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New treatment option for Advanced / Metastatic Solid Tumor
Official title A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06063681
What this study is testing
What is SR-8541A?
SR-8541A is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for advanced / metastatic solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint inhibitor (ICI) in subjects with solid tumors.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no...
- Measurable disease per RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
You likely can't join if
- Primary central nervous system (CNS) tumor
- Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic treatment with either corticosteroids (\>10 milligram [mg] daily prednisone equivalents) or other immunosuppressive medications...
- Active autoimmune disease that has required systemic treatment in past 2 years
- History of documented congestive heart failure (New York Heart Association [NYHA] class II - IV); unstable angina; poorly controlled hypertension...
- Troponin I \> ULN
See the full eligibility criteria
- Life expectancy of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
- Histopathologically/cytologically confirmed advanced solid tumor, which is refractory to standard therapeutic options, or for which there are no standard therapeutic options.
- Measurable disease per RECIST v1.1
- Willing to provide archival or fresh tumor tissue during screening (required) and post-treatment (optional)
- Adequate hematologic, renal and hepatic function
- Primary central nervous system (CNS) tumor
- Prior systemic anti-cancer treatment including other investigational agents, surgery, or radiation within 28 days or 5 half-lives, whichever is less
- Continuous systemic treatment with either corticosteroids (\>10 milligram [mg] daily prednisone equivalents) or other immunosuppressive medications within 28 days
- Active autoimmune disease that has required systemic treatment in past 2 years
- 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...
- Troponin I \> ULN
- Blood pressure (BP) - Systolic \ 160 mmHg or diastolic \> 100 mmHg
- Resting heart rate (HR) \> 100 beats per minute (BPM)
- Corrected QT interval by Fridericia (QTcF) ≥ 470 ms
- Left Ventricular Ejection Fraction (LVEF) \< 50%
- Symptomatic uncontrolled CNS disease requiring treatment with steroids or anti-seizure medications within 2 months
- Leptomeningeal disease
- 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
- Bleeding diathesis due to underlying medical condition or anticoagulation medication which is unable to be promptly reversed by medical treatment
- Prior additional malignancy that is progressing or has received treatment the previous 3 years
- Active infection requiring systemic treatment
- 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
- Major surgery within 28 days prior to Day 1 and/or minor surgery (excluding biopsy) within 7 days
The study team makes the final eligibility decision.
Where it's taking place
- Randwick, New South Wales, Australia
- Clayton, Victoria, Australia
- Frankston, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Randwick, New South Wales, Australia; Clayton, Victoria, Australia; Frankston, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.