To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
NCT ID:
NCT06063681
Condition:
Advanced / Metastatic Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Refractory
Relapsing
Solid Tumors
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
The study will follow an accelerated titration dose (ATD) escalation scheme.
Single-subject cohorts will open sequentially when previous cohort milestones are met,
e.g. completion of the Dose-Limiting Toxicity (DLT) period.
If the single evaluable subject within an ATD cohort experiences a grade ≥ 2 toxicity
during the DLT period, the ATD scheme will stop and a traditional 3+3 design will be
implemented.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SR-8541A
Description:
orally administered ENPP1 inhibitor
Arm group label:
SR-8541A Monotherapy
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.
Detailed description:
SR-8541A, an ENPP1 inhibitor, will be administered orally as a monotherapy to assess
safety, tolerability, and pharmacokinetics (PK) in subjects with advanced/metastatic
solid tumors.
Subjects eligible for treatment include those whose disease is refractory to standard
therapeutic options, or for which there are no standard therapeutic options available.
All enrolled patients will orally administer SR-8541A daily. Treatment may continue until
the subject's disease worsens or another treatment discontinuation criterion is met.
Criteria for eligibility:
Criteria:
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
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Scientia Clinical Research Ltd
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Charlotte Lemech
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Amy Body
Facility:
Name:
Peninsula & South Eastern Haematology & Oncology Group
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Vinod Ganju
Start date:
October 12, 2023
Completion date:
August 2024
Lead sponsor:
Agency:
Stingray Therapeutics
Agency class:
Industry
Source:
Stingray Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06063681
