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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06063681




Registration number
NCT06063681
Ethics application status
Date submitted
23/09/2023
Date registered
2/10/2023
Date last updated
22/11/2023

Titles & IDs
Public title
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Scientific title
Phase 1, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study of SR-8541A (ENPP1 Inhibitor) Administered Orally as Monotherapy in Subjects With Advanced/Metastatic Solid Tumors
Secondary ID [1] 0 0
StingrayTx
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced / Metastatic Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR-8541A

Experimental: SR-8541A Monotherapy - SR-8541A will be orally administered.


Treatment: Drugs: SR-8541A
orally administered ENPP1 inhibitor
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency and severity of Adverse Events
Timepoint [1] 0 0
From first dose of study drug through 30 days following the last dose of study treatment
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RP2D) of SR-8541A
Timepoint [2] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [1] 0 0
Maximum plasma concentration (Cmax)
Timepoint [1] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [2] 0 0
Area under the curve from zero up to time t (AUC0-t)
Timepoint [2] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [3] 0 0
Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)
Timepoint [3] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [4] 0 0
Maximal time for peak concentration (Tmax)
Timepoint [4] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [5] 0 0
Terminal phase rate constant (?z)
Timepoint [5] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [6] 0 0
Half-life (t1/2)
Timepoint [6] 0 0
From first dose of study drug through 28 days following the first dose of study treatment
Secondary outcome [7] 0 0
Overall Response Rate
Timepoint [7] 0 0
From first dose of study drug through 2 years following first dose
Secondary outcome [8] 0 0
Progression Free Survival
Timepoint [8] 0 0
From first dose of study drug through 2 years following first dose
Secondary outcome [9] 0 0
Duration of Response
Timepoint [9] 0 0
From first dose of study drug through 2 years following first dose
Secondary outcome [10] 0 0
Disease Control Rate
Timepoint [10] 0 0
From first dose of study drug through 2 years following first dose
Secondary outcome [11] 0 0
Overall Survival
Timepoint [11] 0 0
From first dose of study drug through 2 years following first dose

Eligibility
Key inclusion criteria
1. Life expectancy of at least 3 months
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
3. Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.
4. Measurable disease per RECIST v1.1
5. Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
6. Adequate hematologic, renal and hepatic function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Primary central nervous system (CNS) tumor
2. Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
3. Continuous systemic treatment with either corticosteroids (>10 milligram [mg] daily prednisone equivalents) or other immunosuppressive medications within 28 days
4. Active autoimmune disease that has required systemic treatment in past 2 years
5. History of documented congestive heart failure (New York Heart Association [NYHA] class II - IV); unstable angina; poorly controlled hypertension; clinically significant valvular heart disease; high-risk uncontrolled arrhythmias (including sustained ventricular tachycardia); myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within the last 6 months, or Canadian Cardiovascular Society angina class > 2
6. Troponin I > ULN
7. Blood pressure (BP) - Systolic < 95 mmHg or > 160 mmHg or diastolic > 100 mmHg
8. Resting heart rate (HR) > 100 beats per minute (BPM)
9. Corrected QT interval by Fridericia (QTcF) = 470 ms
10. Left Ventricular Ejection Fraction (LVEF) < 50%
11. Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months
12. Leptomeningeal disease
13. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for at least 8 weeks
14. Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment
15. Prior additional malignancy that is progressing or has received treatment the previous 3 years
16. Active infection requiring systemic treatment
17. Positive for human immunodeficiency virus (HIV) (HIV antibodies) or active hepatitis B (e.g., HbsAg reactive) or active hepatitis C (e.g., HCV ribonucleic acid [RNA] qualitative) infection with detectable viral load
18. Major surgery within 28 days prior to Day 1 and/or minor surgery (excluding biopsy) within 7 days

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
12/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
Peninsula & South Eastern Haematology & Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
3199 - Frankston

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A, an ENPP1 inhibitor, administered orally as a monotherapy in subjects with solid tumors.
Trial website
https://clinicaltrials.gov/study/NCT06063681
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
Monil Shah
Address 0 0
Country 0 0
Phone 0 0
201-978-8032
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06063681