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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06063681
Recruitment Status : Recruiting
First Posted : October 2, 2023
Last Update Posted : November 22, 2023
Sponsor:
Information provided by (Responsible Party):
Stingray Therapeutics

Tracking Information
First Submitted Date  ICMJE September 23, 2023
First Posted Date  ICMJE October 2, 2023
Last Update Posted Date November 22, 2023
Actual Study Start Date  ICMJE October 12, 2023
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 23, 2023)
  • Frequency and severity of Adverse Events [ Time Frame: From first dose of study drug through 30 days following the last dose of study treatment ]
    Adverse events will be graded according to CTCAE v5.0.
  • Recommended Phase 2 Dose (RP2D) of SR-8541A [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    Based on evaluation of Dose Limiting Toxicities (DLT)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 23, 2023)
  • Maximum plasma concentration (Cmax) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    Cmax measured in ng/mL
  • Area under the curve from zero up to time t (AUC0-t) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    AUC0-t measured in ng.h/mL
  • Area under the concentration time curve from time 0 extrapolated to infinity (AUC0-inf) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    AUC0-inf measured in ng.h/mL
  • Maximal time for peak concentration (Tmax) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    Tmax measured in h
  • Terminal phase rate constant (λz) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    λz measured in 1/h
  • Half-life (t1/2) [ Time Frame: From first dose of study drug through 28 days following the first dose of study treatment ]
    t1/2 measured in h
  • Overall Response Rate [ Time Frame: From first dose of study drug through 2 years following first dose ]
    Defined 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) v1.0
  • Progression Free Survival [ Time Frame: From first dose of study drug through 2 years following first dose ]
    Defined as the time from start of treatment to the first documentation of progressive disease (PD) or death from any cause, whichever occurs first
  • Duration of Response [ Time Frame: From first dose of study drug through 2 years following first dose ]
    Defined 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 cause
  • Disease Control Rate [ Time Frame: From first dose of study drug through 2 years following first dose ]
    Defined 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 v1.0
  • Overall Survival [ Time Frame: From first dose of study drug through 2 years following first dose ]
    Defined as the time from the start of treatment until death due to any cause
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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.

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced / Metastatic Solid Tumor
Intervention  ICMJE Drug: SR-8541A
orally administered ENPP1 inhibitor
Study Arms  ICMJE Experimental: SR-8541A Monotherapy
SR-8541A will be orally administered.
Intervention: Drug: SR-8541A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 23, 2023)
18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Monil Shah 201-978-8032 mshah@stingraytx.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06063681
Other Study ID Numbers  ICMJE StingrayTx
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Stingray Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stingray Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Stingray Therapeutics
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP