame: Baseline through Day 21). The study lists 6 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 2 Feb 2026.