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

Sponsor
Stingray Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06063681
Collaborator
(none)
18
Enrollment
1
Arm
10
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
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.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
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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: SR-8541A Monotherapy

SR-8541A will be orally administered.

Drug: SR-8541A
orally administered ENPP1 inhibitor

Outcome Measures

Primary Outcome Measures

  1. Frequency and severity of Adverse Events [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 [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) [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) [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) [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) [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) [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) [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 [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 [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 [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stingray Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stingray Therapeutics
ClinicalTrials.gov Identifier:
NCT06063681
Other Study ID Numbers:
  • StingrayTx
First Posted:
Oct 2, 2023
Last Update Posted:
Oct 6, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stingray Therapeutics
Refractory
Relapsing
Solid Tumors
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Oct 6, 2023