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History of Changes for Study: NCT06063681
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Latest version (submitted November 21, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 23, 2023 None (earliest Version on record)
2 October 3, 2023 Study Status
3 October 3, 2023 Arms and Interventions and Study Status
4 November 17, 2023 Recruitment Status, Study Status and Contacts/Locations
5 November 21, 2023 Contacts/Locations and Study Status
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Study NCT06063681
Submitted Date:  September 23, 2023 (v1)
Open or close this module Study Identification
Unique Protocol ID: StingrayTx
Brief Title: A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
Official 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 IDs:
Open or close this module Study Status
Record Verification: September 2023
Overall Status: Not yet recruiting
Study Start: September 2023
Primary Completion: August 2024 [Anticipated]
Study Completion: August 2024 [Anticipated]
First Submitted: September 23, 2023
First Submitted that
Met QC Criteria:		 September 23, 2023
First Posted: October 2, 2023 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 23, 2023
Last Update Posted: October 2, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Stingray Therapeutics
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Advanced / Metastatic Solid Tumor
Keywords: Refractory
Relapsing
Solid Tumors
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Sequential Assignment

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.
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 18 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SR-8541A Monotherapy
SR-8541A will be orally administered twice daily.
 Drug: SR-8541A
orally administered ENPP1 inhibitor
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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)
Secondary Outcome Measures:
1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. 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
9. 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
10. 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
11. 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Monil Shah
Telephone: 201-978-8032
Email: mshah@stingraytx.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services