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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06560645




Registration number
NCT06560645
Ethics application status
Date submitted
6/08/2024
Date registered
19/08/2024

Titles & IDs
Public title
A Study of PRT7732, an Oral SMARCA2 Degrader, in Patients With Advanced or Metastatic Solid Tumors With a SMARCA4 Mutation
Scientific 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
Secondary ID [1] 0 0
PRT7732-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Non-small Cell Lung Carcinoma 0 0
SMARCA4 Mutation 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PRT7732

Experimental: PRT7732 - 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.


Treatment: Drugs: PRT7732
PRT7732 capsules will be self-administered once daily at the dose-level assigned
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose Limiting toxicity (DLT) of PRT7732
Timepoint [1] 0 0
Baseline through Day 21
Primary outcome [2] 0 0
Safety and tolerability of PRT7732 as measured by incidence of DLTs
Timepoint [2] 0 0
Baseline through completion of study, an average of 2 years
Primary outcome [3] 0 0
Safety and tolerability of PRT7732 as measured by incidence of laboratory deviations
Timepoint [3] 0 0
Baseline through study completion, an average of 2 years
Primary outcome [4] 0 0
Safety and tolerability as measured by rates of dose modification due to AEs according to NCI CTCAE
Timepoint [4] 0 0
Baseline through study completion, an average of 2 years
Primary outcome [5] 0 0
Maximum tolerated dose (MTD) of PRT7732
Timepoint [5] 0 0
Baseline through study completion, an average of 2 years
Primary outcome [6] 0 0
Recommended dose for expansion (RDE) of PRT7732
Timepoint [6] 0 0
Baseline through study completion, an average of 2 years
Secondary outcome [1] 0 0
Efficacy of PRT7732
Timepoint [1] 0 0
Baseline through study completion, an average of 2 years
Secondary outcome [2] 0 0
Pharmacokinetic profile of PRT7732 as a single agent: Maximum observed plasma concentration
Timepoint [2] 0 0
Baseline through study completion, an average of 2 years
Secondary outcome [3] 0 0
Pharmacokinetic profile of PRT7732 as a single agent: Area under the curve
Timepoint [3] 0 0
Baseline through study completion, an average of 2 years
Secondary outcome [4] 0 0
Pharmacokinetic profile of PRT7732 as a single agent: Time of maximum concentration (Tmax) and half-life (T1/2)
Timepoint [4] 0 0
Baseline through study completion, an average of 2 years
Secondary outcome [5] 0 0
Pharmacodynamic effects of PRT7732 as a single agent
Timepoint [5] 0 0
Baseline through study completion, an average of 2 years

Eligibility
Key inclusion criteria
* 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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 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 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2027
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [2] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [3] 0 0
Monash Health - Clayton
Recruitment hospital [4] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
2576 - Bowral
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Virginia
Country [9] 0 0
Germany
State/province [9] 0 0
North Rhine-Westfalia
Country [10] 0 0
Germany
State/province [10] 0 0
Saxony
Country [11] 0 0
Japan
State/province [11] 0 0
Tokyo
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Gyeonggi-do
Country [13] 0 0
Korea, Republic of
State/province [13] 0 0
Seoul
Country [14] 0 0
Spain
State/province [14] 0 0
Barcelona
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Prelude Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact (Please Do Not Disclose Personal Information)
Address 0 0
Country 0 0
Phone 0 0
See Email
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06560645