A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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
  • Exclusion criteria

  • 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 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
  • Troponin I > ULN
  • Blood pressure (BP) - Systolic < 95 mmHg or > 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
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-10-12

    Primary completion: 2024-08-01

    Study completion finish: 2024-08-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

    trial

    Trial ID

    NCT06063681

    Intervention or treatment

    DRUG: SR-8541A

    Conditions

    • Advanced / Metastatic Solid Tumor

    Find a site

    Closest Location:

    Scientia Clinical Research Ltd

    Research sites nearby

    Select from list below to view details:

    • Scientia Clinical Research Ltd

      Randwick, New South Wales, Australia

    • Monash Health

      Clayton, Victoria, Australia

    • Peninsula & South Eastern Haematology & Oncology Group

      Frankston, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: SR-8541A Monotherapy
    • SR-8541A will be orally administered.
    DRUG: SR-8541A
    • orally administered ENPP1 inhibitor

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Frequency and severity of Adverse EventsAdverse events will be graded according to CTCAE v5.0.From first dose of study drug through 30 days following the last dose of study treatment
    Recommended Phase 2 Dose (RP2D) of SR-8541ABased on evaluation of Dose Limiting Toxicities (DLT)From first dose of study drug through 28 days following the first dose of study treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum plasma concentration (Cmax)Cmax measured in ng/mLFrom first dose of study drug through 28 days following the first dose of study treatment
    Area under the curve from zero up to time t (AUC0-t)AUC0-t measured in ng.h/mLFrom first dose of study drug through 28 days following the first dose of study treatment
    Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf)AUC0-inf measured in ng.h/mLFrom first dose of study drug through 28 days following the first dose of study treatment
    Maximal time for peak concentration (Tmax)Tmax measured in hFrom first dose of study drug through 28 days following the first dose of study treatment
    Terminal phase rate constant (λz)λz measured in 1/hFrom first dose of study drug through 28 days following the first dose of study treatment
    Half-life (t1/2)t1/2 measured in hFrom first dose of study drug through 28 days following the first dose of study treatment
    Overall Response RateDefined as the proportion of subjects in the efficacy population who achieve a radiographic investigator-assessed confirmed complete response (CR)/immune CR (iCR) or partial response (PR)/immune PR (iPR) per RECIST v1.1 or immune Response Evaluation Criteria in Solid Tumors (iRECIST) v1.0From first dose of study drug through 2 years following first dose
    Progression Free SurvivalDefined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs firstFrom first dose of study drug through 2 years following first dose
    Duration of ResponseDefined as the time from the date a response of PR or better was first recorded to the date on which PD was first noted or the date of death due to any causeFrom first dose of study drug through 2 years following first dose
    Disease Control RateDefined as the proportion of subjects who achieve an investigator-assessed confirmed CR/iCR, PR/iPR, or Stable Disease (SD)/immune SD (iSD) at 16 weeks per RECIST v1.1 or iRECIST v1.0From first dose of study drug through 2 years following first dose
    Overall SurvivalDefined as the time from the start of treatment until death due to any causeFrom first dose of study drug through 2 years following first dose

    Frequently Asked Questions

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    References

    Clinical Trials Gov: A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors

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