A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
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ClinicalTrials.gov Identifier: NCT06063681 |
Recruitment Status :
Recruiting
First Posted : October 2, 2023
Last Update Posted : November 22, 2023
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Tracking Information | |||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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. Primary Purpose: Treatment |
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Condition ICMJE | Advanced / Metastatic Solid Tumor | ||||
Intervention ICMJE | Drug: SR-8541A
orally administered ENPP1 inhibitor
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Study Arms ICMJE | Experimental: SR-8541A Monotherapy
SR-8541A will be orally administered.
Intervention: Drug: SR-8541A
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |